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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00162721 |
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Date of registration:
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09/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
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Scientific title:
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Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas |
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Date of first enrolment:
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September 2001 |
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Target sample size:
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270 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00162721 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Patricia Pautier, Dr |
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Address:
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Telephone:
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33 1 42 11 4340 |
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Email:
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pautier@igr.fr |
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Affiliation:
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Name:
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Patricia Pautier, Dr |
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Address:
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Telephone:
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33 1 42 11 4340 |
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Email:
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pautier@igr.fr |
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Affiliation:
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Name:
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Patricia Pautier, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gustave Roussy, Cancer Campus, Grand Paris |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Uterine Sarcoma
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Intervention(s)
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Drug: doxorubicin, ifosfamide, cisplatin
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on overall survival
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Evaluation of global toxicity of the treatment in each arm
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Secondary ID(s)
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SARC-GYN1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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