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

Uterine Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00162721
• Other study ID #: SARC-GYN1
• Status: Recruiting
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: August 9, 2007
• Start date: September 2001

Study information

• Verified date: August 2007
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Patricia Pautier, Dr
• Phone: 33 1 42 11 4340
• Email: pautier[@]igr.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Sarcoma
• Uterine Sarcoma

Intervention

Drug:
• doxorubicin, ifosfamide, cisplatin

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on overall survival
Secondary	Evaluation of global toxicity of the treatment in each arm