Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas

Condition	Intervention	Phase
Uterine Sarcoma Non Metastatic	Drug: doxorubicine, ifosfamide, cisplatinum	Phase III

Further Study Details: 

Primary Outcomes: 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 Outcomes: 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
Expected Total Enrollment:  270

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Female

Criteria

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 exaeresis5- Age ³ 18 years and physiological age £ 65 years
• Negative extension check-up (thoracic and abdomino-pelvic TDM)
• PS £ 2
• Normal haematologic functions (absolute neutrophil conts > 1500/mm3, platelets > 100 000/mm3)
• Serum creatinine < 1,25 x N
• Good hepatic check-up (total serum bilirubin < 1.5 x N ; AST or ALT < 2.5 x N)
• Absence of neuropathy > grade 1
• Left ventricular ejection fraction >50% (by isotopic or ultrasound scan determination)
• Written informed consent

Exclusion Criteria:

• Low grade endometrial stromal sarcoma
• Time since surgery > 8 weeks
• Specific contra-indications 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 baso-cellular one or an in situ épithelioma of cervix

Please refer to this study by ClinicalTrials.gov identifier  NCT00162721

Patricia PAUTIER, Dr      33 1 42 11 4340    pautier@igr.fr
Annie REY      33 1 42 114137    rey@igr.fr

France
      Institut Gustave Roussy, Villejuif,  94800,  France; Recruiting

Study chairs or principal investigators

Patricia PAUTIER, Dr,  Principal Investigator,  Insitut Gustave Roussy   

Study ID Numbers:  SARC-GYN1
Last Updated:  September 12, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00162721
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13