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Completed

NCT Number: NCT02694718

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Basel, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Xeloda, Ro09-1978

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.

Other names: Eloxatin

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Collaborators

  • Sanofi-Synthélabo (Schweiz) AG

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Feb 29, 2016
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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