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

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
capecitabine
conventional surgery
neoadjuvant therapy
radiation therapy
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, adenocarcinoma of the rectum, adenocarcinoma of the colon

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Regional Francois Baclesse
  • Hopital Drevon
  • Hopital Saint - Louis
  • Centre Jean Bernard
  • Clinique Saint Jean
  • Hopital Notre-Dame de Bon Secours
  • Intercommunal Hospital
  • Centre Hospitalier de Mulhouse
  • Hopital Saint-Louis
  • Hopital Tenon
  • C.H. Senlis
  • Centre Medico-Chirurgical Foch

Outcomes

Primary Outcome Measures

Objective tumor response rate

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2004
Last Updated
February 6, 2009
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00075556
Brief Title
Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma
Official Title
Phase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage III colon cancer, stage IV colon cancer, stage III rectal cancer, stage IV rectal cancer, adenocarcinoma of the rectum, adenocarcinoma of the colon

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Objective tumor response rate
Secondary Outcome Measure Information:
Title
Tolerability
Title
Rate of preservation of functional integrity of the anal sphincter
Title
Comparison of the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Dupuis, MD
Organizational Affiliation
Centre Jean Bernard
Facility Information:
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Hopital Drevon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hopital Saint - Louis
City
La Rochelle
ZIP/Postal Code
17000
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Clinique Saint Jean
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Hopital Notre-Dame de Bon Secours
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
Intercommunal Hospital
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
ZIP/Postal Code
68051
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
C.H. Senlis
City
Senlis
ZIP/Postal Code
60309
Country
France
Facility Name
Centre Medico-Chirurgical Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
18418009
Citation
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.
Results Reference
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Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma

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