The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
NCT ID: NCT00162721
Last Updated: 2007-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
270 participants
INTERVENTIONAL
2001-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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doxorubicin, ifosfamide, cisplatin
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Principal Investigators
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Patricia Pautier, Dr
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Institut Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SARC-GYN1
Identifier Type: -
Identifier Source: org_study_id