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

  Show 67 Study Locations
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 September 14, 2014