Proton Therapy for Recurrent Cancer

(ReRT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The New York Proton Center

Disqualifiers: Connective tissue disorders, Non malignant systemic disease, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical research trial is to study the use of differing investigational doses and scheduling for Proton Therapy for tumors previously treated with radiation therapy. Generally, when patients are first treated for cancer with radiation therapy, they are treated with traditional photon (or x-ray) radiation therapy, which uses high-energy waves to kill tumor cells. In some cases, the cancer either returns or a new tumor can present in a different part of the body. With the usual radiation treatment, the photon beams travel all the way through the body. As a result, healthy tissues in front of and behind the tumor are exposed to radiation. Physicians who treat these cases where the tumor has returned often use a much lower dose of radiation to prevent patients from experiencing serious and long-term side-effects. This dose is often not strong enough to destroy the cancerous tumor. Alternatively, they may also treat a smaller area than would be indicated for complete tumor eradication, again in an attempt to prevent serious and long-term toxicities, but at the cost of optimally treating the cancer. Proton therapy, however, may offer a chance to safely deliver a more effective dose and volume of radiation as it is more targeted and can spare healthy tissues surrounding the tumor. The reason we are conducting this research study is to look at whether Proton therapy can be a better way to treat reoccurring tumors in patients who have previously received radiation therapy to the same area, compared to treatment approaches used to date.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Proton Therapy for Recurrent Cancer?

Research shows that intensity modulated proton therapy (IMPT) can improve the precision of radiation delivery, sparing healthy tissue while effectively targeting cancer cells. This has been observed in conditions like pancreatic, thoracic, and esophageal cancers, suggesting potential benefits for recurrent cancer as well.

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Is proton therapy generally safe for humans?

Proton therapy, including intensity modulated proton therapy (IMPT), has been used in treating various cancers like pancreatic, head and neck, and anal cancer. It is known for its ability to target tumors more precisely, potentially reducing damage to surrounding healthy tissues and lowering the risk of side effects compared to traditional radiation therapy. Initial studies suggest it is promising and generally safe, but ongoing research is needed to fully understand its safety profile.

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How is proton therapy different from other treatments for recurrent cancer?

Proton therapy, specifically intensity-modulated proton therapy (IMPT), is unique because it can precisely target tumors while minimizing damage to surrounding healthy tissues, unlike traditional radiation therapies. This precision is particularly beneficial for recurrent cancers where sparing normal tissue is crucial.

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Eligibility Criteria

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.

Inclusion Criteria

Patient provides study specific informed consent prior to study entry

Documented history and physical exam within 90 days prior to registration

I am 18 years old or older.

Exclusion 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.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive investigational doses of Proton Therapy for tumors previously treated with radiation therapy

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Participant Groups

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.

Group I: Cohort 7: Gynecological Experimental Treatment 1 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: Genitourinary Experimental Treatment 1 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: Gastrointestinal Experimental Treatment 1 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: Thoracic Experimental Treatment 1 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: Breast Experimental Treatment 1 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/Neck Experimental Treatment 1 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 System Experimental Treatment 1 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: Registry Active Control 1 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

Proton Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Proton Therapy for:

• Head and neck cancer
• Pediatric cancers
• Spine tumors
• Breast cancer
• Sarcoma
• Brain tumors
• Prostate cancer

🇪🇺 Approved in European Union as Proton Therapy for:

• Head and neck cancer
• Pediatric cancers
• Spine tumors
• Breast cancer
• Sarcoma
• Brain tumors
• Prostate cancer

🇨🇦 Approved in Canada as Proton Therapy for:

• Head and neck cancer
• Pediatric cancers
• Spine tumors
• Breast cancer
• Sarcoma
• Brain tumors
• Prostate cancer

🇯🇵 Approved in Japan as Proton Therapy for:

• Head and neck cancer
• Pediatric cancers
• Spine tumors
• Breast cancer
• Sarcoma
• Brain tumors
• Prostate cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The New York Proton Center New York, NY

Who Is Running the Clinical Trial?

The New York Proton Center Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Initial experience with intensity modulated proton therapy for intact, clinically localized pancreas cancer: Clinical implementation, dosimetric analysis, acute treatment-related adverse events, and patient-reported outcomes. [2022] Pencil-beam scanning intensity modulated proton therapy (IMPT) may allow for an improvement in the therapeutic ratio compared with conventional techniques of radiation therapy delivery for pancreatic cancer. The purpose of this study was to describe the clinical implementation of IMPT for intact and clinically localized pancreatic cancer, perform a matched dosimetric comparison with volumetric modulated arc therapy (VMAT), and report acute adverse event (AE) rates and patient-reported outcomes (PROs) of health-related quality of life.

