Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Saint Louis, Missouri 63110


Purpose:

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.


Criteria:

Inclusion Criteria: - Biopsy proven adenocarcinoma of the rectum - Lesion evaluated by surgeon and found to be resectable - Stage T3 or T4 disease on radiography or ultrasound - Karnofsky Performance Status at >60 - Laboratory criteria: - Absolute neutrophil count >= 1.5 K - Platelets >= 100 K - Total Bilirubin <= 2.0; - SGOT and Alkaline Phosphatase <= 2 x upper limit of normal - Creatinine < 2.0 - Informed consent signed - Patients with distant metastatic disease will be eligible if they satisfy all other conditions. Exclusion Criteria: - Pregnant women, children < 18 years, or patients unable to give informed consent - Patients with a past history of pelvic radiotherapy. - Patients with prior malignancy in the past 5 years except: skin cancer or in-situ cervical cancer. However, patients with synchronous adenocarcinomas are eligible provided either (a) the synchronous adenocarcinoma was in a removed pedunculated polyp and did not invade the stalk or (b) the synchronous adenocarcinoma was in a removed polyp that lay within the surgical field (extent of resection would not be changed) or (c) the synchronous adenocarcinoma is smaller than the index rectal cancer and lies completely within the radiation field (clinically favorable second lesion and the extend of radiation and surgery would not be changed). - Patients with known allergy to 5-fluorouracil or irinotecan


Study is Available At:


Original ID:

02-0561


NCT ID:

NCT00682786


Secondary ID:


Study Acronym:


Brief Title:

Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma


Official Title:

Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Washington University School of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

135


Enrollment Type:

Actual


Overall Contact Information

Official Name:Benjamin Tan, M.D.
Principal Investigator
Washington University School of Medicine

Study Dates

Start Date:October 2002
Completion Date:August 2010
Completion Type:Actual
Primary Completion Date:December 2008
Primary Completion Type:Actual
Verification Date:September 2017
Last Changed Date:September 7, 2017
First Received Date:April 11, 2008
First Results Date:July 14, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Rate of Tumor Downstaging Compared With Historical Controls.
Time Frame:1 year after enrollment
Safety Issues:False
Description:Tumor downstaging (DS) is defined as a decrease in the T stage of the primary tumor by at least 1. Historical studies demonstrate a DS rate of 45%.
Outcome Type:Secondary Outcome
Measure:Complete Response Rates
Time Frame:1 year after enrollment
Safety Issues:False
Description:Complete tumor response is defined as the absence of any viable tumor in the rectum (ypT0). Pathologic complete response (pCR) is defined as the absence of any viable tumor in the rectum or in the perirectal lymph nodes (ypT0N0). pCR rate of historical
Outcome Type:Secondary Outcome
Measure:Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation.
Time Frame:Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
Safety Issues:False
Description:The questionnaire is encouraged but not required.
Outcome Type:Secondary Outcome
Measure:Determine Patient Fears and Expectations of Pharmacogenetics.
Time Frame:Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
Safety Issues:False
Description:The questionnaire is encouraged but not required.

Study Interventions

Intervention Type:Drug
Name:5FU
Arm Name:Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3
Other Name:Fluorouracil
Intervention Type:Radiation
Name:Radiation
Arm Name:Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3
Intervention Type:Procedure
Name:Surgery of resectable lesions
Arm Name:Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3
Intervention Type:Drug
Name:Irinotecan
Arm Name:Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4
Other Name:Camptosar

Study Arms

Study Arm Type:Experimental
Arm Name:Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)
Description: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.
Study Arm Type:Experimental
Arm Name:Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Washington University School of Medicine

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.