3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Recurrent Tumors
|ClinicalTrials.gov Identifier: NCT01470365|
Recruitment Status : Active, not recruiting
First Posted : November 11, 2011
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Procedure: quality-of-life assessment Radiation: intensity-modulated radiation therapy Radiation: 3-dimensional conformal radiation therapy||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Pulsed Low Dose Rate Reirradiation Delivered With 3DCRT/IMRT for Palliation of Recurrent Tumors|
|Actual Study Start Date :||November 3, 2011|
|Actual Primary Completion Date :||August 31, 2015|
|Estimated Study Completion Date :||September 9, 2018|
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
- MTD of reirradiation with the pulsed low dose rate technique [ Time Frame: Up to 30 days ]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 ]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 ]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 ]Assessed using the RECIST 1.1 criteria. Estimated using Kaplan-Meier curves.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470365
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Principal Investigator:||C-M Charlie Ma, PhD||Fox Chase Cancer Center|
|Principal Investigator:||Josphua Meyer, MD||Fox Chase Cancer Center|