Neoplasms

All Conditions

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Rare Diseases

Sarcoma

Ichthyosis, X-Linked

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

The treatment will be administered in 25 daily fractions (Monday-Friday) at the disease site to include the region of suspected micrometastatic spread (Clinical Target Volume 1, CTV1) at a dose of 50 Gy (2Gy

/ fraction) with SIB intensification on volume reduced corresponding to the interface sites between the tumor and the vascular / nerve axes (Clinical Target Volume 2, CTV2) at a dose of 60 Gy (2.4 Gy / fraction). The association with neoadjuvant chemotherapy based on anthracyclines is allowed.

Marta Pacinico

lorenzo livi

lorenzo livi, Dr

Intervention prospective monocentric one arm study on the use of neoadjuvant radiotherapy with simultaneous integrated boost (Simultaneous Integrated Boost, SIB) in patients with STS with indication for preoperative radiotherapy. The treatment will be administered in 25 daily fractions (Monday-Friday) at the disease site to include the region of suspected micrometastatic spread (Clinical Target Volume 1, CTV1) at a dose of 50 Gy (2Gy

/ fraction) with SIB intensification on volume reduced corresponding to the interface sites between the tumor and the vascular / nerve axes (Clinical Target Volume 2, CTV2) at a dose of 60 Gy (2.4 Gy / fraction). The association with neoadjuvant chemotherapy based on anthracyclines is allowed.

Intervention prospective monocentric one arm study on the use of neoadjuvant radiotherapy with simultaneous integrated boost (Simultaneous Integrated Boost, SIB) in patients with STS with indication for preoperative radiotherapy. The treatment will be administered in 25 daily fractions (Monday-Friday) at the disease site to include the region of suspected micrometastatic spread (Clinical Target Volume 1, CTV1) at a dose of 50 Gy (2Gy

/ fraction) with SIB intensification on volume reduced corresponding to the interface sites between the tumor and the vascular / nerve axes (Clinical Target Volume 2, CTV2) at a dose of 60 Gy (2.4 Gy / fraction). The association with neoadjuvant chemotherapy based on anthracyclines is allowed. Objective: The primary objective is to evaluate the benefit of radiotherapy with partial simultaneous integrated boost to the area at risk of incomplete resection in the neoadjuvant treatment of soft tissue sarcoma candidate for conservative surgery. The secondary objectives are to evaluate the outcomes and toxicity Study population: Patients with de novo or locoregional recurrence of STS after surgery.

Estimated enrollment: 33 Inclusion criteria: STS candidate for surgical resection; age \> 18 years Exclusion criteria: previous radiotherapy over the region of interests, inability to express informed consent; planned amputation. Study arm: Intensity Modulated Radiotherapy Study duration: 2 years Enrollment period: 3 years Global study duration: 5 years Current primary outcomes measures: Oncologically negative resection rate (R0 rate) Current secondary outcomes measures: Pathologic Complete Response rate (pCR); Overall Survival (OS); Disease Specific Survival (DSS) Local-Relapse Free Survival (LRFS); Distant-Metastases-Free Survival (DMFS); incidence of acute and late toxicity according to CTCAE v5.0 classification

Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)

Azienda Ospedaliero-Universitaria Careggi

Professor

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Oxaliplatin

Antimetabolites

The intervention of Experimental group includes: Radiotherapy, followed by chemotherapy with capecitabine, oxaliplatin, and then surgery. The detail of procedure: 1, short-course preoperative radiotherapy(SCPRT) , which consists of SCPRT, 5 Gray(Gy) x 5, 4Gy for boost on the gross tumour volume(GTV) with MRI-simulation alone; 2,then after 7-10 days of radiotherapy completed, patients will receive consolidation chemotherapy, given in 3 week cycle of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once. In total, 4 cycles of neoadjuvant chemotherapy are prescribed preoperatively, then followed by a total mesorectal excision(TME) and postoperative adjuvant chemotherapy.

The intervention of Control group includes:Radiotherapy, capecitabine, and surgery. The detail of procedure: 1, long-term chemoradiotherapy(CRT), which consists of a long-term chemoradiation (2 Gy x 25 with capecitabine) preoperatively; 2, 6-8 weeks after chemoradiation, total mesorectal excision(TME) and then postoperative adjuvant chemotherapy. The radiotherapy is given in combination with capecitabine in a dose of 825 mg/m2 twice daily on days when radiotherapy, excluding weekends.

Short-course preoperative radiotherapy(SCPRT), which consists of 5 Gy x 5f and 4Gy for boost on the GTV with MRI-simulation alone.

SCPRT

Long-term chemoradiotherapy(CRT), which consists of a long-term chemoradiation (2 Gy x 25 with capecitabine) preoperatively.

Patients will receive consolidation chemotherapy after 7-10 days of SCPRT completed, given in 3 week cycle of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once. In total, 4 cycles of neoadjuvant chemotherapy are scheduled before surgery.

CAPOX

Jing Jin, M.D.

Wen-Yang Liu, M.D.

Jing Jin, MD

Improvements in downstaging are required when using preoperative chemoradiation for unresectable rectal cancer. There is therefore a need to explore more effective schedules. The study arm will receive MRI simulation-guided boost in short-course preoperative radiotherapy followed by consolidation chemotherapy , which may enhance the shrinkage of tumor comparing with the concurrent chemoradiation.

The study is a prospective phase II randomized multicenter trial. The purpose of this study is to compare short-term radiotherapy with MRI simulation-guided boost followed by consolidation chemotherapy(Experimental group) with preoperative long-term chemoradiotherapy(Control group) for middle-lower unresectable locally advanced rectal cancer evaluated by MRI. The primary endpoint is the rate of R0 resection and cCR, and the secondary objectives are local recurrence-free survival, distant metastasis-free survival, disease-free survival and overall survival at 3-year and 5-year follow up. Furthermore, pathological complete response rate, the acute and late toxicity profile and quality of life (QOL) after 3 years follow-up are secondary endpoints. The exploratory end point includes the circulating tumor DNA, and other potential biomarkers from tumor tissue and blood sample for treatment response and survival predicting. For each group, a plan for collection of serum/plasma/feces at baseline and different stages during or after treatment and for obtaining fresh tumor tissue for freezing prior to treatment was defined in the protocol.

The SUNRISE-trial has been designed by National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, and the hypothesis is R0 resection rate in Experimental group was superior to that in Control group.

Interim analysis design: As a phase II trial, the safety of experimental intervention is a major concern. We took the toxicity data from STELLAR, a phase III randomized study led by our center, as a reference. The incidence of G3 and above side effects in the short course radiotherapy with sequential neoadjuvant chemotherapy group was 28%, and that in the standard long-course concurrent chemoradiotherapy control group was 5%. Considering that boost dose may increase toxicity, if severe toxicity in the study group significantly exceeds that in the control group by more than 35%, it is up to the principal investigator to decide whether to modify the study protocol or terminate the study. The sample size of the interim analysis was calculated by the Z-pooled test, with α=0.05 (one-sided test), 1-β=0.90, using PASS 11 software. The frequency of the toxicity of G3 and above should be compared when neoadjuvant therapy was completed in 21 patients enrolled in each group.

MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer

MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy (SCPRT) Followed by Consolidation Chemotherapy Versus Long Course Chemoradiation for Unresectable Rectal Cancer

The exploratory end point for predicting of treatment response and survival. The circulating tumor DNA test by sequencing will includes KRAS, NRAS, BRAF,PI3K,TP53,PTEN, EGFR, NEGF etc (509-gene panel). And Measuring change in T cell receptor sub-types during treatment.Single cells test by cytof. Cytokines test by the Olink Proteomics panel.

The composite outcome of R0 (microscopically margin-negative) resection and cCR, that is, the combined rate of radical resection and cCR management after neoadjuvant treatment.

the time from surgery to local recurrence

pathological complete response in surgery specimen

clinical complete response evaluated by MDT

the frequency of acute adverse events during and after treatment in 1-month, including gastrointestinal (vomiting, diarrhea and incontinence), dermatitis, and hematologic toxicity evaluated weekly by the Common Terminology Criteria 4.0.

the late toxicity after treatment completion for 1-month, the frequency of late adverse events after 1-month of treatment, including gastrointestinal function, fistula, and hematologic toxicity, evaluated regularly by LENT-SOMA scoring systems.

general quality of life of patients evaluated by questionaire of EORTC QLQ-C30. The higher score in total indicates the worse quality of life in general.

quality of life related to colorectal disease of patients evaluated by questionaire of EORTC QLQ-CR29. The higher score in total of this module indicates the worse quality of life by colorectal module.

the rate of sustained clinical complete response plus rate of R0 resection

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Professor, Director of medical services

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

The low risk cohort will receive:

Stereotactic Ablative Body Radiotherapy as Monotherapy on the CyberKnife System

The high risk cohort will receive:

28 treatments of external beam radiation therapy followed by Stereotactic Ablative Body Radiotherapy as a Boost on the CyberKnife System and hormonal therapy as indicated.

The prescribed planned tumor volume (PTV) dose of 36.25 Gy shall be given in 5 fractions using CyberKnife Hypofractionated Stereotactic Ablative Body Radiation Therapy. PTV will be defined per parameters outlined in the protocol and will at minimum include the entire prostate gland.

Stereotactic Ablative Body Radiotherapy as Monotherapy

The prescribed planned tumor volume (PTV) dose of 27.5 cGy shall be given in 5 fractions using CyberKnife Hypofractionated Stereotactic Ablative Body Radiation Therapy as a boost following 5040 cGy with external beam. PTV will be defined per parameters outlined in the protocol and will at minimum include the entire prostate gland. Hormonal therapy will given as indicated in the protocol.

Stereotactic Ablative Body Radiotherapy as a Boost

Javier Zuniga

Kristina Go-Alejo

Marielou Keuth, CRC

Asif Harsolia, MD

Nisar Syed, MD

Ajmel Puthawala, MD

Linda Chan, MD

Joel Cherlow, MD

Anil Sharma, PhD

Junaid Pasha, MD

The purpose of this study is to determine the side effects and how effective CyberKnife stereotactic ablative body radiation (SABR) is in patients with prostate cancer. The CyberKnife system is a new type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal. The purpose of this evaluation is to see if this treatment will help patients with your condition and to evaluate the effect of this treatment on your quality of life over time.

Due to the advances in being able to detect early stage prostate cancer better than before, more men diagnosed with the disease are able to be cured. Methods of prostate cancer treatment include having laparoscopic surgery, having open surgery to remove the prostate, receiving radiation therapy, or brachytherapy (placing high energy x-rays to destroy the cancer cells). Although these treatment options have the potential to cure patients, these treatments have their drawbacks. The healing time following the removal of the prostate can be substantial and local treatments from standard radiation and brachytherapy have potentially negative long term effects. The CyberKnife system is a new type of radiation machine that uses a special system to precisely focus large doses of x-rays on the tumor. The device is designed to concentrate large doses of radiation using robotic image guidance onto the tumor specifically so that injury from radiation to the nearby normal tissue would be minimal. The high doses of radiation directly to the tumor would provide a shorter series of treatments and a faster recovery time. The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with prostate cancer. The purpose of this evaluation is to see if this treatment will help patients with low to intermediate risk prostate cancer and to evaluate the effect of this treatment on the patient's quality of life over time.

Prior to entrance on this study patients will already have had your prostate specific antigen (PSA) checked and a prostate biopsy within the last 12 months. The results of the biopsy showed that the patient has prostate cancer. In addition, patients will have had a digital rectal exam (DRE) to determine if the cancer can be felt. Based on the results of these tests and examination it has been determined that the patient's prostate cancer is in an early stage and has not likely spread outside the prostate or anywhere else in his body. If the patient agrees to be in this study, he will be asked to read and sign this consent form before having any procedure that is required for participation. The patients will be asked to complete some short questionnaires before his CyberKnife treatment. These questionnaires will ask multiple choice questions about the patient's bowel, bladder and sexual function. They will also ask the patient some general questions about his mood, activity and energy levels, and general health. The patient will also have a physical examination and a procedure to place 3 to 5 small gold seeds into the prostate. This procedure is commonly done in patients receiving standard external beam radiation (a type radiation treatment) for prostate cancer and is not an experimental procedure. These gold markers will be used to determine the location of the prostate during the CyberKnife treatment. An ultrasound probe is placed into the rectum and needles containing the gold seeds are guided into the prostate and then the seeds are deposited. The patient will need to clean out his rectum and take antibiotics the day of the seed placement. Within 5-10 days after placement of the gold seeds, the patient will be asked to return to the hospital to have a planning CT scan (a procedure that takes 3-D images) of the pelvis. This is a regular CT scan and is standard procedure for patients receiving external beam irradiation. The images obtained during the scan will be used to plan the CyberKnife treatments. The patient will also have an MRI scan of the pelvis, unless medically contraindicated (for example if he has a pacemaker) which will be used for treatment planning purposes. The patient may be asked to undergo these scans with a urethral catheter in place. The CyberKnife treatment will usually be started after the CT scan of the pelvis. The patient's course of radiation will consist of five separate CyberKnife treatments usually delivered over 5 week days (maximum 14 days), with no less than 12 hours between any two fractions. Each treatment session will take approximately 1.5-2.5 hours. Depending on the risk level of your prostate cancer, the physician may also ask you to have a five week course of external beam radiation therapy prior to the CyberKnife patients and some patients will be asked to go on hormonal therapy. The patient will lie on the treatment table and breathe normally while you receive your radiation treatment. On the last day of treatment a research team member will ask the patient questions about possible side effects. After CyberKnife treatment the patient will need follow-up visits to determine how effective the treatment was and if he is having any treatment related side effects. At 1-2 weeks after treatment is completed, a member of the research team will call you and discuss how you are doing. At 1 month after completion of the CyberKnife treatment, the patient will be asked to return to the hospital for a follow-up examination to check for any side effects. The patient will also be asked to complete the same questionnaires you completed prior to CyberKnife treatment. These questionnaires will ask about hid bowel, bladder and sexual functioning, as well as mood, activity and energy levels, and general health. At 3 and 6 months after completion of the CyberKnife treatment, the patient will be asked to return to your physician for an examination and a blood test to measure your PSA level. This is the standard procedure for follow-up visits and will occur every 6 months thereafter for 5 years. At some of these visits, you also will be asked to complete questionnaires about your bowel, bladder and sexual functioning and your quality of life. If it is suspected that your tumor is growing or if there are concerns about disease progression on the patient's PSA exams, a prostate needle biopsy of the tumor may be performed.

Primary Objective: The primary safety goal of this study is to estimate, in both low-risk and high-risk cohorts, the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed following CyberKnife SABR for prostate cancer. The primary efficacy goal is to document the rate of biochemical Disease-Free Survival (bDFS) using the Phoenix and American Society of Therapeutic Radiation and Oncology definitions, at 5 years.

Secondary Objective: To measure the following in the study population: Rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival; quality of life (QOL) in generic and organ-specific domains;

Evaluation of CyberKnife Stereotactic Radiotherapy in Prostate Cancer

Prospective Evaluation of CyberKnife Stereotactic Body Radiotherapy for Localized Prostate Cancer: Risk Stratified Monotherapy Versus Boost

The primary safety goal of this study is to estimate, in both low-risk and high-risk cohorts, the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed following CyberKnife SABR for prostate cancer. The primary efficacy goal is to document the rate of biochemical Disease-Free Survival (bDFS) using the Phoenix and American Society of Therapeutic Radiation and Oncology definitions, at 5 years.

