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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02694718
Other study ID # ML18280
Secondary ID
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


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
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