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

This study is currently recruiting participants.
Verified by Institut Gustave Roussy, August 2007

Sponsored by: Institut Gustave Roussy
Information provided by: Institut Gustave Roussy
ClinicalTrials.gov Identifier: NCT00162721
  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 III

MedlinePlus related topics:   Soft Tissue Sarcoma   

ChemIDplus related topics:   Doxorubicin    Doxorubicin hydrochloride    Ifosfamide    Cisplatin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas

Further study details as provided by Institut Gustave Roussy:

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

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
Institut Gustave Roussy

Investigators
Principal Investigator:     Patricia Pautier, Dr     Institut Gustave Roussy    
  More Information


Study ID Numbers:   SARC-GYN1
First Received:   September 9, 2005
Last Updated:   August 9, 2007
ClinicalTrials.gov Identifier:   NCT00162721
Health Authority:   France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Gustave Roussy:
Uterine sarcoma non metastatic  

Study placed in the following topic categories:
Neoplasms, Connective and Soft Tissue
Ifosfamide
Cisplatin
Malignant mesenchymal tumor
Sarcoma
Uterine sarcoma
Doxorubicin
Soft tissue sarcomas
Isophosphamide mustard

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008




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