5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal... | NCT00189657

Studies
5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer

NCT00189657

Sponsor

Association Européenne de Recherche en Oncologie

Status

Unknown status

Last Update Posted

Sep 19, 2005Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Cancer of the Rectum

Interventions

5FU/LV Mayo Clinic or LV5FU2
LV5FU2 + irinotecan

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

Sep 2005

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 19, 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

Sep 12, 2005

Last Update Posted Date

Sep 19, 2005Estimated

Name	Class
Aventis Pharmaceuticals	INDUSTRY
Pfizer	INDUSTRY

Description Module

Brief Summary

The main objective of this randomized trial is to compare 5FU/LV (Mayo-Clinic regimen or LV5FU2) to LV5FU2 + irinotécan in patients with resected B2 and C rectal cancer. Preoperative radiotherapy is recommended but not mandatory. Main endpoint is disease free survival. Secondary endpoint are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 600 patients will be included in the trial.

Detailed Description

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

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

rectal adenocarcinoma
R0 surgery
T3, N0, M0 or T4, N0, M0 or N1,2, M0
chemotherapy can be started within 8 weeks after surgery
Age > 18
Performance status ECOG < 3
preoperative radiotherapy allowed
preoperative chemotherapy with 5FU +/- LV allowed
Neutrophiles > 1 500/mm3; Pl. > 100 000/mm3
Transaminases < 2 x UNL; Alcalines Phosphatases < 2 x UNL; Bili < 1.1 UNL
creatininemia < 120 µmol/l and/or clearance of creatininemia > 60 ml/mn
Written informed consent before inclusion

Exclusion Criteria:

postoperative radiotherapy
Distant metastases
Contraindication to any drug contained in the chemotherapy regimens
Any serious active disease or co-morbid medical condition including digestive inflammatory disease
Gilbert disease
severe toxicity of radiotherapy
Pregnancy or breast feeding
Absence of contraception in non menopausal women
Adult patient unable to give informed consent because of intellectual impairment
Concomitant participation to another trial

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Annie JOUHAUD	Contact	+ 33 1 43 77 72 10		annie.jouhaud@aero-eu.org

Overall Officials

Name	Affiliation	Role
Pascal Piedbois, MD	Association Europeenne de Recherche en Oncologie	Principal Investigator
Thierry Andre, MD	GERCOR - Multidisciplinary Oncology Cooperative Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AERO	Recruiting	Créteil		94000	France

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds

Name	Type	Description	Arm Group Labels	Other Names
5FU/LV Mayo Clinic or LV5FU2	Procedure
LV5FU2 + irinotecan	Procedure