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

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

Overview[ - collapse ][ - ]

Purpose	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	Uterine Sarcoma
Intervention	Drug: doxorubicin, ifosfamide, cisplatin
Phase	Phase 3
Sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Responsible Party	Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier	NCT00162721
First Received	September 9, 2005
Last Updated	August 9, 2007
Last verified	August 2007

Tracking Information[ + expand ][ + ]

First Received Date	September 9, 2005
Last Updated Date	August 9, 2007
Start Date	September 2001
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	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
Current Secondary Outcome Measures	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

Descriptive Information[ + expand ][ + ]

Brief Title	The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
Official Title	Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Uterine Sarcoma
Intervention	Drug: doxorubicin, ifosfamide, cisplatin
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	270
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	Not Provided
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) - 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
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Patricia Pautier, Dr 33 1 42 11 4340 pautier@igr.fr
Location Countries	France

Administrative Information[ + expand ][ + ]

NCT Number	NCT00162721
Other Study ID Numbers	SARC-GYN1
Has Data Monitoring Committee	No
Information Provided By	Gustave Roussy, Cancer Campus, Grand Paris
Study Sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Collaborators	Not Provided
Investigators	Principal Investigator: Patricia Pautier, Dr Gustave Roussy, Cancer Campus, Grand Paris
Verification Date	August 2007

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