Status:
ACTIVE_NOT_RECRUITING
Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
University of Pisa
University of California, San Francisco
Conditions:
Melanoma
Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 loo...
Eligibility Criteria
Inclusion
- 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
- 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."
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01223248
Start Date
October 1 2010
End Date
October 1 2026
Last Update
November 4 2025
Active Locations (4)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
3
University of Pisa
Pisa, Italy
4
The Champalimaud Centre
Lisbon, Portugal