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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-03311 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| IRB#11-044/OER-RT-042 | Other Identifier | Fox Chase Cancer Center |
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This phase I trial studies the side effects and best dose of 3-dimensional conformal radiation therapy (CRT) or intensity-modulated radiation therapy (IMRT) in treating patients with recurrent tumors. Radiation therapy (RT) uses high energy x rays to kill tumor cells. Palliative radiation therapy may help patients with recurrent tumors live more comfortably.
PRIMARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of reirradiation with the pulsed low dose rate technique.
SECONDARY OBJECTIVES:
I. To investigate the dosimetric tolerance of normal structures to reirradiation with the pulsed low dose rate technique.
II. To determine the palliative efficacy and quality of life in patients treated on this protocol.
III. To determine duration of response and time to progression.
OUTLINE: This is a dose-escalation study.
Patients undergo 3-dimensional CRT or IMRT once daily (QD), 5 days a week for 10-30 days. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every month for 6 months and then every 12 weeks thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (radiation therapy) | Experimental | Patients undergo 3-dimensional CRT or IMRT QD, 5 days a week for 10-30 days. Treatment continues in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quality-of-life assessment | Procedure | Ancillary studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD of reirradiation with the pulsed low dose rate technique | Defined as the dose level closest to, but not over that which is predicted to result in a dose limiting toxicity (DLT) rate of 20%, the target toxicity rate. Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A DLT is a grade >= 4 acute or grade >= 3 late toxicity of an organ system within the reirradiation field in the following categories: skin or subcutaneous tissues, gastrointestinal, hepatobiliary, nervous system, renal and urinary, reproductive system, vascular, or respiratory, thoracic and mediastinal disorders. | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Palliative efficacy in terms of quality of life and pain levels | Assessed using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 15 Palliative (QLQ-C15-PAL) and the Numeric Pain Scale. The mean and standard deviation will be estimated at each time point. | Up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| C-M Charlie Ma, PhD | Fox Chase Cancer Center | Principal Investigator |
| Josphua Meyer, MD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
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| intensity-modulated radiation therapy | Radiation | Undergo IMRT |
|
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| 3-dimensional conformal radiation therapy | Radiation | Undergo 3-dimensional CRT |
|
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| Duration of response |
Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves. |
| Up to 3 years |
| Time to progression | Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves. | Up to 3 years |
| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| D020266 | Radiotherapy, Conformal |
| ID | Term |
|---|---|
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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