Status:
TERMINATED
Intensity-Modulated Radiation Therapy in Treating Patients Undergoing Surgery for Stage IB, Stage II, or Stage III Soft Tissue Sarcoma
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before ...
Detailed Description
OBJECTIVES: Primary * Estimate the wound complication rate in patients with stage IB-III soft tissue sarcoma (STS) treated with neoadjuvant intensity-modulated radiotherapy (IMRT). Secondary * Ass...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed soft tissue sarcoma (STS) for which neoadjuvant or adjuvant radiotherapy is considered standard care
- Stage IB-III disease
- Primary or locally recurrent disease
- The following chemotherapy-sensitive STS histologies are excluded:
- Primitive neuroectodermal tumor
- Desmoplastic small round cell tumor
- Synovial sarcoma
- Myxoid round cell liposarcoma
- Angiosarcoma
- No sarcomas for which surgical staging and adjuvant radiotherapy are considered standard care (e.g., uterine sarcomas, including leiomyosarcoma, malignant mixed Müllerian tumors, and endometrial stromal sarcoma)
- No retroperitoneal STS
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Able to complete the self-assessment questionnaires (may use translator service)
- Willing and able to undergo pre-treatment core needle biopsies
- Negative pregnancy test
- No known HIV positivity
- PRIOR CONCURRENT THERAPY:
- Prior adjuvant chemotherapy for STS allowed provided patient has locally recurrent disease
- At least 1 year since prior adjuvant chemotherapy
- No prior radiotherapy to the site of present STS
- No other concurrent cytotoxic chemotherapy, targeted therapy, or investigational agents
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00740597
Start Date
July 1 2008
End Date
April 1 2010
Last Update
July 11 2014
Active Locations (1)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000