Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Radiotherapy (Total dose: 18\~22 Gy; Single dose: 18\~22 Gy; Frequency: 1) + Sequential chemotherapy

Three dimensional conformal radiation therapy (3D-CRT) (Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30) + Concurrent chemotherapy (Gemcitabine(GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d) + Sequential chemotherapy

Total dose: 18\~22 Gy; Single dose: 18\~22 Gy; Frequency: 1

Intraoperative radiotherapy (IORT)

Sequential chemotherapy

Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30

Three dimensional conformal radiation therapy (3D-CRT)

Gemcitabine (GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d

Concurrent chemotherapy

Jianwei Zhang, Ph.D.

Shuisheng Zhang, M.D.

Chengfeng Wang, B.A.

The purpose of this study is to find the better radiation therapy between intraoperative radiotherapy (IORT) and concurrent chemoradiotherapy (CCRT).

The trial is funded by National High-tech R\&D Program (863 Program). The trial is prepared to be registered on the clinicaltrail.gov.

Quality assurance plan: Every participant is enrolled or excluded by two practiced investigators. And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the workers of research and financial department of The First Affiliated Hospital of China Medical University Data check: The investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms. Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant. Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 100 participants to take part in the trail. The investigators can recruit about 120 participants every year according to previous experiences, so the investigators should recruit at least for one years.

Plan for missing data: The investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results.

Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of survival time between the two groups, and the local control rate of the two groups would be compared by chi square test. Statistical analyses would be performed by using IBM SPSS Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P \< 0.05.

IORT Versus CCRT for Pancreatic Cancer

Intraoperative Radiotherapy (IORT) Versus Concurrent Chemoradiotherapy (CCRT) for Pancreatic Cancer

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Director of Department of Abdominal Surgical Oncolgoy

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients with diagnosis of invasive breast cancer (IBC) will be treated with conservative surgery (with or without oncoplastic surgery) and 20 Gy IORT followed by hypofractionated radiotherapy.

The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery

Intraoperative Radiotherapy (IORT)

Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery

Breast conservative surgery

A External Beam Hypofractionated Radiotherapy will be administered after surgery. y. The dose per fraction will be 2.67 Gy per session. EBRT will be performed daily from Monday to Friday for fifteen fractions.

External Beam Hypofractionated Radiotherapy (EBRT)

Evelyn Martínez, MD

To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy

To evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic surgery) for breast cancer with intraoperative radiotherapy (INTRABEAM) followed by hypofractionated external beam radiotherapy

Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy

Cosmetic Outcomes Following Conservative Surgery (With or Without Oncoplastic Surgery) for Breast Cancer With Intraoperative Radiotherapy (INTRABEAM) Followed by Hypofractionated External Beam Radiotherapy: a Phase II Trial

It will be measured by the BCCT.core software programme. This software uses 4 photographies of the breast for each timepoint and evaluates cosmetic outcome based upon symmetry, skin colour changes and surgical scar appearance. The lower the calculated score, the better the cosmetic outcome (1=excellent, 2=good, 3=fair, 4=poor)

Questionnaire for cosmetic self-evaluation from the Young Boost Trial (YBT) that consists s of 8 questions about various aspects (size, shape, skin colour, massiveness of the breast, nipple position, general appearance, visibility of the surgical scar, and overall satisfaction) to evaluate the degree of satisfaction of the patients themselves about the cosmetic results.

It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-C30

Defined according to the NCI criteria published in the Common Terminology Criteria for Adverse Events (CTCAE) v4.0

Defined as histologically-confirmed evidence of tumour recurrence in the ipsilateral breast

It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-BR23

Institut Català d'Oncologia

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Decompression surgery + IORT (15-20 Gy, 20-50min）

Decompression surgery + postoperative SBRT (30Gy, 5 fractions, 3 weeks)

Intraoperative radiotherapy (IORT, 15-20 Gy, 20-50min)

postoperative stereotactic body radiotherapy (SBRT, 30Gy, 5 fractions, 3 weeks)

Stereotactic body radiotherapy (SBRT)

In order to provide theoretical evidence for the comprehensive and standardized treatment of spinal metastases with pathological fractures and/or spinal cord compression, the investigators conduct this trial to investigate the efficacy and safety of IORT and postoperative SBRT in adjuvant treatment of metastatic spinal tumors after posterior decompression surgery by recruiting patients with spinal metastases who met the inclusion criteria, and randomly divided them into the following treatment cohorts: 1) decompression surgery + IORT (15-20 Gy, 20-50min）; 2) decompression surgery and postoperative SBRT(30Gy, 5 fractions, 3 weeks).

