NCT01223248

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

A Phase III Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy in Patients With Metastatic Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out which way of giving high-dose radiation works best for treatment of cancer that has spread to bone, the spine, soft tissue, or lymph nodes. This study will look at the effects, good and/or bad, of giving 27 Gy in three fractions (3 days) or 24 Gy in one fraction (1 day) using image-guided intensity-modulated radiotherapy (IG-IMRT). IG-IMRT is radiation that is given directly to the cancer site and reduces the exposure to normal tissue. Currently there are no studies that compare the effects of giving radiation in either hypofractionated doses (higher total doses of radiation spread out over several treatment days) or a single-fraction dose (entire radiation dose given in one treatment session). The patient may be asked to participate in an additional part of this study where we will get a a (DW/DCE) MRI before treatment start and within one hour after radiation treatment. If the patient is asked to take part in this portion of the study, all they will need to do is get up to 3 MRIs with standard contrast injection. The purpose of this is to see if as a result of the treatment there are changes in the blood flow going to the cancer which could suggest that the treatment may be successful. In addition some patients can present new lesions and may be asked if they would like to have these new lesions treated on the protocol. If they are given this option, this will not extend their follow up period. The follow up of the new lesions will match with the prior follow up dates.

Conditions

• Melanoma
• Ovarian Cancer
• Sarcoma
• Bone
• CNS-Spinal CD/MEMBR, NOS
• Lymph Nodes
• Soft Tissue

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2010-10-18
• Last updated: 2025-11-04

Locations

4 sites across 3 countries: United States, Italy, Portugal