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

G

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)

Trial contacts and locations

1

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Central trial contact

Annie Rey; Patricia Pautier, Dr

Data sourced from clinicaltrials.gov

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