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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

To compare patterns of failure between these two cohorts.

To compare toxicity outcomes

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

+1 more

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 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,400 Total Patients Enrolled

76 Trials studying Melanoma

15,758 Patients Enrolled for Melanoma

University of PisaOTHER

134 Previous Clinical Trials

81,676 Total Patients Enrolled

University of California, San FranciscoOTHER

2,500 Previous Clinical Trials

15,236,251 Total Patients Enrolled

11 Trials studying Melanoma

173 Patients Enrolled for Melanoma

Media Library

$IGIMRT 27 Gy in 3 fractions (Radiation) Clinical Trial Eligibility Overview. Trial Name: NCT01223248 — Phase 3$

$Melanoma Research Study Groups: stereotactic IGIMRT 27 Gy in 3 fractions, stereotactic IGIMRT using a single dose of 24 Gy$

$Melanoma Clinical Trial 2023: IGIMRT 27 Gy in 3 fractions Highlights & Side Effects. Trial Name: NCT01223248 — Phase 3$

$IGIMRT 27 Gy in 3 fractions (Radiation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01223248 — Phase 3$

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are more participants needed for this experiment?

"Unfortunately, this particular clinical trial is not currently seeking participants. Although, it is important to note that there are 1551 other medical studies that are enrolling patients."

Answered by AI

Is there a high level of danger associated with IGIMRT 27 Gy in 3 fractions?

"This IGIMRT 27 Gy in 3 fractions procedure has Phase 3 clinical trial data backing its efficacy and multiple rounds of data supporting its safety, so we estimate it to be a 3 on our Power scale."

Answered by AI

Recent research and studies

Journal of Clinical InvestigationJournal

Single-dose Radiotherapy Disables Tumor Cell Homologous Recombination via Ischemia/reperfusion Injury

Bodo, Sahra, Cécile Campagne, Tin Htwe Thin, Daniel S. Higginson, H. Alberto Vargas, Guoqiang Hua, John D. Fuller, et al.. 2019. “Single-dose Radiotherapy Disables Tumor Cell Homologous Recombination via Ischemia/reperfusion Injury”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci97631.

International Journal of Radiation Oncology*Biology*PhysicsJournal

Phase 3 Multi-center, Prospective, Randomized Trial Comparing Single-dose 24 Gy Radiation Therapy to a 3-fraction SBRT Regimen in the Treatment of Oligometastatic Cancer

Zelefsky, Michael J., Yoshiya Yamada, Carlo Greco, Eric Lis, Heiko Schöder, Stephanie Lobaugh, Zhigang Zhang, et al.. 2021. “Phase 3 Multi-center, Prospective, Randomized Trial Comparing Single-dose 24 Gy Radiation Therapy to a 3-fraction SBRT Regimen in the Treatment of Oligometastatic Cancer”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2021.01.004.

clinicaltrials.govStudy

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

2010. "Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01223248.

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