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

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Primary Purpose

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

5FU/LV Mayo Clinic or LV5FU2

LV5FU2 + irinotecan

About this trial

This is an interventional treatment trial for Cancer of the Rectum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

AERORecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00189657

First Posted

September 12, 2005

Last Updated

September 12, 2005

Sponsor

Association Européenne de Recherche en Oncologie

Collaborators

Aventis Pharmaceuticals, Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00189657

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Association Européenne de Recherche en Oncologie

Collaborators

Aventis Pharmaceuticals, Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of the Rectum

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

5FU/LV Mayo Clinic or LV5FU2

Intervention Type

Procedure

Intervention Name(s)

LV5FU2 + irinotecan

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Annie JOUHAUD

Phone

+ 33 1 43 77 72 10

Email

annie.jouhaud@aero-eu.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pascal Piedbois, MD

Organizational Affiliation

Association Europeenne de Recherche en Oncologie

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thierry Andre, MD

Organizational Affiliation

GERCOR - Multidisciplinary Oncology Cooperative Group

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alain Piolot, MD

Organizational Affiliation

Association Europeenne de Recherche en Oncologie

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Emmanuel Achille, MD

Organizational Affiliation

GERCOR - Multidisciplinary Oncology Cooperative Group

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Iradj Bobhani, MD

Organizational Affiliation

Fondation Française de Cancérologie Digestive

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jean-Yves Douillard, MD

Organizational Affiliation

UNICANCER

Official's Role

Principal Investigator

Facility Information:

Facility Name

AERO

City

Creteil

ZIP/Postal Code

94000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pascal Piedbois, MD

Phone

+ 33 1 49 81 25 82

Email

pascal.piedbois@hmn.aphp.fr

Cancer of the Rectum

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial