Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
MelanomaOvarian CancerSarcomaBoneCNS-Spinal CD/MEMBR, NOSLymph NodesSoft Tissue
Interventions
RADIATION

IGIMRT using a single dose of 24 Gy

Pts in both the hypofractionated \& single dose arms will receive the same following standard procedures. The only difference between the arms is the dose delivered at each treatment. 20 MSKCC pts (10 per treatment arm) will be accrued to undergo baseline DW-MRI \& DCE-MRI pretreatment for both arms \& 1 hour after their initial treatment for single fraction pts, \& within one hour of their initial \& final radiation treatment for the hypofractionated pts. Pts will be considered for this scan based on compliance to scan schedule \& MRI availability for performing the scan within one hour of the planned IGRT. 24 MSKCC pts (12 per treatment arm) will be accrued for the blood collection (optional) up to 4 hours prior, 50-90 minutes after, \& approximately 24 hours \[MCPG2.3\]after treatment for single fraction pts. For pts partaking in both sub-studies, the post-treatment blood collection may be done in a 50-120 minute window to account for scheduling conflicts with the research MRI.

RADIATION

IGIMRT 27 Gy in 3 fractions

Pts in both the hypofractionated \& single dose arms will receive the same following standard procedures. The only difference between the arms is the dose delivered at each treatment. 20 MSKCC pts (10 per treatment arm) will be accrued to undergo baseline DW-MRI \& DCE-MRI pretreatment for both arms \& within 1 hour after their initial treatment for single fraction pts, \& within one hour of their initial \& final radiation treatment for the hypofractionated pts. Pts will be considered for this scan based on compliance to scan schedule \& MRI availability for performing the scan within one hour of the planned IGRT. 24 MSKCC pts (12 per treatment arm) will be accrued for the blood collection (optional) up to 4 hours prior, 50-90 minutes after, \& approximately 24 hours \[MCPG2.3\]after treatment for single fraction pts. For pts partaking in both sub-studies, the post-treatment blood collection may be done in a 50-120 minute window to account for scheduling conflicts with the research MRI.

Trial Locations (4)

10065

Memorial Sloan Kettering Cancer Center, New York

94143

University of California San Francisco, San Francisco

Unknown

University of Pisa, Pisa

The Champalimaud Centre, Lisbon

All Listed Sponsors
collaborator

University of Pisa

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

The Champalimaud Centre, Lisbon, Portugal

UNKNOWN

lead

Memorial Sloan Kettering Cancer Center

OTHER