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The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Active
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18 to 65
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Other
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SARC-GYN1
NCT00162721
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Trial Description
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. 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)
- 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)
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
Trial Contact Information
Trial Lead Organizations/Sponsors Institut Gustave Roussy | Patricia Pautier, Dr | | Principal Investigator |
Trial Sites
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| France |
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Villejuif |
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| | | | | | | | Institut Gustave Roussy |
| | | Patricia Pautier, Dr |
Ph: 33 1 42 11 4340 |
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Email:
pautier@igr.fr |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00162721
Information obtained from ClinicalTrials.gov on May 27, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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