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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00075556
First received: January 9, 2004
Last updated: February 6, 2009
Last verified: May 2008
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: capecitabine
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective tumor response rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability [ Designated as safety issue: Yes ]
  • Rate of preservation of functional integrity of the anal sphincter [ Designated as safety issue: No ]
  • Comparison of the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation [ Designated as safety issue: No ]

Study Start Date: January 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075556

Locations
France
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
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Investigator: Olivier Dupuis, MD Centre Jean Bernard
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00075556     History of Changes
Other Study ID Numbers: CDR0000346895, FRE-GERCOR-R01-01, EU-20329
Study First Received: January 9, 2004
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

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:
Colorectal Neoplasms
Adenocarcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014