Xeloda or UFT (Tegafur-uracil) With Folinic Acid in Advanced or Metastatic Colorectal Cancer (COLOCROSS)

Centre Oscar Lambret

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: XELODA; Drug: TEGAFUR URACIL - FOLINIC ACID

Study type: Interventional

Funder types: Other

Identifiers

NCT00905047

COLOCROSS

Details and patient eligibility

About

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.

Full description

Further study details as provided by Centre Oscar Lambret.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

89 participants in 2 patient groups

XELODA

Other group

Treatment:

Drug: XELODA

UFT

Other group

Treatment:

Drug: TEGAFUR URACIL - FOLINIC ACID