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The current standard treatment of locally advanced rectal cancer (clinical stage II or III) is preoperative radiation with chemotherapy (CRT) followed by surgery. But this approach can be suboptimal for patients with high risk features (more deeply-seated tumor or many regional lymph nodes involved)that are associated with recurrence. This study test a hypothesis that CRT followed by chemotherapy before surgery can improve efficacy of preoperative treatment.
Full description
Downstaging rate with CRT using fluoropyrimidine monotherapy is usually 30-40%.In MRI-defined high-risk patients, downstaging rate with conventional fluoropyrimidine-based monotherapy with radiation has not been shown. We assume that the downstaging rate of chemoradiation arm (control arm) would be 30%, and that addition of CapOx after CRT (experimental arm) may increase downstaging rate 30% to 50%. A sample size of 52 patients per group is needed have 85% power to detect downstaging rate = 50% as compared to 30% with type I error rate of 15%. We will perform one interim futility analysis when half of the patients are recruited and evaluated for the primary endpoint. O'Brien-Fleming boundary will be considered. Therefore, when 26 patients per arm are evaluated, the interim futility analysis will be performed, and when the Z score at the interim is less than -0.09192 (one-sided p-value greater than 0.5366192), the study will be stopped for futility. Considering 5% follow-up loss, a sample size of 55 per arm (a total of 110 patients) will be studied.
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Inclusion criteria
histologically confirmed adenocarcinoma of the rectum
distal margin of tumor located from 0 to 12 cm from anal verge measured by digital rectal examination
high risk clinical stage II or III in MRI (satisfying at least one of the followings)
age 20 years or more
ECOG (Eastern Cooperative Oncology Group) performance status 0-2
No prior chemotherapy, radiotherapy to pelvis
Adequate bone marrow function
Adequate renal function
Adequate hepatic function
patients must sign the informed consent indicating that they were aware of the investigational nature of the study in keeping with the policy of the hospital
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110 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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