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

Roche

Status and phase: Completed; Phase 2

Conditions: Rectal Cancer

Treatments: Drug: Oxaliplatin; Drug: Capecitabine

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02694718

ML18280

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Capecitabine+Oxaliplatin

Experimental group

Description:

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.

Treatment:

Drug: Capecitabine

Drug: Oxaliplatin