Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
ReRT Trial Summary
This trial is testing whether proton therapy can be a better way to treat tumors that have come back after previous radiation therapy, compared to other approaches.
Who is the study for?
This trial is for adults over 18 who've had radiation therapy before and now have recurring tumors. It's open to those with various cancers, including lung, brain, breast, gastrointestinal, and more. Participants need a recent physical exam and an ECOG performance status of 0-2. Those with severe non-cancer diseases or certain cancer histories are excluded.Check my eligibility
What is being tested?
The study tests Proton Therapy as a targeted treatment for tumors that have returned after previous radiation therapy. Unlike traditional photon radiation that affects tissues beyond the tumor, Proton Therapy aims to deliver higher doses directly to the tumor while sparing surrounding healthy tissue.See study design
What are the potential side effects?
While specific side effects aren't listed here, proton therapy generally aims to reduce side effects by avoiding unnecessary exposure of healthy tissues compared to traditional radiation treatments.
ReRT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
ReRT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening,
Varies for treatment, and 5 years for reporting.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the cumulative rate of CTCAE v5.0 Grade ≥3 acute and late treatment related adverse events within 1 year of definitive reirradiation completion using proton therapy for recurrent or second primary tumor.
Secondary outcome measures
To characterize patient reported outcomes within 1 year of reirradiation using the CTB COMP forms for intracranial tumors.
To characterize patient reported outcomes within 1 year of reirradiation using the MDASI BT forms for intracranial tumors.
To characterize patient reported outcomes within 1 year of reirradiation using the MDASI SP form for spinal tumors.
+5 more
ReRT Trial Design
8Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 7: GynecologicalExperimental Treatment1 Intervention
Group 1: Locally recurrent gynecological cancer within previous field
Single arm, prospective, phase II study design
Patients with history of gyn cancer for which definitive or adjuvant/salvage PORT was given, now with recurrence within 50% IDL recommended for radiotherapy
At least 1 year between RT courses
No persistent grade 3+ toxicity from prior RT
Concurrent chemotherapy excluded
Uncontrolled or widely metastatic disease
Life expectancy >6 months
Group II: Cohort 6: GenitourinaryExperimental Treatment1 Intervention
Group 1 Locally recurrent prostate cancer w/in prev. radiation field Phase II
Patients w/recurrent prostate adenocarcinoma w/in prev. irradiated field w/indication for repeat course of radiation
Min. 1 year interval b/w RT courses
Prostate gland or recurrent tumor <100 cc or 6 cm in largest dimension
No persistent grade 2+ toxicity from prior radiation
Negative metastatic workup (bone scan, CT scan or PSMA/axumin scan
Group 2 Regional prostate cancer recurrence adjacent to the previous field Phase II
Patients w/recurrent prostate adenocarcinoma beyond prior RT field (outside 50% IDL) but w/in pelvis)
Min.1 year interval b/w RT courses (EBRT or brachy)
No persistent grade 2+ toxicity from prior radiation
Group 3 Prostate Reirradiation Registry
Patients w/recurrent prostate adenocarcinoma (prostate gland, postop bed, or pelvi c LN) who require RT to the prostate or pelvis in the setting of prior pelvis RT
No DM
Concurrent chemotherapy excl.
Group III: Cohort 5: GastrointestinalExperimental Treatment1 Intervention
Group 1 Esophagus & GEJ Reirradiation Phase II
Patients w/history of E/GEJ cancer s/p RT, now w/recurrent/new primary nonmetastatic E/GEJ cancer for which salvage RT is recommended
Negative metastatic workup
Group 2 Liver Reirradiation Phase II
Patients w/history of HCC, cholangiocarcinoma or liver mets (any histology), s/p prior EBRT, now with in field recurrence/new primary/met, for which definitive reRT is recommended
CTP A or B7
Excl. prev. Y 90/radioembolization
Allow prior TACE
Overlap w/50% IDL prior RT
Adequate bone marrow function
Group 3 Lower GI Reirradiation Phase II
Patients w/history of rectal/anal cancer s/p RT now w/recurrent/new primary nonmetastatic rectal/anal cancer for whom salvage RT is recommended +/ chemotherapy
Negative metastatic workup (PET/CT or CT C/A/P)
Group 4 GI Reirradiation Registry
•Patients w/histologically document recurrent or new GI malignancy with prior history of RT w/overlap of current RT volume by the 50% IDL
Group IV: Cohort 4: ThoracicExperimental Treatment1 Intervention
Group 1: Definitive Reirradiation for Locally Advanced Disease
Single arm, prospective, phase II study
Patients with a history of lung cancer s/p definitive RT , now with local recurrence of new primary centrally located and w/I 50% IDL of prior RT field
Definitive reRT concurrent systemic therapy
Adequate pulmonary function defined as an FEV1 of >35% (with or without bronchodilator) within 90 days prior to registration
Minimum 6 month interval between RT courses
Negative metastatic workup
Group 2: Thoracic Registry Study
Registry design
Patients with histologically confirmed thoracic malignancy (NSCLC, SCLC , mesothelioma, thymoma, carcinoid, intrathoracic sarcoma) with prior thoracic RT