To measure the following in the study population: Rates of local failure, distant failure, disease-free survival, disease-specific survival, and overall survival; quality of life (QOL) in generic and organ-specific domains;

MemorialCare Health System

Boost radiation consists of 5 fractions of 3 Gy (total 15 Gy) delivered to the tumor (Gross Tumor Volume) additional to standard chemoradiation of 50 Gy with Capecitabine.

Standard chemoradiation consisting of 25 x 2 Gy (total 50 Gy) with Capecitabine.

External Beam radiation delivered using intensity modulation radiation therapy (IMRT) planning, consisting of 15 Gy (in 5 sequential fractions).

Boost

HM Verkooijen, MD PhD

M. Berbee, MD PhD

Randomized controlled trial in which the effect is investigated of a radiation boost in addition to standard chemoradiation in patients with locally advanced rectal cancer on complete response rate defined as pathological complete response, in those who undergo surgery, or 2-years local recurrence-free survival (2y-LRFS), in those who opted for a wait and see approach. Secondary objectives are adverse events due to chemoradiation (acute, perioperative and late toxicity), tumor response assessed with MRI, the impact of the boost on local and distant recurrence and survival as well as patient-reported quality of life and workability. The need for this comprehensive study is emphasized by the sub-optimal (radiation-) methods, heterogeneity between and poor reporting in the few previous trials in this field.

Rationale: The current treatment for locally advanced rectal cancer consists of pre-operative chemoradiation treatment (CRT) (50 Gray (Gy) in 25 fractions) followed by surgical resection, according to T-/N-stage, circumferential resection margin (CRM) and tumor localization (see table 1). After this neo-adjuvant treatment approximately 15% of patients show pathological complete response (pCR), i.e.no residual tumor in the resected specimen on pathologic examination. Patients with pCR have a lower risk of local and distant recurrences and significantly longer disease-free and overall survival. Furthermore, in these patients surgery could possibly have been omitted. Selected patients with a clinical complete response (cCR), defined prior to surgery by rectoscopy, rectal examination and magnetic resonance imaging (MRI), may opt for an organ-preserving therapy, a so called wait and see approach.

Response to chemoradiation occurs in a dose dependent fashion. Therefore, recent trials aimed to improve prognosis by radiation dose-escalation that resulted in improved pCR rates. Toxicity rates associated with radiation doses above 60 Gy are manageable and differ between studies; from increased to comparable or even lower toxicity. Moreover, dose escalation may increase the proportion of patients eligible for organ-preserving therapy.

Objective: We study whether addition of a radiation boost to standard chemoradiation in patients with locally advanced rectal cancer increases the complete response rate defined as pathological complete response, in those who undergo surgery, or 2-years local recurrence-free survival (2y-LRFS), in those who opted for a wait and see approach. Secondary objectives are adverse events due to chemoradiation (acute, perioperative and late toxicity), tumor response assessed with MRI, the impact of the boost on local and distant recurrence and survival as well as patient-reported quality of life and workability. The need for this comprehensive study is emphasized by the sub-optimal (radiation-) methods, heterogeneity between and poor reporting in the few previous trials in this field.

Study design: Multicentre Randomized Controlled Trial, nested within a prospective cohort according to the 'cohort multiple randomized controlled trial' (cmRCT) design.

Study population: Rectal cancer patients participating in a prospective cohort (the PLCRC project) and diagnosed with adenocarcinoma of the rectum whom will undergo chemoradiation based on clinical criteria (see table 1 section 1.2.1).

Intervention: An irradiation boost of 15 Gy delivered to the gross tumor volume (GTV) in 5 fractions in addition to the standard chemoradiation treatment of 50 Gy. Thereby increasing the total GTV dose to 65 Gy.

