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

Primary Purpose

Uterine Sarcoma

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
doxorubicin, ifosfamide, cisplatin
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Sarcoma focused on measuring Uterine sarcoma non metastatic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Gustave RoussyRecruiting

Outcomes

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

Full Information

First Posted
September 9, 2005
Last Updated
August 9, 2007
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00162721
Brief Title
The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
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 Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Sarcoma
Keywords
Uterine sarcoma non metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
doxorubicin, ifosfamide, cisplatin
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on overall survival
Title
Evaluation of global toxicity of the treatment in each arm

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Pautier, Dr
Phone
33 1 42 11 4340
Email
pautier@igr.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Annie Rey
Phone
33 1 42 11 4137
Email
rey@igr.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Pautier, Dr
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Pautier, Dr
Phone
33 1 42 11 4340
Email
pautier@igr.fr

12. IPD Sharing Statement

Learn more about this trial

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

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