Spine is the most common metastatic site for advanced malignancies, accounting for about 70% of all patients with bone metastasis. Approximately 40% -70% of patients with advanced cancer eventually develop spinal metastases.

Spinal metastases require multidisciplinary treatments, and surgical decompression surgery is the preferred treatment in managing spinal metastases with bone related events, especially those with spinal cord compression. The purpose of decompression surgery is to directly relieve nerve compression, alleviate pain, rebuild spinal stability, and reduce tumor burden, which improves the quality of life, and extend the life span indirectly.

At the same time, radiotherapy is also an indispensable treatment for spinal metastases after surgical decompression. The purpose of radiotherapy is to remove residual tumor lesions, alleviate pain, and prevent further pathological fractures. Recent years have witnessed the rapid development of stereotactic bone radiotherapy (SBRT). As reported, SBRT can not only increase the radiation dose at the tumor site, but also reduce radiation damage to the spinal cord and surrounding normal tissues, which is the preferred adjuvant treatment for patients with metastatic spinal tumors. However, SBRT has the several risks, including radiation myelitis, delayed vertebral pathological fractures, local skin allergies, radiotherapy side effects in the esophagus and lungs, and duodenal perforation. Moreover, stereotactic radiotherapy technology has higher costs compared to traditional external beam radiotherapy.

Recently, the application of intraoperative radiotherapy (IORT) can effectively reduce the direct radiation for surrounding normal tissues and maximally eliminate the residual tumor cells. The advantages of IORT include: ① immediate reduction of the possibility of tumor cell expansion after surgery; ② Safe direct radiation and effective protection of normal tissues beyond the radiation depth; ③ To effectively protect adjacent normal tissues, light-limiting tubes with different diameters can be selected based on the size and range of tumor; ④ Shortening treatment course with lower costs and better compliance; ⑤ Slight systemic side effects and bone marrow suppression.

To the knowledge, no research focuses on the efficacy of IORT and SBRT in the adjuvant treatment of spinal metastases. Therefore, in order to provide theoretical evidence for the comprehensive and standardized treatment of spinal metastases with pathological fractures and/or spinal cord compression, the investigators conduct this trial to investigate the efficacy and safety of IORT and postoperative SBRT in adjuvant treatment of metastatic spinal tumors after posterior decompression surgery by recruiting patients with spinal metastases who met the inclusion criteria, and randomly divided them into the following treatment cohorts: 1) decompression surgery + IORT (15-20 Gy, 20-50min）; 2) decompression surgery and postoperative SBRT(30Gy, 5 fractions, 3 weeks).

1. Decompression surgery + IORT (15-20 Gy, 20-50min）
2. Decomression surgery + postoperative SBRT ( 30Gy, 5 fractions, 3 weeks)

Intraoperative Radiotherapy in Treating Spinal Metastases

The Efficacy and Safety of Intraoperative Radiotherapy Vesus Stereotactic Body Radiotherapy in Managing Spinal Metastases: A Prospective, Single-center, Open-label, Non-inferior, Randomized Controlled Trial

The local control of tumor in the surgical field

The "Functional Assessment of Cancer Therapy -General" (FACT-G) Scale (Minimum: 0; Maximum: 108 ) is utilized to evaluate the health-related quality of life after treatments, and higher scores mean a worse outcome.

The survival time between the day after treatments and the date of any evidence proving tumor progression or final follow-up

The survival time between the day after treatments and the date of all-cause death or final follow-up

The complications assciated with the radiation process

Shanghai Changzheng Hospital

Professor, Chief Surgeon

Carcinoma

Carcinoma, Ductal

Carcinoma in Situ

Breast Carcinoma In Situ

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients just accept nipple-sparing mastectomy (NSM) without radiotherapy.

Followed by nipple-sparing mastectomy (NSM),INTRABEAM IORT was carried out with a single dose of 16 Gy for nipple-areola complex (NAC).

