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

First Received: September 9, 2005 Last Updated: August 9, 2007 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Radiation Therapy Soft Tissue Sarcoma

Drug Information available for: Cisplatin Doxorubicin Doxorubicin hydrochloride Myocet Ifosfamide

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	SARC-GYN1
Study First Received:	September 9, 2005
Last Updated:	August 9, 2007
ClinicalTrials.gov Identifier:	NCT00162721 History of Changes
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:

Anti-Bacterial Agents
Neoplasms, Connective and Soft Tissue
Ifosfamide
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
Cisplatin

Uterine Sarcoma
Adjuvants, Immunologic
Sarcoma
Doxorubicin
Isophosphamide mustard

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses

Sarcoma
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin

ClinicalTrials.gov processed this record on September 11, 2009