Main study parameters/endpoints: The primary endpoint is complete response either defined as pathological complete response (pCR) in patients who undergo surgery, assessed by standardized pathologic examination of the surgical specimen, or 2-years local recurrence-free survival (LRFS) after chemoradiation in patients who opted for a wait and see approach. Secondary outcomes are treatment acute, perioperative and late toxicity, tumor response assessed with MRI, patient-reported quality of life and workability, local recurrence and (disease-specific) survival.

cohort multiple randomized controlled trial

RECTAL BOOST Study

RandomizEd Controlled Trial for Pre-operAtive Dose-escaLation BOOST in Locally Advanced Rectal Cancer

The primary endpoint is complete response either defined as pathological complete response (pCR) in patients who undergo surgery, assessed by standardized pathologic examination of the surgical specimen, or 2-years local recurrence-free survival (LRFS) after chemoradiation in patients who opted for a wait and see approach.

Outcomes are assessed according to Common Toxicity Criteria for Adverse Events (CTCAE) (v4.0).

at baseline and 3, 6, 12 and 24 months after treatment. Patient reported outcome (Quality of life (QoL)) is measured by validated questionnaires.

QoL: European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and CR-29 (these acronyms indicate cancer and colorectal cancer specific questionnaires.

During (week 2) and after (7-8 weeks post) chemoradiation tumor response is assessed by (several) MRI (sequences such as T1, T2 and DWI).

validated questionnaires. Patient reported outcome (workability) is measured by Workability index.

Dutch Surgical Colorectal Audit criteria for surgical complication. This includes wound-infection, wound-healing (time), hospitalization (time), supportive treatment.

Survival is measured, as well as other clinical data, in the PICNIC Cohort (ProspectIve data CollectioN Initiative on Colorectal cancer) reviewed by Dutch Medical Ethics Committee @ University Medical Center Utrecht, under number 12-510.

Maastro Clinic, The Netherlands

UMC Utrecht

Principle Investigator

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Temozolomide

78Gy in 30 fractions on FET-PET based target volumes;

60Gy in 30 fractions on 2cm margin from MRI based target volumes;

all patients will be treated with concomitant and adjuvant temozolomide

Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost

The combination of anatomical MRI examination with functional examination of tissue metabolic activity such as FET-PET (PET using the radiotracer - 18F-fluoro-ethyl-tyrosine) is a valuable tool to determine the actual tumor infiltration. The FET-PET examination can be performed using the dual-time point aqusition of FET for exact treatment planning. It has also been proven that using the dual FET-PET method, it is possible to obtain a precise image of the glioblastoma infiltration corresponding to the location and shape of the recurrence, and the tumor volumes in dual FET-PET are significantly larger than in MRI. Moreover, tumor defined in dual FET-PET is different than that of the tumor defined in single FET-PET acquisition.

In the DualFETboosT trial we plan to assess the safety and preliminary efficacy of hypofractionated irraditon using simultaneous in-field boost directed on dual FET-PET based tumor volumes for treatment of primary glioblastoma multiforme with concomitant temozolomide.

In the case of the treatment of glioblastoma multiforme, as a standard, radiotherapy lasts 6 weeks, and the extension of treatment may adversely affect the tumor cells death, the patient's well-being and treatment costs (prolonged hospitalization). In turn, escalating the dose may increase the toxicity of radiation therapy by increasing DNA damage in healthy brain tissue. Using of dual FET-PET images for treatment planning allow to reduce volumes of healthy tissue irradiated. Dose-intensification proposed in the study using simultaneous in-field boost allows the dose escalation without increasing the overall treatment time. All patient will be treated with moderately hypofractionated radiotherapy (2.6 Gy per fraction) directed on PET positive volumes and conventional fractionation (60Gy in 30 fractions) on tumor margin.

FET-PET Directed Simultaneous In-field Boost for Primary GBM

Safety and Preliminary Efficacy of Hipofractionated Irradiation Based on Dual FET-PET in Patients With Primary Glioblastoma Multiforme With Concomitant Temozolomide

From date of surgery until the date of death from any cause, Correlation between FET uptake and survival

From date of surgery until the date of death from any cause, percent of patient that are alive 1 and 2 years after surgery

from the date of surgery until progression of the disease or the date of death from any cause assessed

according to Rano criteria; from the end of radiation therapy

from the end of radiation therapy up to progression until progression of the disease or the date of death from any cause; according to irradiation field

from the end of radiation therapy up to progression until progression of the disease or the date of death from any cause; histopathological diagnosis of radiation necrosis

from the end of radiation therapy up to progression until progression of the disease or the date of death from any cause; CTCAE grade 3 or higher

Prof. Franciszek Lukaszczyk Memorial Oncology Center

M.D Ph.D.

Radiotherapy (25x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily

Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily

capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f

conventional fraction

Jing Jin, Professor

Hua Ren, Attending

Jing Jin, professor

Hua Ren, attending

Jing Jin, proffessor

Pathological complete response, (pCR) correlates with a favorable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pCR might be beneficial. The aim of the study is to investigate safety and efficacy of preoperative SIB-IMRT(56Gy) combine with capecitabine. primary endpoint is pathological complete remission rate.

Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer

Randomized Phase II Tiral of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer

Followup will be done every 3 months in first 2 years, and every 6 months after 2 years.

Acute toxicities will be assessed every week during chemoradiation period , one week before surgery(6 weeks after chemoradiation) and every 3 months after surgery for 2 years.Late toxicities will be assessed every 6 months from the 3rd year for 3 years.Adverse eventswill be evaluated according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Chinese Academy of Medical Sciences

Attending physician

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Boost with 20 Gy during BCS, EBRT with 46-50 Gy

Intraoperative radiotherapy with the INTRABEAM System with 20 Gy

IORT with 50 kV x-rays, 20 Gy

Elena Sperk, MD

Quality Control Registry for IORT used as an anticipiated boost with 20 Gy at the applicator surface followed by EBRT

Quality Control Registry of a standard treatment with intraoperative radiotherapy during breast conserving surgery with 20 Gy at the applicator surface as an advanced boost followed by a shortened external beam radiotherapy. This is a prospective phase IV study to evaluate real life data of IORT Boost. Study runs in Germany with 13 active centers recruiting. Due to the nature of the study (registry) there is no need for randomization. Inclusion of n = \>1000 patients is planned.

TARGeted Intraoperative radioTherapy With INTRABEAM as a Boost for Breast Cancer - A Quality Control Registry

TARGeted Intraoperative radioTherapy With the INTRABEAM-System as an Advanced Boost in Patients With Breast Cancer - A Quality Control Registry in Germany (TARGIT BQR)

LENT SOMA Scale for toxicity regular follow up

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)	NCT05761054	Soft Tissue Sar...	RT	18 Years -	Azienda Ospedaliero-Universitaria Careggi
MRI Simulation-guided Boost in Short-course Preoperative Radiotherapy for Unresectable Rectal Cancer	NCT03714490	Rectal Neoplasm...	SCPRT CRT CAPOX	18 Years - 70 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Evaluation of CyberKnife Stereotactic Radiotherapy in Prostate Cancer	NCT02016248	Prostate Cancer	Stereotactic Ab... Stereotactic Ab...	18 Years -	MemorialCare Health System
RECTAL BOOST Study	NCT01951521	Rectal Cancer	Boost	18 Years -	UMC Utrecht
FET-PET Directed Simultaneous In-field Boost for Primary GBM	NCT04790097	Glioblastoma Mu...	Moderately Hypo...	18 Years -	Prof. Franciszek Lukaszczyk Memorial Oncology Center
Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer	NCT02195141	Rectal Cancer	conventional fr... SIB	18 Years - 75 Years	ChineseAMS
TARGeted Intraoperative radioTherapy With INTRABEAM as a Boost for Breast Cancer - A Quality Control Registry	NCT01440010	Breast Cancer	IORT with 50 kV...	18 Years - 85 Years	Universitätsmedizin Mannheim

Spots Global Cancer Trial Database for boost

Every month we try and update this database with for boost cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for boost

Every month we try and update this database with for boost cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for boost cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.