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

NCT00189657

Last updated date
Study Location
AERO
Creteil, , 94000, France
Contact
+ 33 1 43 77 72 10

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cancer of the Rectum
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Cancer of the Rectum5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer
NCT00189657
  1. Creteil,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE 5FU/VL Vs LV5FU2 + CPT11 in Stage II-III Resected Rectal Cancer
Official Title  ICMJE Not Provided
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer of the Rectum
Intervention  ICMJE
  • Procedure: 5FU/LV Mayo Clinic or LV5FU2
  • Procedure: LV5FU2 + irinotecan
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00189657
Other Study ID Numbers  ICMJE AERO-R98
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Association Européenne de Recherche en Oncologie
Collaborators  ICMJE
  • Aventis Pharmaceuticals
  • Pfizer
Investigators  ICMJE
Principal Investigator:Pascal Piedbois, MDAssociation Europeenne de Recherche en Oncologie
Principal Investigator:Thierry Andre, MDGERCOR - Multidisciplinary Oncology Cooperative Group
Principal Investigator:Alain Piolot, MDAssociation Europeenne de Recherche en Oncologie
Principal Investigator:Emmanuel Achille, MDGERCOR - Multidisciplinary Oncology Cooperative Group
Principal Investigator:Iradj Bobhani, MDFondation Française de Cancérologie Digestive
Principal Investigator:Jean-Yves Douillard, MDUNICANCER
PRS Account Association Européenne de Recherche en Oncologie
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP