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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT00162721
First received: September 9, 2005
Last updated: August 9, 2007
Last verified: August 2007
  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 Intervention Phase
Uterine Sarcoma
Drug: doxorubicin, ifosfamide, cisplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Gustave Roussy, Cancer Campus, Grand Paris:

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

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

Estimated Enrollment: 270
Study Start Date: September 2001
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00162721

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

Locations
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
Principal Investigator: Patricia Pautier, Dr Gustave Roussy, Cancer Campus, Grand Paris
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00162721     History of Changes
Other Study ID Numbers: SARC-GYN1
Study First Received: September 9, 2005
Last Updated: August 9, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Gustave Roussy, Cancer Campus, Grand Paris:
Uterine sarcoma non metastatic

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Cisplatin
Doxorubicin
Ifosfamide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014