The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas

Phase 3

• Conditions: Uterine Sarcoma

• Registration Number: NCT00162721
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-09
• Last Update Posted: 2007-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 270

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on a 3 year event-free survival in the treatment of localized uterine sarcomas

Secondary Outcome Measures

Name	Time	Method
Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on overall survival
Evaluation of global toxicity of the treatment in each arm

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, France