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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Central Nervous System | Experimental | Group 1 Definitive Reirradiation Phase II
Group 2 CNS Reirradiation Registry
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| Cohort 2: Head/Neck | Experimental | Group 1 Full Dose Reirradiation Phase II
Group 2 Early (<6months for prior RT) Palliative H/N ReRT Phase I
Group 3 Head/Neck ReRT Registry
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pencil Beam Scanning Proton Therapy | Radiation | Use of Pencil Beam Scanning Proton Therapy compared with historical outcomes using photon therapy for the reirradiation of recurrent or new primary malignancies |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the 1 year freedom from local failure. | 1 year | |
| To determine the 1 year freedom from progression free survival. | 1 year | |
| To determine the 1 year freedom from overall survival. |
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Inclusion Criteria:
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
History of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan Holder, BS | Contact | 646-968-9055 | 387 | research@nyproton.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The New York Proton Center | Recruiting | New York | New York | 10035 | United States |
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Phase: Registry, Phase I, Phase II Study Design/Methodology: Cohort-defined, single arm prospective study
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| Cohort 3: Breast | Experimental | Group 1 Partial Breast Reirradiation (Phase II)
Group 2: Regional LN and Breast/CW ReRT (Phase II)
Group 3: Breast Reirradiation Registry
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| Cohort 4: Thoracic | Experimental | Group 1: Definitive Reirradiation for Locally Advanced Disease
Group 2: Thoracic Registry Study
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| Cohort 5: Gastrointestinal | Experimental | Group 1 Esophagus & GEJ Reirradiation Phase II
Group 2 Liver Reirradiation Phase II
Group 3 Lower GI Reirradiation Phase II
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 |
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| Cohort 6: Genitourinary | Experimental | Group 1 Locally recurrent prostate cancer w/in prev. radiation field Phase II
Group 2 Regional prostate cancer recurrence adjacent to the previous field Phase II
Group 3 Prostate Reirradiation Registry
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| Cohort 7: Gynecological | Experimental | Group 1: Locally recurrent gynecological cancer within previous field
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| Cohort 8: Registry | No Intervention |
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| 1 year |
| To determine the acute cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 90 days of reirradiation completion. | 90 days |
| To determine the late cumulative rate of CTCAE v5.0 Grade ≥3 treatment related adverse events at 2 years of reirradiation completion. | 2 years |
| To characterize patient reported outcomes within 1 year of reirradiation using the MDASI BT forms for intracranial tumors. | 1 years |
| To characterize patient reported outcomes within 1 year of reirradiation using the CTB COMP forms for intracranial tumors. | 1 years |
| To characterize patient reported outcomes within 1 year of reirradiation using the MDASI SP form for spinal tumors. | 1 year |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D011471 | Prostatic Neoplasms |
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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