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

June 13, 2005
June 6, 2012
May 2006
December 2012   (final data collection date for primary outcome measure)
Disease-free survival as measured by clinical, radiological, or ultrasound exam at 3 years [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00114231 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage I Rectal Cancer
A Phase II Trial of Chemoradiotherapy and Local Excision for uT2uN0 Rectal Cancer

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: capecitabine
  • Drug: oxaliplatin
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
  • Radiation: radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
102
Not Provided
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00114231
CDR0000433145, ACOSOG-Z6041
Not Provided
David M. Ota, American College of Surgeons Oncology Group
American College of Surgeons
National Cancer Institute (NCI)
Study Chair: Julio Garcia-Aguilar, MD, PhD Beckman Research Institute
National Cancer Institute (NCI)
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP