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Combination Chemotherapy in Treating Patients Undergoing Surgery for Rectal Cancer

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ClinicalTrials.gov Identifier: NCT00831181
Recruitment Status : Unknown
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : January 28, 2009
Last Update Posted : June 17, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may kill more tumor cells and may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving oxaliplatin, leucovorin, and fluorouracil after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy works in treating patients undergoing surgery for rectal cancer.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: FOLFOX regimen Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: quality-of-life assessment Procedure: therapeutic surgical procedure Phase 2

Detailed Description:



  • To assess the complete pathologic response rate in patients with rectal cancer treated with modified neoadjuvant FOLFOX 6 chemotherapy followed by total mesorectal excision and adjuvant modified FOLFOX 6 chemotherapy.


  • To observe the overall pathologic response rate in these patients.
  • To correlate pathologic staging with preoperative ultrasound and pelvic MRI staging.
  • To assess toxic side effects of these regimens in these patients.
  • To assess patterns of disease relapse, disease-free survival outcomes, and overall survival outcomes of these patients.


  • Neoadjuvant therapy: Patients receive modified FOLFOX 6 chemotherapy comprising oxaliplatin and leucovorin calcium IV over 2 hours on day 1 and continuous fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to surgery.
  • Surgery: Patients undergo total mesorectal excision by anterior resection or an abdominal perineal resection within 4 weeks after completion of neoadjuvant therapy.
  • Adjuvant therapy: Within 4 weeks after surgery, patients receive modified FOLFOX 6 chemotherapy comprising oxaliplatin and leucovorin calcium IV over 2 hours on day 1 and continuous fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Patients complete quality of life assessment questionnaires at baseline and at each follow-up visit.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open- Labeled, Prospective Study to Determine the Efficacy of Pre- Operative Chemotherapy With Six Cycles of Modified FOLFOX 6 Followed by Total Mesorectal Excision (TME) Followed by an Additional Six Cycles of FOLFOX 6
Study Start Date : January 2009
Estimated Primary Completion Date : January 2012

Primary Outcome Measures :
  1. Pathologic response and complete response rate

Secondary Outcome Measures :
  1. Toxicity
  2. Locoregional control
  3. Complete resectability rates
  4. Ability of high resolution pelvic MRI to assess locoregional response and predict adequacy of the circumferential margin after total mesorectal excision (TME)
  5. Sphincter preservation
  6. Disease-free survival
  7. Overall survival
  8. Preservation of sexual, urinary, and bowel function
  9. Patterns of disease failure, including local recurrence and distant metastasis assessed by CT scan
  10. Quality of life at baseline and annually following TME
  11. Comparison of preoperative stage with post-treatment pathologic stage
  12. Comparison of preoperative staging with pelvic MRI vs endorectal ultrasound

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the rectum

    • T3, N0, M0 or T1-3, N1, M0 disease as assessed by clinical exam, transrectal ultrasound, MRI, and CT scan

      • No preoperative evidence of T4, N2 or distal lesions (0-6 cm from anal verge)
    • Distal border of the tumor must be ≥ 6 cm from the anal verge on preoperative proctoscopy with the patient in the left lateral decubitus position
    • Proximal border of the tumor must be ≤ 12 cm of the anal verge by proctoscopic examination
  • No known or distant metastases
  • No positive circumferential margin


  • Karnofsky performance status (PS) 60-100% or ECOG PS 0-1
  • ANC ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 times ULN
  • ALT ≤ 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness or social situations that would limit compliance with study requirements
  • No serious comorbid disease, including psychiatric disorders and cardiopulmonary disease which precludes full delivery of study treatment
  • No other cancer diagnosis within the past 5 years, except nonmelanomatous skin cancers or in situ carcinoma of the cervix
  • No history of clinically significant peripheral neuropathy or current symptoms of neuropathy, defined as ≥ grade 2 neurosensory or neuromotor toxicity
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to fluorouracil, oxaliplatin, or leucovorin calcium
  • No HIV positivity


  • No prior chemotherapy or pelvic irradiation
  • No other concurrent investigational agents
  • No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No concurrent halogenated antiviral agents (e.g., sorivudine or brivudine)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00831181

United States, New York
Beth Israel Medical Center - Philipps Ambulatory Care Center Recruiting
New York, New York, United States, 10003
Contact: Clinical Trials Office - Beth Israel Medical Center - Philipps    212-844-8060      
St. Luke's-Roosevelt Hospital Center - Roosevelt Division Recruiting
New York, New York, United States, 10019
Contact: Tahir Mirzoyev    212-523-7289      
Sponsors and Collaborators
Beth Israel Medical Center
Principal Investigator: Peter Kozuch, MD Beth Israel Medical Center

Responsible Party: Peter Kozuch, Beth Israel Medical Center - Philipps Ambulatory Care Center
ClinicalTrials.gov Identifier: NCT00831181     History of Changes
Other Study ID Numbers: CDR0000633360
First Posted: January 28, 2009    Key Record Dates
Last Update Posted: June 17, 2009
Last Verified: June 2009

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents