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

NCT02694718 | Completed Phase 2 Results

• 1 other identifier: ML18280
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Pathological Complete Tumor Response

  Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response).

  Up to Week 16

Secondary Outcomes (6)

• Percentage of Participants With Sphincter-preservation

  Up to Week 16

• Number of Participants With Marked Laboratory Abnormalities

  Up to Week 16

• Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer

  Up to Week 16

• Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes

  From screening to Week 16

• Percentage of Participants With Pathological Incomplete Tumor Response

  Up to Week 16

Study Arms (1)

Capecitabine+Oxaliplatin

EXPERIMENTAL

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.

Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Capecitabine 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.

Also known as: Xeloda, Ro09-1978

Capecitabine+Oxaliplatin

Oxaliplatin 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.

Also known as: Eloxatin

Capecitabine+Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Sanofi-Synthélabo (Schweiz) AG: collaborator

Study Sites (6)

Unknown Facility

Basel, 4031, Switzerland

Location

Unknown Facility

Chur, 7000, Switzerland

Location

Unknown Facility

Lucerne, 6004, Switzerland

Location

Unknown Facility

Sankt Gallen, 9007, Switzerland

Location

Unknown Facility

Zurich, 8037, Switzerland

Location

Unknown Facility

Zurich, 8063, Switzerland

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: February 29, 2016
• Study Start: March 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: November 1, 2006
• Last Updated: January 11, 2017
• Results First Posted: November 9, 2016

Record last verified: 2016-02

Locations

CH (6)