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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Doxorubicin; Ifosfamide

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 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 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