Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma - Full Text View

Sponsored by:	Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075556

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 II

MedlinePlus related topics: Cancer Colorectal Cancer Radiation Therapy Surgery

Drug Information available for: Capecitabine

U.S. FDA Resources

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

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

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

Locations

France
C.H. Senlis
Senlis, France, 60309
Centre Hospitalier de Mulhouse
Mulhouse, France, 68051
Centre Jean Bernard
Le Mans, France, 72000
Centre Medico-Chirurgical Foch
Suresnes, France, 92151
Centre Regional Francois Baclesse
Caen, France, 14076
Clinique Saint Jean
Lyon, France, 69008
Intercommunal Hospital
Montfermeil, France, 93370
Hopital Notre-Dame de Bon Secours
Metz, France, 57038
Hopital Saint - Louis
La Rochelle, France, 17000
Hopital Saint-Louis
Paris, France, 75475
Hopital Tenon
Paris, France, 75970
Hopital Drevon
Dijon, France, 21000

Sponsors and Collaborators

Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Investigators

Investigator:

Olivier Dupuis, MD

Centre Jean Bernard

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Dupuis O, Vie B, Lledo G, Hennequin C, Noirclerc M, Bennamoun M, Jacob JH. Preoperative treatment combining capecitabine with radiation therapy in rectal cancer: a GERCOR Phase II Study. Oncology. 2007;73(3-4):169-76. Epub 2008 Apr 16.

Study ID Numbers:	CDR0000346895, FRE-GERCOR-R01-01, EU-20329
Study First Received:	January 9, 2004
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00075556 History of Changes
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

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Carcinoma
Rectal Cancer
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Antimetabolites
Capecitabine
Antimetabolites, Antineoplastic
Neoplasms by Histologic Type
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

Pharmacologic Actions
Intestinal Neoplasms
Carcinoma
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009