Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas

Gustave Roussy, Cancer Campus, Grand Paris1 site in 1 country270 target enrollmentSeptember 2001

ConditionsUterine Sarcoma

Drugsdoxorubicin, ifosfamide, cisplatin

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Uterine Sarcoma
Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Enrollment: 270
Locations: 1
Primary Endpoint: 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
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2001

End Date

TBD

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Eligibility 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)

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

Outcomes

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