The Addition of Polychemotherapy to Adjuvant Radiotherapy... | NCT00162721

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

NCT00162721

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Unknown status

Last Update Posted

Aug 10, 2007Estimated

Enrollment

270Estimated

Phase

Phase 3

Conditions

Uterine Sarcoma

Interventions

doxorubicin, ifosfamide, cisplatin

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2001

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2007

Last Update Posted Date

Aug 10, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

270Estimated

Name	Type	Description	Arm Group Labels	Other Names
doxorubicin, ifosfamide, cisplatin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patricia Pautier, Dr	Contact	33 1 42 11 4340		pautier@igr.fr
Annie Rey	Contact	33 1 42 11 4137		rey@igr.fr

Overall Officials

Name	Affiliation	Role
Patricia Pautier, Dr	Gustave Roussy, Cancer Campus, Grand Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave Roussy	Recruiting	Villejuif		94800	France

Intervention Browse Module

MeSH Terms

ID	Term
D004317	Doxorubicin
D007069	Ifosfamide
D002945	Cisplatin

Ancestor Terms

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided