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

Gustave Roussy

Status and phase: Unknown; Phase 3

Conditions: Uterine Sarcoma

Treatments: Drug: doxorubicin, ifosfamide, cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00162721

SARC-GYN1

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)