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Radiation

IGIMRT Dosing Schedules for Cancer Spread to Bone/Spine

Phase 3

Waitlist Available

Led By Yoshiya Yamada, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Sites of metastatic disease to be treated on protocol limited to bone, spine, soft tissue, and lymph nodes

Patients with American Joint Committee on Cancer (6th edition, 2002) Stage IV cancer with distant metastases

Must not have

Prior radiotherapy to the target region

Disease to be treated on protocol less than 2 mm from the spinal cord

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying two ways of giving high-dose radiation for treatment of cancer that has spread to bone, the spine, soft tissue, or lymph nodes. One way is 27 Gy in three fractions (3 days) and the other is 24 Gy in one fraction (1 day).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include skin reactions at the treatment site, fatigue due to radiation exposure, possible acute pain flare-ups post-treatment in treated areas, and general discomfort associated with MRI procedures if applicable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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My cancer diagnosis was confirmed through lab tests at a participating institution.

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I am 18 years old or older.

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My largest cancer spot is 6 cm or smaller and can be treated with radiation.

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My blood tests from the last 2 months show normal bone marrow function.

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I can carry out normal activities with minimal assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy on the cancer area before.

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

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

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My cancer has spread to more than 70% of a major bone.

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I need surgery to stabilize my bones due to damage.

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My cancer has not spread to my liver, brain, or lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To compare the loco-regional control rates of two established hypo-fractionated radiation treatment regimens

Secondary study objectives

To look at changes in SUV uptake as a measure of tumor response.

changes in tumor perfusion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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

0 / 13Eligibility criteria met