Suspended

Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma

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What is being tested

capecitabine

+ conventional surgery
+ neoadjuvant therapy
Drug
Procedure
Radiation
Who is being recruted

Colorectal Cancer

From 18 to 80 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2002

Summary

Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: February 9, 2009
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2002Actual date on which the first participant was enrolled.

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well neoadjuvant radiation therapy and capecitabine work in treating patients who are undergoing surgery for stage III or stage IV colorectal adenocarcinoma. OBJECTIVES: Primary * Determine the objective tumor response rate in patients with stage III or IV colorectal adenocarcinoma treated with neoadjuvant radiotherapy and capecitabine. Secondary * Determine the tolerance profile of this regimen in these patients. * Determine the rate of preservation of functional integrity of the anal sphincter in patients treated with this regimen. * Compare the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily and undergo concurrent radiotherapy 5 days a week on weeks 1-5. Patients undergo surgery on week 6. Patients are followed every 4 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 10 months.

Official TitlePhase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer 
Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: February 9, 2009
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 80 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colorectal Cancer
Criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed colorectal adenocarcinoma * Clinical stage T3, T4, N+ * Measurable disease * Awaiting surgery and likely to benefit from neoadjuvant radiotherapy PATIENT CHARACTERISTICS: Age * 18 to 80 Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN * No hepatic condition that would interfere with study medication Renal * Creatinine clearance at least 80 mL/min * No renal condition that would interfere with study medication Cardiovascular * No serious cardiac failure with the past year * No myocardial infarction within the past year * No cardiac insufficiency * No angina * No uncontrolled arrhythmia * No uncontrolled hypertension Gastrointestinal * No superior intestinal tract malfunction * No malabsorption syndrome Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent serious infection * No other serious illness * No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * No metabolic condition that would interfere with study medication * No dementia or altered mental status * No psychiatric illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for colorectal cancer Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for colorectal cancer Surgery * Not specified Other * More than 30 days since prior participation in another clinical study


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 12 locations
Suspended
Centre Regional Francois BaclesseCaen, FranceSee the location
Suspended
Hopital DrevonDijon, France
Suspended
Hopital Saint - LouisLa Rochelle, France
Suspended
Centre Jean BernardLe Mans, France

Suspended12 Study Centers