Boost with 16 Gy during NSM for nipple-areola complex (NAC)

INTRABEAM (Carl Zeiss, Oberkochen, Germany)

Liao Ning, MD,PhD

Wen LingZhu

The role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to assess the value of the INTRABEAM system for breast cancer.

Despite the advancement and increasing use of nipple-sparing mastectomy (NSM) is still carried out in a portion of breast cancer patients. However, the role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC). Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation during surgery followed by external-beam radiation to the entire breast may kill more tumor cells.INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative radiotherapy (IORT) device to date. This study aims to broaden the application of the INTRABEAM system for breast cancer, investigating the feasibility of INTRABEAM IORT in NSM with breast reconstruction.

Intra-operative Radiotherapy For Breast Cancer Women After NSM

Intra-operative Radiotherapy For Women With Ductal Carcinoma in Situ Breast Cancer After Nipple-sparing Mastectomy

Within 5 years after surgery,we should evaluate ipsilateral breast tumor recurrence and Disease free survival as the most important outcome measure

Within 5 years after adjuvant chemotherapy,we should evaluateDisease free survival(DFS) rates as thet important outcome measure.

After surgery,we should evaluate overall survival (OR)rates as the secondary important outcome measure.

Liao Ning

MD,PhD

Nervous System Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Intraoperative Radiotherapy (IORT) administered during surgery

If biopsy is positive, local treatment with IORT will be performed. After IORT (15,40 Gray at 2 mm dept), the applicator will be removed and surgery will be continued in a standard fashion.

Surgery should be performed according to the local standard of care, preferentially as image-(neuronavigation) guided surgery. To establish the diagnosis of a metastasis and to exclude primary CNS tumors, lymphomas, SCLCs or germinomas it will be performed a peroperative biopsy

Brain surgery

Miquel Macià, MD

Anna Lucas, MD

To evaluate the feasibility and efficacy of the Intraoperative Radiation Therapy (IORT) after the resection of a brain metastases to reduce the incidence of local relapse

IORT After Surgical Resection of Brain Metastases

IORT After Surgical Resection of Brain Metastases: Feasibility and Efficacy Phase II Trial

Time span (in months) between surgery and recurrence within a 0,5 cm margin around the resection cavity, evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.

The time (in months) from surgery to any progression outside of the 0,5 cm margin around the resection cavity, evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.

Time (in months) from surgery to any intra- and extracranial tumor progression evaluated through Response Assessment in Neuro-Oncology (RANO) criteria for brain metastasis obtained from serial Magnetic resonance imaging (MRI) scans.

Time (in days) from surgery to the day of initiation of any systemic anti-tumor therapy (e.g., chemotherapy)

Time (in months) from surgery of brain metastases to death by any cause

Assessed by minimal mental scale examination

Assessed by number repetition test (forward and backward)

Assessed by controlled oral word association test

Assessed by European Organization for Research and Treatment (EORTC)- Quality of Life Questionnaires (QLQ C30/BN20)

Assessed by regular neurological examinations combined by serial MRI scans

Behaviors and Mental Disorders

Quality of Life

Hormones

IORT (20Gy) as intervention will be given during breast conserving surgery. If risk factors (Tumor \> 3.5 cm, lobular cancer, resection margin \< 2 mm\*, L1, pN+ mulitfocal/multicentric, EIC, negative hormone receptors) are present, external beam radiotherapy will be added.

\* In case of positive margins (\<2 mm resection margin) a re-resection should be done

The surgeon and radiation oncologist should choose the largest possible suitable applicator in order to ensure that the highest possible dose is delivered to the tumor bed tissue. A dose of 20 Gy at the surface of the applicator (in water) is prescribed by the radiation oncologist and delivered to the breast tissue. This takes approximately 20-50 minutes, depending on the size of the applicator.

To minimize radiation dependent side effects the skin-applicator surface distance should be more than 5 mm.

Elena Sperk, MD

This prospective, multicentric single arm phase IV study is based on the protocol of the international TARGIT-A and TARGIT-E study.

Patients ≥ 50 years with small, low-risk breast cancer who are operated but not irradiated show local relapse rates around 6% after 5 years. With adjuvant whole breast radiotherapy (WBRT) the local relapse rate drops to under 1% after 5 years under Tamoxifen (4).

