To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy.
Our principal objectives in this trial will be to determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU (oral capecitabine if 5FU is unavailable), oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy. If we can establish a T stage downstaging rate that is significantly better than 50% and if acute tolerance is acceptable, then we would consider this study as having provided sufficient pilot data to support including this approach as an arm in a multi-institution phase III trial. The long-term goal is improved overall control of disease by delivering better chemotherapy earlier.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Washington University School of Medicine
St Louis, Missouri, United States
Rate of T Stage Downstaging
T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).
Time frame: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
Preoperative Gastrointestinal Morbidity
As measured by participants who experience grade 3 or higher gastrointestinal morbidity
Time frame: Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
Incidence of Any Late Grade 3 or Higher Morbidity
Time frame: Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks)
Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity
Time frame: 1 year (completion of all treatment)
Local Control
* Kaplan-Meier projections * Local control = control of primary tumor
Time frame: 30 months
Rate of Overall Control
Time frame: 1 year
Rate of Locoregional Control
Time frame: 1 year
Freedom From Disease Relapse
Kaplan-Meier projections.
Time frame: 30 months
Determine Quality of Anorectal Function
Anorectal function was measured by the participant's response to the FACT-C questionnaire question "I have control of my bowels". The answers ranged from 0=not at all to 4=very much.
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Time frame: Up to 1 year