Status:
UNKNOWN
The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Uterine Sarcoma
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief Summary
This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas.
Eligibility Criteria
Inclusion
- Histologically confirmed uterine sarcoma (rereading in reference centers)
- Leiomyosarcoma, adenosarcoma, carcinosarcoma and high grade endometrial stromal sarcoma
- All stages \<= stage III (FIGO modified for endometrial carcinoma)
- Full surgical exeresis
- Age \>= 18 years and physiological age \<= 65 years
- Negative extension check-up (thoracic and abdomino-pelvic TDM)
- Performance status (PS) \<= 2 (ECOG)
- Normal haematologic functions (absolute neutrophil count \> 1,500/mm3, platelets \> 100,000/mm3)
- Serum creatinine \< 1.25 x ULN
- Good hepatic check-up (total serum bilirubin \< 1.5 x ULN; AST or ALT \< 2.5 x ULN)
- Absence of neuropathy \> grade 1
- Left ventricular ejection fraction \> 50% (by isotopic or ultrasound scan determination)
- Written informed consent
Exclusion
- Low grade endometrial stromal sarcoma
- Time since surgery \> 8 weeks
- Specific contraindications to the studied treatment (cardiac, kidney, or hepatic ones)
- Antecedents or evolutive psychiatric disorder
- Concurrent active infection or other serious uncontrolled systemic disease
- Antecedents of cancer but a cutaneous basocellular one or an in situ epithelioma of the cervix
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00162721
Start Date
September 1 2001
Last Update
August 10 2007
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94800