A Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer

NCT ID: NCT02694718

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2006-11-30

Brief Summary

The purpose of this study is to determine the pathological complete tumor response rate.

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capecitabine+Oxaliplatin

Eligible participants received capecitabine 1000 milligrams per square meter (mg/m\^2) on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

Capecitabine is available as 50 mg and 500 mg tablets. It will be administered as a 1000mg/m\^2 bid orally on Days 1-14, and at a dose of 825mg/m\^2 bid on Days 22-35 and 43-56.

Oxaliplatin

Intervention Type: DRUG

Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m\^2/d intravenously on Day 1 and 50mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy up to Week 9 followed by surgery period.

Interventions

Capecitabine

Capecitabine is available as 50 mg and 500 mg tablets. It will be administered as a 1000mg/m\^2 bid orally on Days 1-14, and at a dose of 825mg/m\^2 bid on Days 22-35 and 43-56.

Intervention Type: DRUG

Oxaliplatin

Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m\^2/d intravenously on Day 1 and 50mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy up to Week 9 followed by surgery period.

Intervention Type: DRUG

Other Intervention Names

Xeloda, Ro09-1978; Eloxatin

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed locally advanced T3/T4 rectal carcinoma with or without nodal involvement requiring surgery of the primary tumor
• Eastern Cooperative Oncology Group performance status 0-2
• Adequate values of laboratory parameters

Exclusion Criteria

• Evidence of distant metastases
• Previous Chemotherapy or immunotherapy for colorectal cancer
• Previous radiotherapy to the pelvis
• Pre-existing condition which would deter radiotherapy
• Malignancy within last 5 years, except cured basal cell cancer of the skin and in situ cancer of the cervix
• Clinically significant cardiac disease or myocardial infarction within the last 12 months
• Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome
• Organ allografts
• Concomitant treatment with brivudine, lamivudine, ribavirin or any other nucleoside analogues
• Dihydropyrimidine dehydrogenase (DPD) deficiency
• History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent or interfering with compliance for oral drug intake

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi-Synthélabo (Schweiz) AG

UNKNOWN

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Basel, , Switzerland

Chur, , Switzerland

Lucerne, , Switzerland

Sankt Gallen, , Switzerland

Zurich, , Switzerland

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

ML18280

Identifier Type: -

Identifier Source: org_study_id