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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of cancer (including epithelial carcinoma, sarcoma, and melanoma) The diagnosis can be done at MSKCC or at participating institutions.

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

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

- Age 18 years or older.

- Life expectancy >3 months.

- Maximum tumor dimension of ≤6 cm in lymph nodes, soft tissue, osseous metastases, or spinal metastases seen on imaging (computed tomography [CT], magnetic resonance imaging [MRI], or PET/CT) and considered amenable for RT.

- If the lesion(s) to be treated are soft-tissue or lymph Nodes unidimensionally measurable disease is required.

Bone & spine lesions are eligible even if considered non-measurable.

- Measurable disease is defined as: - ≥ 10mm for soft-tissue lesions.

- ≥ 15mm on the short axis of lymph nodes.

- KPS ≥ 80.

- Patients must have normal bone marrow function as defined below:(within 2 months of registration) Hemoglobin ≥9.0 g/dl Absolute neutrophil count (ANC) ≥1,500/μl Platelets ≥100,000/μl.

Exclusion Criteria:

- Prior radiotherapy delivered to the target region.

- Disease to be treated on protocol is less than 2 mm from the spinal cord and therefore will not meet dose constraints* - Pregnancy or Breast-Feeding (Participants of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy).

- Chemotherapy given on the day of the planned radiotherapy treatment.

- Lesions which comprise >70% of the width of weight bearing bones, such as the femur.

- Existing cortical bone destruction, where orthopedic stabilization would be required.

- Areas to be treated on protocol do not include metastases to liver, brain or lung.

- Note: Patients with eligible and ineligible lesions will be accrued to this protocol.

Only target eligible lesions will be treated per protocol. Other eligible and ineligible lesions will be treated at the discretion of the treating physician."

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01223248
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Memorial Sloan Kettering Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yoshiya Yamada, MD
Principal Investigator Affiliation	Memorial Sloan Kettering Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Italy, Portugal, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma, Ovarian Cancer, Sarcoma, Bone, CNS-Spinal CD/MEMBR, NOS, Lymph Nodes, Soft Tissue
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: stereotactic IGIMRT using a single dose of 24 Gy

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

Experimental: stereotactic IGIMRT 27 Gy in 3 fractions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Francisco, San Francisco 5391959, California 5332921

Status

Address

University of California San Francisco

San Francisco 5391959, California 5332921, 94143

Memorial Sloan Kettering Cancer Center, New York 5128581, New York 5128638

Status

Address

Memorial Sloan Kettering Cancer Center

New York 5128581, New York 5128638, 10065

International Sites

University of Pisa, Pisa 3170647, Italy

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Address

University of Pisa

Pisa 3170647, ,

The Champalimaud Centre, Lisbon 2267057, Portugal

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Address

The Champalimaud Centre

Lisbon 2267057, ,

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