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


Phase 3
18 Years
65 Years
Open (Enrolling)
Female
Uterine Sarcoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Patricia Pautier, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

SARC-GYN1

NCT ID:

NCT00162721

Start Date:

September 2001

Completion Date:

Related Keywords:

  • Uterine Sarcoma
  • Uterine sarcoma non metastatic
  • Sarcoma

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