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

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ClinicalTrials.gov Identifier: NCT00162721
Recruitment Status : Unknown
Verified August 2007 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : September 13, 2005
Last Update Posted : August 10, 2007
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2001

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Arms and Interventions
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Outcome Measures
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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
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162721


Contacts
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Contact: Patricia Pautier, Dr 33 1 42 11 4340 pautier@igr.fr
Contact: Annie Rey 33 1 42 11 4137 rey@igr.fr

Locations
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France
Institut Gustave Roussy Recruiting
Villejuif, France, 94800
Contact: Patricia Pautier, Dr    33 1 42 11 4340    pautier@igr.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
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Principal Investigator: Patricia Pautier, Dr Gustave Roussy, Cancer Campus, Grand Paris
More Information
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ClinicalTrials.gov Identifier: NCT00162721    
Other Study ID Numbers: SARC-GYN1
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: August 10, 2007
Last Verified: August 2007
Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Uterine sarcoma non metastatic
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Ifosfamide
Antineoplastic Agents
 Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents