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

NCT ID: NCT00075556

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31

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.

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.

Conditions

Colorectal Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

capecitabine

Intervention Type: DRUG

conventional surgery

Intervention Type: PROCEDURE

neoadjuvant therapy

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: lead

Principal Investigators

Olivier Dupuis, MD

Role:

Centre Jean Bernard

Locations

Centre Regional Francois Baclesse

Caen, , France

Hopital Drevon

Dijon, , France

Hopital Saint - Louis

La Rochelle, , France

Centre Jean Bernard

Le Mans, , France

Clinique Saint Jean

Lyon, , France

Hopital Notre-Dame de Bon Secours

Metz, , France

Intercommunal Hospital

Montfermeil, , France

Centre Hospitalier de Mulhouse

Mulhouse, , France

Hopital Saint-Louis

Paris, , France

Hopital Tenon

Paris, , France

C.H. Senlis

Senlis, , France

Centre Medico-Chirurgical Foch

Suresnes, , France

Countries

France

References

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. doi: 10.1159/000127383. Epub 2008 Apr 16.

Reference Type: RESULT

PMID: 18418009 (View on PubMed)

Other Identifiers

FRE-GERCOR-R01-01

Identifier Type: -

Identifier Source: secondary_id

EU-20329

Identifier Type: -

Identifier Source: secondary_id

CDR0000346895

Identifier Type: -

Identifier Source: org_study_id