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NCT Number: NCT00796718

A Study of Xeloda (Capecitabine) Plus Radiotherapy in Participants With Locally Advanced Rectal Cancer

This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible participants will receive Xeloda 825mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated time on study treatment is < 3 months, and the target sample size is < 100 individuals.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Banská Bystrica, Slovakia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients, 18-80 years of age;
  • rectal cancer;
  • planned surgery, and likely to benefit from pre-operative combined chemo-radiotherapy;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion criteria

  • previous radiotherapy or chemotherapy for colorectal cancer;
  • clinically significant cardiovascular disease;
  • significant gastric or small intestine disease;
  • serious uncontrolled active infection

Treatment and study plan

Standard radiotherapy

Radiation

Administered as prescribed according to normal clinical practice.

capecitabine [Xeloda]

Drug

825 milligrams per meter square (mg/m^2) orally twice daily for 5 weeks.

Other names: Xeloda®

Primary outcomes

  1. Percentage of Participants With Pathological Complete Response

    Time frame: Up to 11 weeks (assessed at the time of post-treatment surgery)

    Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures.

Secondary outcomes

  1. Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment)

    Time frame: Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy)

    Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.

  2. Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment)

    Time frame: Up to 15 weeks (assessed 1 month after surgery)

    Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD.

  3. Percentage of Participants With Adverse Events

    Time frame: Up to 15 weeks

    An adverse event was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open Label Study of the Effect of Xeloda and Radiotherapy on Pathological Response Rate in Patients With Locally Advanced Rectal Cancer

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 24, 2008
Registry last updated
Aug 25, 2016

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

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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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