Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

selective brain radiotherapy based on SIB and hippocampus, inner ear avoidance.

Prescription dose: Gross tumor (PGTV) 40-50 Gy/10 fractions/2 weeks + EBI (PCTV) 30 Gy/10 fractions/2 weeks.

OARs dose limits: Hippocampus D100%≤10Gy, Dmax≤17Gy,Inner ear: Dmean ≤15Gy.

SMART-Brain

Jiang Aijiang, doctor

Yuan Shuanghu, doctor

Jiang Aijun, Doctor

Yuan Shuanghu, Doctor

Brain metastases are the most common intracranial tumors in adults. Whole-brain radiation therapy (WBI) increases the median survival of patients with brain metastases up to 3-6 months, but WBI can lead to the decline of cognition and quality of life, with short local control time. The use of SIB(simultaneous integrated boost) technology can increase the local control rate. Hippocampus avoidance can effectively reduce the cognitive impairment caused by WBI.This study was designed to evaluate the safety and efficacy of selective brain radiotherapy (EBI)(based on SIB and hippocampus, inner ear avoidance )in NSCLCs with limited brain metastases.

In this prospective phase 1 study evaluating the safety and efficacy of selective brain radiotherapy in NSCLCs with limited brain metastases, patients will received selective brain radiotherapy based on SIB and hippocampus, inner ear avoidance.

Prescription dose: Gross tumor (PGTV) 40-50 Gy/10 fractions/2 weeks + EBI (PCTV) 30 Gy/10 fractions/2 weeks.

OARs dose limits: Hippocampus D100%≤10Gy, Dmax≤17Gy,Inner ear: Dmean ≤15Gy. All patients were observed and recorded daily for acute radiation impairment during radiotherapy. Follow-up every 2 months will be performed after radiotherapy.

The primary endpoint:Acute and chronic radiation response, QOL in patients, vestibular function,neurocognitive function based on mini-mental state examination(MMSE) questionnaires, hearing.

The secondary endpoint included:objective response rate (ORR);intracranial progression-free survival (iPFS); OS (defined as the time from study beginning to death from any cause).

Elective Simultaneous Modulated Accelerated Brain Radiation Therapy for NSCLCs With Limited Brain Metastases

Elective Simultaneous Modulated Accelerated Brain Radiation Therapy for NSCLCs With Limited Brain Metastases,A Phase I,One-arm Trial

Shandong Provincial Hospital

Qilu Hospital of Shandong University

The Affiliated Hospital of Xuzhou Medical University

Shandong Cancer Hospital and Institute

Director, Head of of Radiation Oncology, Principal Investigator, Clinical Professor

Rare Diseases

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Cisplatin

Etoposide phosphate

Enzyme Inhibitors

Patients in this group will receive concurrent twice-daily radiotherapy by SIB technique (95%PGTV 54Gy, 95%PTV 45Gy,both in 30 twice-daily fractions over 3 weeks, 5 days per week) and chemotherapy (etoposide and cisplatin).

Patients in this group will receive concurrent twice-daily standard radiotherapy (95%PTV 45Gy in 30 twice-daily fractions over 3 weeks, 5 days per week, without SIB) and chemotherapy (etoposide and cisplatin).

patients will recieve twice-daily radiotherapy by simultaneous integrated boosting technique concurrent with chemotherapy

patients will recieve standard twice-daily radiotherapy concurrent with chemotherapy

Standard

Anhui Shi, Doctor

This trial is a multicenter, perspective, non-blinded, randomized controlled phase 3 trial. In order to establish whether the SIB technique can improve the results of twice-daily chemo-RT for patients with LS-SCLC, the investigators will primarily compare survival of patients treated with standard chemotherapy (cisplatin and etoposide) and either SIB twice-daily RT or standard dose twice-daily RT.

Three hundred and twenty-six patients with a histological or cytological proven diagnosis of SCLC will be recruited from 35 centers in 14 areas including provinces, municipalities and autonomous region, from May 2017 to May 2020.

Twice-daily SIB Radiotherapy Versus Standard Radiotherapy for Patients With SCLC

Twice-daily Radiotherapy by Simultaneous Integrated Boosting Technique Versus Twice-daily Standard Radiotherapy for Patients With Limited-stage Small Cell Lung Cancer: a Multicenter, Randomized, Controlled, Phase III Study

from the starting date of treatment until the date of death from any cause

from the starting date of treatment until the date of local disease progression

from the staring date of treatment until the date of distant metastasis

assessed from completed questionnaires. Assessments using Physicians Global Assessment to measure quality of life.

acute toxicity (defined as toxicity occurring between the start of treatment and up to 3 months after completion of treatment, and assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[version 5.0\]), late toxicity (more than 3 months after completion of treatment, and assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[version 5.0\])

