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

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. Identifier: NCT00075556
Recruitment Status : Unknown
Verified May 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2004
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: capecitabine Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 2

Detailed Description:



  • Determine the objective tumor response rate in patients with stage III or IV colorectal adenocarcinoma treated with neoadjuvant radiotherapy and capecitabine.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer
Study Start Date : January 2002

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Objective tumor response rate

Secondary Outcome Measures :
  1. Tolerability
  2. Rate of preservation of functional integrity of the anal sphincter
  3. Comparison of the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed colorectal adenocarcinoma

    • Clinical stage T3, T4, N+
  • Measurable disease
  • Awaiting surgery and likely to benefit from neoadjuvant radiotherapy



  • 18 to 80

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • 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


  • Creatinine clearance at least 80 mL/min
  • No renal condition that would interfere with study medication


  • 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


  • No superior intestinal tract malfunction
  • No malabsorption syndrome


  • 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


Biologic therapy

  • Not specified


  • No prior chemotherapy for colorectal cancer

Endocrine therapy

  • Not specified


  • No prior radiotherapy for colorectal cancer


  • Not specified


  • More than 30 days since prior participation in another clinical study

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 identifier (NCT number): NCT00075556

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Centre Regional Francois Baclesse
Caen, France, 14076
Hopital Drevon
Dijon, France, 21000
Hopital Saint - Louis
La Rochelle, France, 17000
Centre Jean Bernard
Le Mans, France, 72000
Clinique Saint Jean
Lyon, France, 69008
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Intercommunal Hospital
Montfermeil, France, 93370
Centre Hospitalier de Mulhouse
Mulhouse, France, 68051
Hopital Saint-Louis
Paris, France, 75475
Hopital Tenon
Paris, France, 75970
C.H. Senlis
Senlis, France, 60309
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
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OverallOfficial: Olivier Dupuis, MD Centre Jean Bernard
Publications of Results:
Layout table for additonal information Identifier: NCT00075556    
Other Study ID Numbers: CDR0000346895
First Posted: January 12, 2004    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: May 2008
Keywords provided by National Cancer Institute (NCI):
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
adenocarcinoma of the rectum
adenocarcinoma of the colon
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents