Suspended

Phase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer

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What is being tested

Data Collection

Who is being recruted

Adenocarcinoma+12

+ Carcinoma

+ Colonic Diseases

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2002
See protocol details

Summary

Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2002

Actual date on which the first participant was enrolled.

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 
NCT00075556
Principal SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
Last updated: January 14, 2026
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.

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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaColonic DiseasesDigestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsIntestinal DiseasesIntestinal NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialRectal DiseasesColorectal Neoplasms

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 Baclesse

Caen, FranceSee the location
Suspended

Hopital Drevon

Dijon, France
Suspended

Hopital Saint - Louis

La Rochelle, France
Suspended

Centre Jean Bernard

Le Mans, France
Suspended12 Study Centers