Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the feasibility of using proton radiotherapy for reirradiation of recurrent malignancies.
Patients will be stratified by treatment site (Head and Neck, Thorax, Abdomen, Pelvis, Extremities) and by treatment volume (low volume, high volume) for a total of 10 strata. This study will be done in two phases. In the first phase, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 90 days after the last patient in the initial phase has completed treatment in each strata and once feasibility has been verified. The secondary objectives will serve as the objectives for the second phase of the study.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| small volume strata | Active Comparator | 12 in small volume strata |
|
| large volume strata | Active Comparator | 12 in large volume strata |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proton Radiotherapy | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of proton therapy | To determine if the study is infeasible, defined if greater than 10% of pts experience one of the following:
| 90 days |
| Acute Toxicity | Acute Toxicity is defined as any grade 4 toxicity observed within 90 days from the initiation of radiotherapy that is felt to be directly related to their proton treatment. Toxicities will be graded by NCI CTC Version 4.0 | within 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Late toxicity | Late toxicity is defined as any grade 3 or higher toxicity observed later than 90 days from start of therapy. Late toxicities will be graded according to the RTOG/EORTC late morbidity scoring system. | open-ended |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Plastaras, MD, PhD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Marcio Fagundes, MD | Procure, Oklahoma City, OK | Principal Investigator |
| William F. Hartsell, MD | ProCure Proton Therapy Center, Warrenville, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProCure Proton Therapy Center | Warrenville | Illinois | United States | |||
| Procure |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oklahoma City |
| Oklahoma |
| 73142 |
| United States |
| Abamson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |