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Status:

COMPLETED

Neo-adjuvant Chemoradiation With Oxaliplatin/5-FU in Rectal Cancer

Lead Sponsor:

Beth Israel Medical Center

Conditions:

Colorectal Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

RATIONALE: 5FU based neoadjuvant chemoradiation (nCRT) is the standard of care for Stage II/III rectal cancer. Pathologic complete response (pCR) and downstaging have been associated with improved out...

Detailed Description

OBJECTIVES: Primary * To assess the complete pathologic response rate in patients with rectal cancer treated with radiation, modified neoadjuvant FOLFOX 6 chemotherapy followed by total mesorectal e...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Histologically proven adenocarcinoma of the rectum with no distant metastases.
  • T3-4N0M0, TanyN1-3M0 assessed by clinical exam, TRUS, MRI and CT
  • The distal border of the tumor must be at or below the peritoneal reflection, defined as within 12 centimeters of the anal verge by protoscopic examination.
  • No prior chemotherapy or pelvic irradiation.
  • ECOG performance status 0-1
  • Age 18 to 70 years
  • ANC \>= 1500/mm3 and platelets \>= 100,000/mm3
  • Serum creatinine \<= 1.5 x ULN; bilirubin \<= 1.5 x ULN; ALT\<= 2.5 x ULN
  • Exclusion Criteria
  • Pregnant or lactating females; patients not practicing active contraception while sexually active.
  • No other serious medical condition
  • A psychiatric disorder that would prohibit the subject from participating fully.
  • Peripheral neuropathy \> grade 1
  • History within the past 5 years of a cancer diagnosis except for non-melanomatous skin cancers or in situ cervix carcinoma.
  • HIV positive patients

Exclusion

    Key Trial Info

    Start Date :

    July 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2009

    Estimated Enrollment :

    27 Patients enrolled

    Trial Details

    Trial ID

    NCT00831181

    Start Date

    July 1 2004

    End Date

    November 1 2009

    Last Update

    March 20 2018

    Active Locations (2)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Beth Israel Medical Center - Philipps Ambulatory Care Center

    New York, New York, United States, 10003

    2

    St. Luke's-Roosevelt Hospital Center - Roosevelt Division

    New York, New York, United States, 10019