The purpose of this research study is to look at how tumors responds to a short course of radiation (5 days) followed by 8 cycles of chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Washington University School of Medicine
St Louis, Missouri, United States
Complete Response Rate
* Criteria for complete clinical response: * No residual gross tumor at procto/sigmoidoscopy, or only erythematous scar or ulcer * No radiographic evidence of tumor on DRE * Substantial downsizing on MRI * No suspicious mesorectal lymph nodes on MRI * Negative biopsy from scar, ulcer, or former tumor site (if necessary according to surgeon's judgment) * Criteria for no significant clinical response: * Residual disease by DRE, endoscopy or MR. * Increase in primary tumor size upon clinical exam or imaging * Any new lesions
Time frame: 1 year
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).
Time frame: Baseline
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).
Time frame: Completion of chemoradiation (approximately 112 days)
Prospective Patient Reported Outcomes as Measured by FACT-C Questionnaire
-The FACT-C questionnaire is broken down into physical well-being, social/family well-being, emotional well-being, and functional well-being. The answers range from 0 (not at all) to 4 (very much).
Time frame: 10-14 months after chemoradiation (approximately 16-20 months)
Number of Any Grade 3 or Higher Toxicities
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
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Time frame: From start of radiation treatment through 30 days after completion of treatment (approximately 18 weeks)
Number of Post Chemotherapy Grade 3 or Higher Toxicities
-The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Time frame: Post-chemotherapy through 1 year follow-up (approximately 1 year and 4 months)
Quality of Anorectal Function as Measured by the FACT-C Questionnaire
-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)
Time frame: Baseline
Quality of Anorectal Function as Measured by the FACT-C Questionnaire
-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)
Time frame: Completion of chemoradiation (approximately 112 days)
Quality of Anorectal Function as Measured by the FACT-C Questionnaire
-The FACT-C questionnaire has 2 statements about anorectal function and the participant answers 0 (not at all) to 4 (very much)
Time frame: 10-14 months after chemoradiation (approximately 16-20 months)