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Phase II Study of Neoadjuvant Radiotherapy and Capecitabine in Patients With Stage III or IV Colorectal Adenocarcinoma

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Treatment Closed 18 to 80 Other FRE-GERCOR-R01-01
EU-20329, NCT00075556

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.

Entry 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

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

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/mm³
Platelet count at least 100,000/mm³
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

Expected Enrollment

A total of 48 patients will be accrued for this study within 10 months.

Outcomes

Primary Outcome(s)

Objective tumor response rate

Secondary Outcome(s)

Tolerability
Rate of preservation of functional integrity of the anal sphincter
Comparison of the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation

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.

Published Results

Dupuis O, Vie B, Lledo G, et al.: Preoperative treatment combining capecitabine with radiation therapy in rectal cancer: a GERCOR Phase II Study. Oncology 73 (3-4): 169-76, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

GERCOR Groupe Cooperateur Multidisciplinaire en Oncologie

Olivier Dupuis, MD, Study coordinator
Ph: 33-2-4339-1300
Email: o.dupuis@centre-jean-bernard.org

Registry Information

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

Trial Start Date		2002-01-01

Registered in ClinicalTrials.gov		NCT00075556

Date Submitted to PDQ		2003-11-20

Information Last Verified		2008-05-29

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.