Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT00682786
Phase
PHASE2
Status
Completed

Conditions

  • Rectal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5FU — DRUG
  • Radiation — RADIATION
  • Surgery of resectable lesions — PROCEDURE
  • Irinotecan — DRUG

Study Details

Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.

Key Dates

Start date
Oct 31, 2002
Status verified
Sep 2017
Primary completion
Dec 31, 2008
Completion
Aug 31, 2010

Study Design

Enrollment
135 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)
    Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.
  • Experimental: Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)
    Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Irinotecan 50 mg/m2 IV weekly for 5 doses. Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.

Primary Outcome Measure

Rate of Tumor Downstaging Compared With Historical Controls. [ Time Frame: 1 year after enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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By research site
Washington University School of Medicine· St Louis, MO

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