2. United States pubmed.ncbi.nlm.nih.gov

Clinical implementation of intensity modulated proton therapy for thoracic malignancies. [2022] Intensity modulated proton therapy (IMPT) can improve dose conformality and better spare normal tissue over passive scattering techniques, but range uncertainties complicate its use, particularly for moving targets. We report our early experience with IMPT for thoracic malignancies in terms of motion analysis and management, plan optimization and robustness, and quality assurance.

3. United States pubmed.ncbi.nlm.nih.gov

Clinical outcomes of intensity modulated proton therapy and concurrent chemotherapy in esophageal carcinoma: a single institutional experience. [2022] Intensity-modulated proton therapy (IMPT) is an emerging advanced radiation technique. Although dosimetric studies demonstrate the superiority of IMPT for improving target conformity and reducing unnecessary dose to critical normal tissues, clinical experience is limited. We aim to describe our preliminary experience implementing IMPT concurrently with chemotherapy in esophageal carcinoma (EC).

4. United States pubmed.ncbi.nlm.nih.gov

Radiotherapy treatment of early-stage prostate cancer with IMRT and protons: a treatment planning comparison. [2020] To compare intensity-modulated photon radiotherapy (IMRT) with three-dimensional conformal proton therapy (3D-CPT) for early-stage prostate cancer, and explore the potential utility of intensity-modulated proton therapy (IMPT).

5. England pubmed.ncbi.nlm.nih.gov

Intensity modulated proton therapy. [2018] Intensity modulated proton therapy (IMPT) implies the electromagnetic spatial control of well-circumscribed "pencil beams" of protons of variable energy and intensity. Proton pencil beams take advantage of the charged-particle Bragg peak-the characteristic peak of dose at the end of range-combined with the modulation of pencil beam variables to create target-local modulations in dose that achieves the dose objectives. IMPT improves on X-ray intensity modulated beams (intensity modulated radiotherapy or volumetric modulated arc therapy) with dose modulation along the beam axis as well as lateral, in-field, dose modulation. The clinical practice of IMPT further improves the healthy tissue vs target dose differential in comparison with X-rays and thus allows increased target dose with dose reduction elsewhere. In addition, heavy-charged-particle beams allow for the modulation of biological effects, which is of active interest in combination with dose "painting" within a target. The clinical utilization of IMPT is actively pursued but technical, physical and clinical questions remain. Technical questions pertain to control processes for manipulating pencil beams from the creation of the proton beam to delivery within the patient within the accuracy requirement. Physical questions pertain to the interplay between the proton penetration and variations between planned and actual patient anatomical representation and the intrinsic uncertainty in tissue stopping powers (the measure of energy loss per unit distance). Clinical questions remain concerning the impact and management of the technical and physical questions within the context of the daily treatment delivery, the clinical benefit of IMPT and the biological response differential compared with X-rays against which clinical benefit will be judged. It is expected that IMPT will replace other modes of proton field delivery. Proton radiotherapy, since its first practice 50 years ago, always required the highest level of accuracy and pioneered volumetric treatment planning and imaging at a level of quality now standard in X-ray therapy. IMPT requires not only the highest precision tools but also the highest level of system integration of the services required to deliver high-precision radiotherapy.

6. United States pubmed.ncbi.nlm.nih.gov

Proton radiation therapy for head and neck cancer. [2018] Due to the close spatial relationship of head and neck and skull base tumors to numerous normal anatomical structures, conventional photon radiation therapy can be associated with significant acute and long-term treatment-related toxicities. Superior dose localization properties of proton radiation therapy allow smaller volumes of normal tissues to be irradiated than is feasible with any photon technique. Intensity-modulated proton therapy (IMPT) is a powerful delivery technique which results in improved dose distribution as compared to that of intensity-modulated radiation therapy (IMRT). Initial clinical experience with proton radiation therapy in treatment of head and neck and skull base tumors is promising. Prospective multi-institutional trials are underway to define the role of proton radiation therapy, particularly IMPT, in the treatment of head and neck and skull base tumors.

7. United States pubmed.ncbi.nlm.nih.gov

Hematologic Toxicity Comparison of Intensity Modulated Proton Therapy and Intensity Modulated Radiation Therapy in Anal Cancer Patients. [2023] We hypothesize that hematologic toxicity will be lower in anal cancer patients treated definitively with intensity modulated proton therapy (IMPT) compared with patients treated with intensity modulated radiation therapy (IMRT).

8. United States pubmed.ncbi.nlm.nih.gov

Intensity-modulated proton therapy for nasopharyngeal carcinoma: Decreased radiation dose to normal structures and encouraging clinical outcomes. [2022] Intensity-modulated proton therapy (IMPT) has the potential to spare dose to organs at risk (OAR) when compared to intensity-modulated radiotherapy (IMRT) while maintaining excellent clinical outcomes.