Status:
COMPLETED
A Prospective Randomized Trial of Pre-Operative IMRT+Surgery Versus Surgery Alone For Primary Retroperitoneal Sarcoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a phase III clinical trial for patients with potentially completely resectable primary retroperitoneal sarcoma. Patients who take part will be divided into two groups, a radiation therapy plus...
Detailed Description
Primary Objective: To ascertain whether patients with completely resected (R0 + R1), primary retroperitoneal sarcoma who are randomized to pre-operative IMRT and surgery have a longer recurrence-free ...
Eligibility Criteria
Inclusion
- Patients with primary retroperitoneal/pelvic soft tissue sarcoma.
- Gross total resection (RO or R1) must be feasible.
- No prior chemotherapy, immunotherapy or radiotherapy is allowable.
- Patients should be over 18 years of age and capable of providing informed consent indicating awareness of the investigational nature of this trial, in keeping with hospital policy.
- Karnofsky performance status of \>= 70 %
- No other concurrent chemotherapy, immunotherapy or radiotherapy is allowable.
- Adequate organ function defined as follows: absolute granulocytes \>= 1,500/mm 3, platelets \>= 150,000/mm 3, serum bilirubin \<= 1.5 mg/dl, serum creatinine \<= 1.5 mg/dl.
- Written informed consent (study specific) must be obtained from each patient prior to entering the study.
- Patients should be willing to be followed at Memorial Sloan-Kettering Cancer Center during the course of treatment and follow-up.
- Patients must be able to get IMRT radiotherapy at Memorial Sloan-Kettering Cancer Center
Exclusion
- Patients presenting with primary non-retroperitoneal soft tissue sarcoma or recurrent retroperitoneal sarcoma.
- Patients who are deemed unresectable by clinical/imaging criteria.
- Patients with histologic diagnosis of gastrointestinal stromal sarcoma, desmoplastic small round cell tumor, desmoid, Ewing's sarcoma, PNET, adenosarcoma, granular cell tumor, mesothelioma or rhabdomyosarcoma are excluded from the study.
- Patients with known metastatic disease, or those with radiologically evident metastases.
- Patients with clinically significant heart disease (NYHA Class III/IV), history of active angina or myocardial infarction within 6 months, history of significant ventricular arrhythmia requiring medication with antiarrhythmics or a history of clinically significant conduction system abnormality. Patients with any of the above conditions who are seen by a cardiologist at MSKCC and are found to be an acceptable risk for surgery will be allowed to participate in this study.
- Patients with any active concurrent malignancy other than non-melanoma skin cancers or carcinoma-in situ of the cervix. Patients with previous malignancies but without evidence of disease for \> 5 years will be eligible.
- Women who are pregnant.
- Patients currently participating in other clinical trials the requirements of which may preclude their complete involvement in this study
- Patients with serious intercurrent infections or non-malignant uncontrolled illnesses
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00131898
Start Date
May 1 2003
End Date
September 1 2005
Last Update
December 23 2008
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021