3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Recurrent Tumors
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: quality-of-life assessment
Radiation: intensity-modulated radiation therapy
Radiation: 3-dimensional conformal radiation therapy
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Pulsed Low Dose Rate Reirradiation Delivered With 3DCRT/IMRT for Palliation of Recurrent Tumors|
- MTD of reirradiation with the pulsed low dose rate technique [ Time Frame: Up to 30 days ] [ Designated as safety issue: Yes ]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.
- Palliative efficacy in terms of quality of life and pain levels [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]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.
- Duration of response [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]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.
- Time to progression [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves.
|Study Start Date:||November 2011|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (radiation therapy)
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.
Procedure: quality-of-life assessment
Other Name: quality of life assessmentRadiation: intensity-modulated radiation therapy
Other Name: IMRTRadiation: 3-dimensional conformal radiation therapy
Undergo 3-dimensional CRT
I. To determine the maximum tolerated dose (MTD) of reirradiation with the pulsed low dose rate technique.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470365
|United States, Pennsylvania|
|Fox Chase Cancer Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Contact: C-M Charlie Ma, PhD 215-214-1745 Charlie.Ma@fccc.edu|
|Contact: Joshua Meyer, MD 215-728-2667 email@example.com|
|Principal Investigator: C-M Charlie Ma, PhD|
|Principal Investigator: Joshua Meyer, MD|
|Principal Investigator:||C-M Charlie Ma, PhD||Fox Chase Cancer Center|
|Principal Investigator:||Josphua Meyer, MD||Fox Chase Cancer Center|