Sun Yat-sen University

Fudan University

Xijing Hospital

Henan Cancer Hospital

Jilin Provincial Tumor Hospital

First Affiliated Hospital of Xinjiang Medical University

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Air Force General Hospital of the PLA

China-Japan Friendship Hospital

Peking University Third Hospital

Peking Union Medical College Hospital

Beijing Hospital

Beijing Chao Yang Hospital

Peking University People's Hospital

Peking University First Hospital

Anhui Shi, MD

associate chief physician

Digestive System Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Capecitabine

Antimetabolites

IMRT-SIB

Surgery

Jasna But-Hadzic, MD

Vaneja Velenik, MD,PhD, asist. prof.

Vaneja Velenik, MD,PhD,asist.prof.

Irena Oblak, MD,PhD,asist.prof.

Franc Anderluh, MD,MSc

Ajra Secerov, MD

Ibrahim Edhemovic, MD,MSc

Erik Brecelj, MD,PhD

Andrej Vogrin, MD

Rihard Hudej

Mirko Omejc, MD,PhD,prof.

Miran Koželj, MD

Bojan Krebs, MD

RATIONALE: Using small radiation beamlets of different intensity, IMRT (intensity modulated radiation therapy) allows shaping the dose around planning target volume with better sparing of normal tissue comparing to 3D conformal radiotherapy. It allows daily delivery of higher dose to the tumor with simultaneous integrated boost (SIB), consequently shortening total treatment time with potentially better response to treatment. In advanced rectal adenocarcinoma excellent response to preoperative radiochemotherapy with complete eradication of the primary tumor observed in the histopathological specimen (pathological complete response, pCR) correlates with a favorable overall prognosis, so trying to achieve better response to preoperative treatment with higher pCR seams feasible.

PURPOSE:The hypothesis of this study is that in preoperative radiochemotherapy for locally advanced rectal adenocarcinoma shortening of the total treatment time with IMRT-SIB to 22 daily fractions concomitant with capecitabine results in an improved pCR rate from 9% (Slovenian trial) to 25%. Secondary objectives are to evaluate pathological down-staging rate, histopathological R0 resection rate, sphincter preservation rate, perioperative surgical complication rate, local control, disease-free survival (DFS), overall survival (OS), late toxicity and quality of life.

IMRT-SIB and Capecitabine in Preoperative Rectal Cancer Treatment

Preoperative Radiochemotherapy With IMRT - Simultaneous Integrated Boost in Locally Advanced Rectal Cancer - BISER

Institute of Oncology Ljubljana

Esophageal Neoplasms

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Docetaxel

Fluorouracil

Simultaneous integrated boost (SIB) used in combination with a fixed dose of radiation (180 cGy in 28 fractions = 5040 Gy PTV dose). Two dose levels (210 cGy and 225 cGy each in 28 fractions) of SIB will be considered in the phase I part of the study, starting at 210 cGy in 28 daily fractions.

For the phase II part of the study once the MTD has been achieved proton therapy will be allowed. Treatment dose will be identical to that of the photon treatment where the PTV is treated to 50.4 Gy(RBE) (RBE=1.1) while the CTV is boosted to 63 Gy(RBE) in 28 fractions.

Chemotherapy Administration: Schedule of chemotherapy, and modifications of chemotherapy drugs during chemoradiation treatment will be at the discretion of the treating medical oncologist per their standard of practice and with consideration to standard chemotherapy drugs in the treatment of esophageal cancer.

Simultaneous integrated boost (SIB) used in combination with a fixed dose of radiation (180 cGy in 28 fractions = 5040 Gy PTV dose). Two dose levels (210 cGy and 225 cGy each in 28 fractions) of SIB will be considered in the phase I part of the study, starting at 210 cGy in 28 daily fractions.

For the phase II part of the study once the MTD has been achieved proton therapy will be allowed. Treatment dose will be identical to that of the photon treatment where the PTV is treated to 50.4 Gy(RBE) (RBE=1.1) while the CTV is boosted to 63 Gy(RBE) in 28 fractions.

Radiation Therapy

James Welsh, MD

The goal of this clinical research study is to find the highest tolerable dose of radiation that can be given in combination with chemotherapy in patients with esophageal cancer that cannot be removed by surgery.

Radiation Therapy:

If you are found to be eligible, you will receive radiation therapy 5 days for 5 weeks. On Week 6, you will receive radiation therapy on 3 days. You will be assigned to a dose level of radiation based on when you join this study. Up to 2 dose levels of radiation will be tested. The first group of participants will receive the lower dose level. The next group will receive a higher dose than the group before it, if no intolerable side effects were seen.

