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

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00162721
• Collaborator: (none)
• Enrollment: 270
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Sarcoma	Drug: doxorubicin, ifosfamide, cisplatin	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 270 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
• Study Start Date: Sep 1, 2001

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on overall survival []

2. Evaluation of global toxicity of the treatment in each arm []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Gustave Roussy	Villejuif		France	94800

Sponsors and Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris

Investigators

• Principal Investigator: Patricia Pautier, Dr, Gustave Roussy, Cancer Campus, Grand Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00162721
• Other Study ID Numbers: SARC-GYN1
• First Posted: Sep 13, 2005
• Last Update Posted: Aug 10, 2007
• Last Verified: Aug 1, 2007

• Keywords provided by , ,: Uterine sarcoma non metastatic
• Additional relevant MeSH terms: Sarcoma; Doxorubicin; Ifosfamide

Study Results

No Results Posted as of Aug 10, 2007