Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
1 other identifier
interventional
135
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2002
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 11, 2008
CompletedFirst Posted
Study publicly available on registry
May 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
September 8, 2014
CompletedOctober 6, 2017
September 1, 2017
6.2 years
April 11, 2008
July 14, 2014
September 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Tumor Downstaging Compared With Historical Controls.
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%.
1 year after enrollment
Secondary Outcomes (3)
Complete Response Rates
1 year after enrollment
Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation.
Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
Determine Patient Fears and Expectations of Pharmacogenetics.
Prior to start of study treatment and 3-6 weeks post completion of radiation therapy
Study Arms (2)
Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)
EXPERIMENTALRadiation 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.
Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)
EXPERIMENTALRadiation 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Benjamin R. Tan, M.D.
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Tan, M.D.
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2008
First Posted
May 22, 2008
Study Start
October 1, 2002
Primary Completion
December 1, 2008
Study Completion
August 1, 2010
Last Updated
October 6, 2017
Results First Posted
September 8, 2014
Record last verified: 2017-09