Chemotherapy Administration:

Your medical oncologist and or his/her team will review and discuss all aspects of chemotherapy administration including drugs you will receive, schedule of chemotherapy, and their side effects with you before starting treatment.

Your study doctor may adjust your chemotherapy dose if you experience intolerable side effects.

Study Visits:

You will have weekly study visits while you are receiving radiation therapy. You may have an extra study visit if your doctor thinks it is necessary. At each visit:

* Your complete medical history will be recorded.
* You will have a physical exam, including measurement of your weight and vital signs.
* Your performance status will be recorded.
* You will be asked how you are feeling and about any side effects you may be having.
* Blood ( about 2-3 teaspoons) will be drawn for routine tests.

Length of Study:

You will receive radiation and chemotherapy for up to 6 weeks. You will be taken off study if the disease gets worse or if you experience intolerable side effects.

Visit After the Last Dose:

You will have a study visit 2 weeks (+/- 5 days) after you stop receiving radiation. If you are unable to return to MD Anderson, most of this may be done over the phone. At this visit:

* Your complete medical history will be updated.
* You will be asked how you are feeling and about any side effects that you may be having.
* If the doctor feels it is necessary you will have a physical exam, including measurement of your weight, vital signs, and your performance status will be recorded. If you are unable to travel to this visit, you will not have a physical exam.

Follow-Up Visits:

Your will have follow-up visits after 4 weeks from completing your radiation treatments. Your doctor will decide when you are to return and which tests and procedures will be performed. The following tests and procedures may be performed:

* Your complete medical history may be recorded.
* You may have a physical exam, including measurement of your weight and vital signs.
* You may have a CT or PET scan to check the status of the disease.
* You may be asked how you are feeling and about any side effects you may be having.
* You may have an upper GI endoscopy with biopsies.

If the study doctor thinks it is needed, every year (+/- 2 months), the following tests and procedures will be performed to check the status of the disease:

* You will have a CT or PET/CT scan.
* You may have an upper endoscopy and tumor biopsy.

This is an investigational study. The chemotherapy agents are FDA approved and are commercially available for use in the treatment of esophageal cancer. The higher dose level of radiation in this study is considered investigational.

Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.

Simultaneous Integrated Boost (SIB) in Esophageal Cancer

Phase I/II Study of Evaluating the Safety and Efficacy of Using a Simultaneous Integrated Boost for Dose Escalation in Patients With Esophageal Cancer

MDT defined as CTCAE 3 grade 3 acute radiation toxicity of esophagitis 2 weeks after completion of 6 weeks of radiation therapy.

Local control assessed radiographically using either a PET or CT scan. The one-year local failure rate monitored using the methods of Thall et al.

Complete pathologic response defined as no gross or microscopic tumor in the surgical specimen using light microscopy, but not immunohistochemical stains. Tissue from esophagogastroduodenoscopy can also be used. A partial pathologic response defined as shrinkage in tumor size compared with the original esophagogastroduodenoscopy.

M.D. Anderson Cancer Center

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)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Elective Simultaneous Modulated Accelerated Brain Radiation Therapy for NSCLCs With Limited Brain Metastases	NCT03414944	Brain Metastase...	SMART-Brain	18 Years - 75 Years	Shandong Cancer Hospital and Institute
Twice-daily SIB Radiotherapy Versus Standard Radiotherapy for Patients With SCLC	NCT03214003	Small Cell Lung... Radiotherapy	SIB Standard	18 Years - 70 Years	Peking University Cancer Hospital & Institute
Twice-daily SIB Radiotherapy Versus Standard Radiotherapy for Patients With SCLC	NCT03214003	Small Cell Lung... Radiotherapy	SIB Standard	18 Years - 70 Years	Peking University Cancer Hospital & Institute
IMRT-SIB and Capecitabine in Preoperative Rectal Cancer Treatment	NCT02268006	Rectal Carcinom...	IMRT-SIB Capecitabine Surgery	18 Years - 90 Years	Institute of Oncology Ljubljana
Simultaneous Integrated Boost (SIB) in Esophageal Cancer	NCT01102088	Esophageal Canc...	Radiation Thera...	18 Years -	M.D. Anderson Cancer Center
Elective Simultaneous Modulated Accelerated Brain Radiation Therapy for NSCLCs With Limited Brain Metastases	NCT03414944	Brain Metastase...	SMART-Brain	18 Years - 75 Years	Shandong Cancer Hospital and Institute
Trial of Using SIB-IMRT in Preoperative Radiotherapy for Locally Advanced Rectum Cancer	NCT02195141	Rectal Cancer	conventional fr... SIB	18 Years - 75 Years	ChineseAMS

Spots Global Cancer Trial Database for sib

Every month we try and update this database with for sib 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 sib

Every month we try and update this database with for sib 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 sib 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.