Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer (COLOCROSS)
This study has been completed.
Sponsor:
Centre Oscar Lambret
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00905047
First received: May 18, 2009
Last updated: July 20, 2012
Last verified: July 2012
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Purpose
The scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments.
Another objective of the trial is to assess and compare the safety of each treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: XELODA Drug: TEGAFUR URACIL - FOLINIC ACID |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open Comparative Study With a Cross-over According to Patients'Preference Receiving Xeloda or UFT With Folinic Acid in Advanced or Metastatic Colo-rectal Cancer |
Resource links provided by NLM:
Further study details as provided by Centre Oscar Lambret:
Primary Outcome Measures:
- patients preference after randomization and cross-over [ Time Frame: after 2 cycles of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- safety of each treatment [ Time Frame: at day 56 (after two cycles of treatment) ] [ Designated as safety issue: Yes ]
| Enrollment: | 89 |
| Study Start Date: | September 2005 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| XELODA |
Drug: XELODA
XELODA, 2500 mg/m²/bid, with approximatively an interval of 12 hours, 30 minutes after breakfast and dinner - during 14 days. Cycle treatment duration : 21 days |
| UFT |
Drug: TEGAFUR URACIL - FOLINIC ACID
Tegafur 300 mg/m2/tid with folinic acid 75 mg/tid during 28 days. Duration of treatment cycle : 35 days. |
Detailed Description:
Further study details as provided by Centre Oscar Lambret.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Locally advanced or metastatic colo-rectal cancer
- Age > or = 18 years old
- PS-WHO < or = 2
- Polynuclear neutrophil leukocytes > or = 1500/mm3, platelets > or = 100000/mm3
- Total bilirubin < or = 3 ULN, ASAT-ALAT < or = 2.5 ULN
- Effective contraception
- Written informed consent signed
Exclusion Criteria:
- Concomitant radiotherapy
- Contraindication to fluoropyrimidines
- Treatment with sorivudine and its chemical analogs such as brivudine
- Severe hepatic insufficiency
- Severe renal insufficiency
- Pregnant or lactating woman
- Hypersensitivity to capecitabine, 5FU, tegafur or one of its excipients
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905047
Locations
| France | |
| Centre Paul Papin | |
| Angers, France, 49033 | |
| Centre Hospitalier | |
| Armentieres, France, 59280 | |
| Centre Hospitalier de Béthune | |
| Beuvry, France, 62660 | |
| Centre Hospitalier de CHOLET | |
| Cholet, France, 49300 | |
| Centre Leonard de Vinci | |
| Dechy, France, 59187 | |
| Polyclinique du Bois | |
| Lille, France, 59000 | |
| Centre Hospitalier Regional | |
| Lille, France, 59035 | |
| Centre Oscar Lambret | |
| Lille, France, 59020 | |
| Hopital Saint Vincent de Paul | |
| Lille, France, 59020 | |
| Centre Hospitalier | |
| Roubaix, France, 59100 | |
| Centre Joliot-Curie | |
| Saint Martin les Boulogne, France, 62280 | |
| Centre Hospitalier | |
| Valenciennes, France, 59300 | |
| Clinique des Dentellieres | |
| Valenciennes, France, 59300 | |
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
| Principal Investigator: | ADENIS Antoine, MD,PhD | Centre Oscar Lambret |
More Information
No publications provided
| Responsible Party: | Centre Oscar Lambret |
| ClinicalTrials.gov Identifier: | NCT00905047 History of Changes |
| Other Study ID Numbers: | COLOCROSS |
| Study First Received: | May 18, 2009 |
| Last Updated: | July 20, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Oscar Lambret:
|
colo-rectal cancer advanced metastatic locally advanced or metastatic colo-rectal cancer |
Additional relevant MeSH terms:
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Colonic Diseases Tegafur Capecitabine Leucovorin |
Folic Acid Levoleucovorin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Antidotes Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013