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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694718
• Other study ID #: ML18280
• Status: Completed
• Phase: Phase 2
• First received: February 25, 2016
• Last updated: February 25, 2016
• Start date: March 2005
• Est. completion date: November 2006

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swiss Agency for Therapeutic Products
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Drug:
• 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.
• Oxaliplatin
Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m^2/d on 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Sanofi-Synthélabo (Schweiz) AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with pathological complete response		Up to Week 16	No
Secondary	Percentage of participants with sphincter-preservation		Up to Week 16	No
Secondary	Number of participants with marked laboratory abnormalities		Up to Week 16	No
Secondary	Percentage of participants with Resection (R0) in participants with T4 rectal cancer		Up to Week 16	No
Secondary	Percentage of participants with downstaging of primary tumor and/or lymph nodes		Up to Week 16	No
Secondary	Percentage of participants with pathological incomplete tumor response		Up to Week 16	No
Secondary	Number of participants with adverse events		Up to Week 16	No