Back to resultsProspective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors (ReRT)
CNS Cancer, Head and Neck Cancer, GI Cancer
About this trial
This is an interventional treatment trial for CNS Cancer focused on measuring Reirradiation, Cancer, Proton Therapy, Radiation Therapy
Eligibility Criteria
Inclusion Criteria:
- Age 18 years
- Patient provides study specific informed consent prior to study entry.
- Documented history and physical exam within 90 days prior to registration.
- ECOG PS 0, 1, or 2 within 90 days prior to registration
Exclusion Criteria:
- Non malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up.
Prior invasive non study malignancy unless disease free for ≥ 3 years
- Non melanoma skin cancer, low risk prostate cancer, well differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible.
- History of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum
Sites / Locations
- The New York Proton CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
No Intervention
Cohort 1: Central Nervous System
Cohort 2: Head/Neck
Cohort 3: Breast
Cohort 4: Thoracic
Cohort 5: Gastrointestinal
Cohort 6: Genitourinary
Cohort 7: Gynecological
Cohort 8: Registry
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 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 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 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 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 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 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
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
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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