IGIMRT Dosing Schedules for Cancer Spread to Bone/Spine

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen ByYoshiya Yamada, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with Stage IV cancer that has spread to bone, spine, soft tissue, or lymph nodes. They must have a confirmed diagnosis of cancer like carcinoma, sarcoma, or melanoma and measurable disease. Participants need good physical functioning (KPS ≥ 80) and normal bone marrow function. Pregnant women or those breastfeeding are excluded.

Inclusion Criteria

Measurable disease defined as: ≥ 10mm for soft-tissue lesions, ≥ 15mm on the short axis of lymph nodes

My cancer has spread to my bones, spine, soft tissues, or lymph nodes.

My cancer is at stage IV and has spread to distant parts of my body.

+7 more

Exclusion Criteria

I have had radiation therapy on the cancer area before.

My disease is close to my spinal cord, less than 2 mm away.

I will receive chemotherapy on the same day as my radiotherapy.

+4 more

Participant Groups

The study compares two ways of delivering high-dose radiation using IG-IMRT: one group receives a single dose of 24 Gy in one day; the other gets 27 Gy across three days. The goal is to see which method is more effective for treating metastatic cancer at specific sites.

2Treatment groups

Experimental Treatment

Group I: stereotactic IGIMRT using a single dose of 24 GyExperimental Treatment1 Intervention

This is a phase III, multicenter, randomized, study comparing two dosing schedules for hypofractionated image-guided radiation therapy to bone, spine, soft tissue, and lymph nodes in patients with metastatic disease

Group II: stereotactic IGIMRT 27 Gy in 3 fractionsExperimental Treatment1 Intervention