Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00114231
First received: June 13, 2005
Last updated: June 6, 2012
Last verified: December 2009
  Purpose

RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Oxaliplatin may make tumor cells more sensitive to radiation therapy. Giving capecitabine and oxaliplatin together with radiation therapy before surgery may shrink the tumor so it can be removed.

PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients who are undergoing surgery for stage I rectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: capecitabine
Drug: oxaliplatin
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival as measured by clinical, radiological, or ultrasound exam at 3 years [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of resectability as measured by the pathology report at surgery [ Designated as safety issue: No ]
  • Procedure-specific morbidity and mortality rate as measured by NCI CTCAE one month after surgery [ Designated as safety issue: No ]
  • Rate of pathologic complete response of the primary tumor as measured by RECIST at surgery [ Designated as safety issue: No ]
  • Anorectal function and quality of life as measured by the fecal incontinence severity index, fecal incontinence quality of life questionnaire, and functional assessment of cancer therapy-colorectal questionnaire one year after surgery [ Designated as safety issue: No ]
  • Feasibility of using molecular studies to assess surgical resection margins and tumor response as measured by ligation detection reaction-polymerase chain reaction after surgery [ Designated as safety issue: No ]
  • Molecular markers associated with local tumor recurrence by several molecular techniques after completion of study treatment [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: May 2006
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the 3-year disease-free survival rate in patients with stage I adenocarcinoma of the rectum treated with neoadjuvant chemoradiotherapy comprising capecitabine, oxaliplatin, and radiotherapy followed by local excision.

Secondary

  • Determine the rate of resectability with negative resection margins in patients treated with this regimen.
  • Determine the procedure-specific morbidity and mortality in patients treated with this regimen.
  • Determine the rate of pathologic complete response of the primary tumor in patients treated with this regimen.
  • Determine the impact of this regimen on anorectal function and quality of life in these patients.
  • Determine the feasibility of using molecular studies to assess surgical resection margins and tumor response in patients treated with this regimen.
  • Determine molecular markers associated with local tumor recurrence in patients treated with this regimen.

OUTLINE: This is a non-randomized, multicenter study.

Patients undergo high-dose external beam radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Patients also receive oral capecitabine twice daily on days 1-14 and 22-35 and oxaliplatin IV over 2 hours on days 1, 8, 22, and 29. Approximately 4-8 weeks after completion of chemoradiotherapy, patients undergo local excision of the tumor. Patients with T3 disease or positive resection margins after local excision undergo radical resection of the rectum and receive additional chemotherapy and/or radiotherapy at the discretion of the physician.

Quality of life is assessed at baseline and then 1 year after surgery.

After completion of study treatment, patients are followed at 1 month, every 4 months for 3 years, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 102 patients will be accrued for this study within 2.8 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive adenocarcinoma of the rectum

    • T2, N0 (stage I) disease by endorectal ultrasound (ERUS) scan

      • No T1, T3, or T4 disease
      • No tumors fixed to adjacent structures by digital exam
      • Greatest tumor diameter ≤ 4 cm
      • Distal border of the tumor must be ≤ 8 cm from the anal verge by rigid proctoscopic exam
    • No positive perirectal nodes by ERUS scan
    • No histologic evidence of metastatic invasion of inguinal lymph nodes
  • No metastatic or other primary disease by chest x-ray/CT scan, abdominal and pelvic CT scan/MRI with contrast, and colonoscopy
  • No documented history of familial adenomatous polyposis
  • No documented history of hereditary non-polyposis colorectal cancer diagnosed clinically or by genetic testing

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count > 1,500/mm^3
  • Hemoglobin > 9.5 mg/dL
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • AST and ALT ≤ 2.0 times upper limit of normal (ULN)
  • Bilirubin ≤ 3 mg/dL
  • Alkaline phosphatase ≤ 2.0 times ULN

Renal

  • Creatinine clearance ≥ 50 mL/min

Cardiovascular

  • No history of New York Heart Association class III-IV congestive heart failure
  • No history of symptomatic coronary artery disease
  • No history of uncontrolled arrhythmia
  • No myocardial infarction within the past 6 months
  • No history of any other clinically significant cardiac disease

Gastrointestinal

  • No history of inflammatory bowel disease
  • No history of difficulty or inability to take or absorb oral medications

Neurologic

  • No clinically significant peripheral sensory or motor neuropathy
  • No history of uncontrolled seizures or clinically significant central nervous system disorder

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergy and/or hypersensitivity to capecitabine or oxaliplatin
  • No other malignancy within the past 5 years except curatively treated nonmelanoma skin carcinoma or in situ carcinoma
  • No history of psychiatric conditions or diminished mental capacity that would preclude study compliance or giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the pelvis
  • No concurrent intensity modulated radiotherapy

Surgery

  • Not specified

Other

  • No other concurrent investigational drugs
  • No other concurrent anticancer treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114231

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, California
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, United States, 94524-4110
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
John Muir/Mt. Diablo Comprehensive Cancer Center
Walnut Creek, California, United States, 94598
United States, Connecticut
St. Vincent's Medical Center
Bridgeport, Connecticut, United States, 06606
Praxair Cancer Center at Danbury Hospital
Danbury, Connecticut, United States, 06810
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Georgia
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
William N. Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
United States, Louisiana
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, North Dakota
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
United States, Ohio
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
CCOP - Dayton
Dayton, Ohio, United States, 45429
Grandview Hospital
Dayton, Ohio, United States, 45405
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oklahoma
Integris Oncology Services
Oklahoma City, Oklahoma, United States, 73112
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
UPMC Cancer Center at Beaver Medical Center
Beaver, Pennsylvania, United States, 15009
UPMC Cancer Center at Jefferson Regional Medical Center
Clairton, Pennsylvania, United States, 15025
UPMC Cancer Center - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
UPMC Cancer Center at the John P. Murtha Pavilion
Johnstown, Pennsylvania, United States, 15901
UPMC - Moon
Moon Township, Pennsylvania, United States, 15108
UPMC Cancer Center - Natrona Heights
Natrona Heights, Pennsylvania, United States, 15065
Jameson Memorial Hospital - North Campus
New Castle, Pennsylvania, United States, 16105
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Allegheny Cancer Center at Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
UPMC - Shadyside
Pittsburgh, Pennsylvania, United States, 15213-2582
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
UPMC Cancer Center at UPMC Passavant
Pittsburgh, Pennsylvania, United States, 15237
UPMC Cancer Center at UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
UPMC Cancer Center at UPMC St. Margaret
Pittsburgh, Pennsylvania, United States, 15215
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224-1791
St. Clair Memorial Hospital Cancer Center
Pittsburgh, Pennsylvania, United States, 15243
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
Washington Hospital Cancer Center
Washington, Pennsylvania, United States, 15301
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
Surgical Oncology Associates
Newport News, Virginia, United States, 23606
United States, Washington
Providence Cancer Center at Holy Family Hospital
Spokane, Washington, United States, 99207
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States, 99204
United States, West Virginia
United Hospital Center
Clarksburg, West Virginia, United States, 26301
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Julio Garcia-Aguilar, MD, PhD Beckman Research Institute
  More Information

Additional Information:
Publications:
Responsible Party: David M. Ota, American College of Surgeons Oncology Group
ClinicalTrials.gov Identifier: NCT00114231     History of Changes
Other Study ID Numbers: CDR0000433145, ACOSOG-Z6041
Study First Received: June 13, 2005
Last Updated: June 6, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the rectum
stage I rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Oxaliplatin
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014