Minimum 3 month interval between RT courses
Negative metastatic workup
Group V: Cohort 3: BreastExperimental Treatment1 Intervention
Group 1 Partial Breast Reirradiation (Phase II)
Patients with a history of breast cancer s/p BCT, now with small (≤3cm), unicentric, ipsilateral breast cancer recurrence receiving repeat BCT
Node negative
Negative margins
No LVI
Lumpectomy cavity:whole breast <30%
Minimum 1 year interval between RT courses
Group 2: Regional LN and Breast/CW ReRT (Phase II)
Patients with a history of breast cancer s/p RT , now with recurrence or new primary with indication for reirradiation to the breast/chest wall and regional LN
Minimum 1 year interval between RT courses
Negative metastatic workup (PET/CT or CT C/A/P + bone scan)
Excludes concurrent chemotherapy
Group 3: Breast Reirradiation Registry
Patients with a history of breast cancer s/p RT , now with recurrence or new primary breast cancer with indication for reirradiation
Some overlaps of dose with prior RT course
Negative metastatic workup (PET/CT or CT C/A/P + bone scan)
Excludes concurrent chemotherapy
Group VI: Cohort 2: Head/NeckExperimental Treatment1 Intervention
Group 1 Full Dose Reirradiation Phase II
Patients w/history of HNC for which RT was delivered definitively, now with recurrence to h/n amenable to full dose reRT
Gross unresected disease or PORT 2/2 RF
Received at least 40 Gy overlapping w/new target region
Min. 6 month interval b/w RT courses
Overlap of prior RT field (50% IDL)
Subgroup analysis: surgery, HPV status, concurrent ST
Group 2 Early (<6months for prior RT) Palliative H/N ReRT Phase I
Patients w/history of HNC for which RT was delivered definitively/adjuvant setting, now with biopsy proven recurrence to h/n with indication for palliative RT
At least 30 Gy prior RT overlapping with new treatment volume
<6 month interval between RT courses
Group 3 Head/Neck ReRT Registry
Patients w/history of HNC for which RT was delivered now with recurrence/secondary primary requiring reRT
Postop or definitive
Prior RT dose at least 30 Gy overlapping w/new treatment volume
Min.6 month interval b/w RT courses
Group VII: Cohort 1: Central Nervous SystemExperimental Treatment1 Intervention
Group 1 Definitive Reirradiation Phase II
Patients w/history of intracranial or spinal (extradural, intradural, and/or intramedullary) CNS tumors for which radiation therapy was prev. delivered either to gross disease or in the postoperative setting
Min. 6 month interval b/w RT courses
Overlap of prior RT field (50% IDL)
Subgroup analysis: receipt of surgery for recurrence/second IC tumor; concurrent ST; tumor histology
Group 2 CNS Reirradiation Registry
Patients for whom a repeat course of RT to the CNS is indicated for recurrent disease or secondary primary
Postop or intact setting
Min. 6 month interval b/w RT courses
Overlap of prior RT field (50% IDL)
Histologically/clinically documented recurrent CNS tumor (benign or malignant)
Glioblastoma (histologic or molecular including IDH wildtype)
Astrocytoma (molecular IDH1 mutant)
Oligodendroglioma (molecular 1p19q co deleted)
Meningioma
Ependymoma
Chordoma/chondrosarcoma
Group VIII: Cohort 8: RegistryActive Control1 Intervention
Registry design
Any cancer patient for whom RT is indicated in the setting of prior RT and do not meet eligibility criteria for other cohorts
Overlap of 50% IDL of current treatment volume with prior RT field
0 / 1Eligibility criteria met
Find a Location
Who is running the clinical trial?
The New York Proton CenterLead Sponsor
1 Previous Clinical Trials
61 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:
I don't have any health conditions that would stop me from participating in the study.I have been cancer-free from another type of cancer for over 3 years.I have a history of conditions like lupus, scleroderma, or dermatomyositis.I am 18 years old or older.I've been mostly active and able to care for myself in the last 3 months.I have a type of cancer that is not expected to shorten my life, such as non-melanoma skin cancer or low-risk prostate cancer.
Research Study Groups:
This trial has the following groups:
Group 1: Cohort 6: Genitourinary
Group 2: Cohort 7: Gynecological
Group 3: Cohort 8: Registry
Group 4: Cohort 1: Central Nervous System
Group 5: Cohort 3: Breast
Group 6: Cohort 4: Thoracic
Group 7: Cohort 5: Gastrointestinal
Group 8: Cohort 2: Head/Neck
Awards:
This trial has 1 awards, including:
No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:
Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
Treatment: The duration you will receive the treatment varies.
Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have been recruited to this research endeavor?
"Affirmative. Clinicaltrials.gov has information that reveals this trial is still open for recruitment, having first been posted on January 24th 2022 and most recently updated on March 29th of the same year. At present, 1800 patients are required from 1 individual medical site."
Answered by AI
Is there still opportunity to enroll in this clinical experiment?
"Yes, according to information stored on clinicaltrials.gov, this trial is actively recruiting. The posting was first uploaded on January 24th 2022 and has been revised most recently on March 29th 2022. This study requires 1800 people from a single site for participation."