It has been demonstrated (6, 9, 10) that the efficacy of radiation of the tumor bed only in a selected group can be non-inferior to WBRT.

The TARGIT C study should confirm the efficacy of a single dose of intraoperative radiotherapy (IORT) in a well selected group of patients with small breast cancer and absence of risk factors. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines.

Endpoints are the local relapse rate (within 2 cm of the tumor bed), ipsilateral relapse, cancer-specific and overall survival and contralateral breast cancer as well as documentation of quality of life and cosmetic outcome.

The expected local relapse rates are 0.825/1.375% after 3/5 years, respectively. Discontinuation of the trial is scheduled if rates of local relapse rates rise to 1.55/2.4/4% after 1/3/5 years. Power calculations result in 387 patients with a calculated dropout and loss to follow-up rate of 10%, an alpha of 0.05 and a beta of 0.10. There will be only a pre-pathology stratum.

It is a pragmatic trial in which each participating centre has the option to modify entry criteria and criteria for WBRT according to this core protocol after consultation with the steering committee and local ethics committee (e.g. size, free margins). Only centers with access to the Intrabeam® system (Carl Zeiss) can recruit patients into the trial.

1. Introduction

   Randomized studies provide evidence that concerning the overall survival breast conserving surgery (BCS) combined with postoperative radiotherapy is equally effective as modified mastectomy (1, 2, 3). Postoperative radiation decreases the local relapse rate (1, 2) highly significantly in comparison to BCS alone (3). The recent metaanalysis of the Early Breast Cancer Trialists Collaborative Group (EBCTCG (3)) show that the avoidance of 4 local relapses after 5 years can prevent one death in 15 years (4 to 1 rule).

   Several studies in the past demonstrated that complete omission of radiotherapy failed in terms of local tumor control. Fyles et al. (4) showed local relapse rates of 8% within a low risk group of patients with tumors of pathological stage T1/T2 and \>50 years of age treated with BCS and antihormonal treatment (AHT). By adding postoperative whole breast radiation (WBRT) the rate of local relapse was reduced to 1% after 5 years. This effect was also seen in elderly patients with small tumors. Hughes et al. (5) observed low local relapse rates of 4% for patients treated with AHT only after BCS vs. 1% for patients with additional WBRT after 4 years, evaluating a low-risk group of patients with tumors \< 2 cm and \> 70 years of age. Apparently, all patients benefit from postoperative WBRT. However, due to the fact that 90% of all local relapses after breast conserving therapy are localized very close to the primary tumor, it might be possible to treat a selected group of patients with a relatively low risk of local recurrence with tumor bed irradiation only. Polgar et al. (6) provided evidence of the non-inferiority of accelerated partial breast irradiation (APBI) in comparison to WBRT in a small randomized trial. Very recently the TARGIT-A data (9, 10) reported a non-inferior efficacy of tumor bed irradiation with single dose intraoperative radiation (Intrabeam System, Carl Zeiss Oberkochen) compared to WBRT regarding local relapse.

   By using the Intrabeam System, the intraoperative radiotherapy (IORT) can be given during surgery with protection of the surrounding tissue while applying a biologically highly effective dose to the tissue adjacent to the tumor.

   Advantages of IORT are its high precision regarding beam application, its possibility of protection of the skin and the prevention of tumor cell proliferation during the time interval between breast conserving surgery and adjuvant WBRT as well as during fractionated WBRT.

   By manually positioning of the applicator in the tumor bed geographic miss is excluded and radiation of risk structures like the heart and lung can be avoided. Therefore, it is possible to give a high single fraction to the target and minimize relevant side effects.
2. Aim

The objective of this single armed phase IV study is to further investigate the efficacy of a single intraoperative radiotherapy treatment within low risk patients (≥ 50 years, cT1 and small cT2 (\< 3.5 cm), cN0, cM0, invasive-ductal, hormone receptor positive) which is followed by WBRT only when risk factors are present.

The primary endpoint is the rate of local relapse (within 2 cm of the initial tumor); secondary endpoints are ipsi- or contralateral breast cancer, cancer specific and overall survival. Of further interest is the cosmetic outcome and Quality of Life.

Therefore, patients ≥ 50 years with small, histologically verified and hormone receptor positive invasive-ductal breast cancer (clinically cT1 or small T2 ≤ 3.5 cm) without risk factors (multifocality/- centricity, extensive intraductal component (EIC), lymph vessel invasion (L1), clinically positive lymph nodes) who receive BCS will be recruited.

After tumor resection with free margins \> 1 mm the applicator will be exactly positioned in the tumor bed with a minimum distance to skin of 5 mm. The prescription dose will be 20 Gy to the surface of the applicator. The treatment times depend on the diameter of the applicator and can last up to 20-50 minutes. After radiation the applicator will be removed and the operation finished as usual. The biologic effectiveness of 20 Gy prescribed during the operation is equivalent to 70 Gy normo-fractionated irradiation according to radiobiological modelling.

If the final histopathological report provides evidence of a different histology or risk factors, such as an extensive intraductal component (EIC), lymph vessel invasion (L1), multifocality/-centricity or resection margins \<2 mm, patients will receive a postoperative WBRT with 46 Gy (after a delay of at least 5 weeks). Depending on the lymph node status postoperative WBRT will be performed with 50 Gy (pN1) or WBRT including lymphatic drainage with 50 Gy (≥ pN2). A re-resection has to be performed in presence of insufficient free margins (e.g. tumor on ink, or margin \< 2mm depending on local policy) and will be followed by WBRT with 50 Gy omitting the boost.

Cosmetic outcome and toxicity evaluation will be performed by chart (CTC and LENT-SOMA score) and standardized photo documentation.

For Quality of Life assessment the patients will complete two standardized and validated questionnaires developed by the EORTC (European Organisation for Research and Treatment of Cancer). The questionnaires include 53 questions and take approximately 10 minutes and will be filled out at clinic visits.

Therefore, a patient group including patients ≥ 50 years with a low-risk tumor profile will be treated in this single-arm study by intraoperative radiotherapy of the tumor bed only, using a well established method (Intrabeam System, Carl Zeiss Surgical, Oberkochen, Germany) in order to optimize radiotherapy treatment after breast conserving surgery in terms of local relapse, toxicity, overall survival and quality of life.

Single arm study: IORT +/- EBRT (risk adapted approach).

TARGIT-C(Consolidation) Prospective Phase IV Study of IORT in Patients With Small Breast Cancer

TARGIT-C(Consolidation) Prospective Phase IV Study of Intraoperative Radiotherapy (IORT) in Patients With Small Breast Cancer

Local relapse rate within 2 cm of the tumor bed

Breast cancer related and overall survival

Cosmetic outcome, acute and late toxicity measured by CTC Score V5 and LENT SOMA scale (fibrosis, telangiectasia, edema arm, edema breast, ulceration, hyperpigmentation, pain, retraction

measured by EORTC QLQ C30 and BR23 questionnaires; longitudinal analysis

Universitätsmedizin Mannheim

Head, Clinical Trials Unit, Department of Radiation Oncology Mannheim

intraoperative radiotherapy (IORT) during brain tumor resection to establish a maximum tolerated dose (MTD) through a dose-escalation trial using intraoperative radiotherapy (IORT)

intraoperative radiotherapy (IORT)

Shaio Woo, MD

The primary purpose of this study is to establish a maximum tolerated dose (MTD) through a dose-escalation trial using intraoperative radiotherapy (IORT) following neurosurgical resection for large brain metastases, and to determine the progression-free survival rate as in the recurrence rate of treated brain metastasis.

The potential for delivering ablative doses of radiation to the tumor bed while simultaneously sparing normal brain parenchyma from significant doses of radiation and reducing the potential for tumor repopulation has led to interest in the use of intraoperative radiotherapy (IORT) for brain metastasis.

The resection procedure should be performed with image guidance (neuronavigation) with standard surgical technique.

Optimal balloon applicator size will be selected with accordance to tumor bed/cavity geometry and adjacent normal brain parenchyma by the team of surgeons and radiation oncologists.

The radiation oncologist will place the miniature x-ray source inside the balloon shaped catheter placed inside the tumor cavity. Radiotherapy will be initiated by the treating radiation oncologist for a defined time interval calculated by the machine planning software.

