Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma
Recruitment status was Active, not recruiting
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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 |
- Objective tumor response rate [ Designated as safety issue: No ]
- 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 |
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 |
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| 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 | |
| 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:
|
Adenocarcinoma Adenocarcinoma, Mucinous Colorectal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Rectal Diseases Capecitabine Fluorouracil Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013