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

NCT00162721 | Unknown Phase 3

• 1 other identifier: SARC-GYN1
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Sarcoma

Keywords

Uterine sarcoma non metastatic

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• 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

Interventions

doxorubicin, ifosfamide, cisplatin DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gustave Roussy, Cancer Campus, Grand Paris: lead

Study Sites (1)

Institut Gustave Roussy

Villejuif, 94800, France

RECRUITING

MeSH Terms

Interventions

Doxorubicin; Ifosfamide; Cisplatin

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Patricia Pautier, Dr

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Pautier, Dr

CONTACT

33 1 42 11 4340; pautier@igr.fr

Annie Rey

CONTACT

33 1 42 11 4137; rey@igr.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 13, 2005
• Study Start: September 1, 2001
• Last Updated: August 10, 2007

Record last verified: 2007-08

Locations

FR (1)