After IORT has been delivered, the surgeon will remove the balloon applicator. Surgery will be continued in the regular fashion without additional requirements.

Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection

A Phase I/II Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection

No plans to share individual participant data with other researchers outside of this clinical trial's investigation team

Maximum tolerated dose will be determined by classical 3+3 dose-escalation design. Toxicity will be measured using the National Cancer Institute Common terminology criteria for adverse events (version 5.0).

The first dose of 18Gy will be administered to the first 3 subjects, after 90 days from treatment a safety assessment for dose limiting toxicities will be done to determine if the next 3 subject will escalation to dose of 21Gy or receive 18Gy.

If escalation to 21Gy is permitted, then after 90 days from treatment a safety assessment for dose limiting toxicities will be done to determine if next cohort of 3 subjects will escalate to a dose of 24Gy or receive 21Gy. The highest dose level to be administered will be 24 Gy if permitted by safety assessments.

Number of adverse events reported per participant.

University of Louisville

Principal Investigator

Zero participants accrued in cohorts 2 and 3.

Participants receiving Intraoperative Radiotherapy with Neurosurgical Resection.

Cohort 1: 18 Gy

Planned participants receiving Intraoperative Radiotherapy with Neurosurgical Resection.

Cohort 2: 21 Gy

Cohort 3: 24 Gy

Intraoperative Radiotherapy Treatment Arm

3 screen failed and 1 withdrew and were unable to be analyzed.

Age, Categorical

3 screen failed and 1 withdrew and were not analyzed.

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

Shiao Woo, MD Principal Investigator

18 Gy

21 Gy

24 Gy

IORT Treatment Arm

Established Maximum Tolerated Dose

participants that received intraoperative radiation.

Number of Participants With Adverse Events

Cohort 1 received 18 Gy. Intraoperative radiotherapy (IORT) during brain tumor resection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
IORT Versus CCRT for Pancreatic Cancer	NCT02981641	Pancreatic Canc...	Intraoperative ... Sequential chem... Three dimension... Concurrent chem...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy	NCT05498311	Breast Cancer	Intraoperative ... Breast conserva... External Beam H...	45 Years -	Institut Català d'Oncologia
Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy	NCT05498311	Breast Cancer	Intraoperative ... Breast conserva... External Beam H...	45 Years -	Institut Català d'Oncologia
IORT Versus CCRT for Pancreatic Cancer	NCT02981641	Pancreatic Canc...	Intraoperative ... Sequential chem... Three dimension... Concurrent chem...	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Intraoperative Radiotherapy in Treating Spinal Metastases	NCT06093854	Spinal Metastas...	Intraoperative ... Stereotactic bo...	35 Years - 75 Years	Shanghai Changzheng Hospital
Intra-operative Radiotherapy For Breast Cancer Women After NSM	NCT02389686	Breast Neoplasm...	INTRABEAM (Carl...	17 Years - 80 Years	Guangdong Academy of Medical Sciences
IORT After Surgical Resection of Brain Metastases	NCT05084092	Brain Neoplasms	Intraoperative ... Brain surgery	18 Years -	Institut Català d'Oncologia
TARGIT-C(Consolidation) Prospective Phase IV Study of IORT in Patients With Small Breast Cancer	NCT02290782	Breast Cancer	Intraoperative ...	50 Years -	Universitätsmedizin Mannheim
Intraoperative Radiotherapy in Treating Spinal Metastases	NCT06093854	Spinal Metastas...	Intraoperative ... Stereotactic bo...	35 Years - 75 Years	Shanghai Changzheng Hospital
Intra-operative Radiotherapy For Breast Cancer Women After NSM	NCT02389686	Breast Neoplasm...	INTRABEAM (Carl...	17 Years - 80 Years	Guangdong Academy of Medical Sciences
Study of Intraoperative Radiotherapy for Patients With Large Brain Metastases Treated With Neurosurgical Resection	NCT04040400	Brain Metastase...	intraoperative ...	18 Years -	University of Louisville
IORT After Surgical Resection of Brain Metastases	NCT05084092	Brain Neoplasms	Intraoperative ... Brain surgery	18 Years -	Institut Català d'Oncologia

Spots Global Cancer Trial Database for intraoperative radiotherapy (iort)