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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02694718
Recruitment Status : Completed
First Posted : February 29, 2016
Results First Posted : November 9, 2016
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Sanofi-Synthélabo (Schweiz) AG
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
The purpose of this study is to determine the pathological complete tumor response rate.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Capecitabine Drug: Oxaliplatin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Capecitabine Plus Oxaliplatin in Combination With Pre-operative Pelvic Radiotherapy in Rectal Cancer
Study Start Date : March 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : November 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 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.
Other Name: Xeloda, Ro09-1978

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.
Other Name: Eloxatin


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Pathological Complete Tumor Response [ Time Frame: Up to Week 16 ]
    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).


Secondary Outcome Measures :
  1. Percentage of Participants With Sphincter-preservation [ Time Frame: Up to Week 16 ]
    Percentage of participants with sphincter-preservation is reported.

  2. Number of Participants With Marked Laboratory Abnormalities [ Time Frame: Up to Week 16 ]
    Number of participants with marked laboratory abnormalities is reported.

  3. Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer [ Time Frame: Up to Week 16 ]
    R0 resection was defined as complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation as confirmed by pathology after pre-operative chemotherapy plus capecitabine + oxaliplatin therapy.

  4. Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes [ Time Frame: From screening to Week 16 ]
    Downstaging of primary tumor (T) and/or lymph nodes (N) was defined as decrease by 1 point in T-value and/or N-value (comparing at screening and after treatment). It was assessed by colonoscopy, pathology, endosonography of rectum, chest X-ray, abdominopelvic Computed Tomography and Magnetic Resonance Imaging. Staging for tumor are: TX (primary tumor cannot be assessed), T0 (no evidence of primary tumor), Tis (carcinoma in situ), T1 (tumor invades submucosa), T2 (tumor invades muscularis propria), T3 (tumor invades through muscularis propria into subserosa/into non-peritonealized pericolic/perirectal tissues, T4 (tumor directly invades other organs or structures). Staging for lymph nodes are: NX (regional lymph nodes cannot be assessed), N0 (no regional lymph node metastasis), N1 (metastasis in 1 to 3 regional lymph nodes), N2 (metastasis in 4 or more regional lymph nodes).

  5. Percentage of Participants With Pathological Incomplete Tumor Response [ Time Frame: Up to Week 16 ]
    Pathological incomplete tumor response was defined as grade 1 or 2 in the histological grading of regression according to Dworak grading of regression. Pathological incomplete tumor response rate, Grade 1: dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2: dominantly fibrotic changes with few tumor cells or groups (easy to find) were assessed.

  6. Number of Participants With Any Adverse Events and Serious Adverse Events [ Time Frame: Up to Week 16 ]
    An adverse event (AE) is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02694718


Locations
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Switzerland
Basel, Switzerland, 4031
Chur, Switzerland, 7000
Luzern, Switzerland, 6004
St. Gallen, Switzerland, 9007
Zürich, Switzerland, 8037
Zürich, Switzerland, 8063
Sponsors and Collaborators
Hoffmann-La Roche
Sanofi-Synthélabo (Schweiz) AG
Investigators
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Study Chair: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02694718    
Other Study ID Numbers: ML18280
First Posted: February 29, 2016    Key Record Dates
Results First Posted: November 9, 2016
Last Update Posted: January 11, 2017
Last Verified: February 2016
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents