A Phase 2 interventional study of Capecitabine Oxaliplatin and pelvic radiation capecitabine 5-fluorouracil in Rectal Neoplasms and Adenocarcinoma, sponsored by National Cancer Center, Korea. Status unknown at 7 sites in South Korea. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-09-13.
Sponsored by National Cancer Center, Korea · Phase 2, Interventional, and Treatment
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.
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.
1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.
This study's enrollment of 110 is above the median of 66 across 1,330 interventional studies indexed under Rectal Neoplasms.
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high risk clinical stage II or III in MRI (satisfying at least one of the followings)
Exclusion Criteria:
preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by 2 cycles of chemotherapy (Capecitabine Oxaliplatin - CapOx) and surgery (total mesorectal excision)
Drug: Capecitabine Oxaliplatin · Radiation: pelvic radiation capecitabine 5-fluorouracil
preoperative chemoradiation 50.4Gy with capecitabine or 5-fluorouracil/leucovorin (pelvic radiation capecitabine 5-fluorouracil) followed by rest for 8 weeks and surgery (total mesorectal excision)
Radiation: pelvic radiation capecitabine 5-fluorouracil
after completion of chemoradiation, two cycles of capecitabine (850mg/m2 twice daily from D1 evening to D15 morning) and oxaliplatin (100mg/m2 on D1) will be administered every 3 weeks.
Also known as: Xeloda, Oxalitin
50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil
Also known as: preoperative chemoradiation, xeloda
downstaging rate
downstaging rate is defined as the proportion of patients with ypStage (pathologic stage after preoperative treatment) 0 or I (from pathologic findings after preoperative treatment and surgery) out of all patients who were assigned to each arm.
Time frame: expected average of 15 weeks after start of study treatment
pathologic response
pathologic response is assessed by Dworak's grading system from postoperative specimen.
Time frame: expected average of 15 weeks after start of study treatment
radiologic response rate
radiologic response will be assessed according to RECIST (Response Evaluation Criteria in Solid Tumors) guideline 1.1
Time frame: expected average of 14 weeks after start of study treatment
toxicity profile
Toxicities or any adverse events during study treatment, surgery and follow-up period will be assessed according to NCI CTCAE (Common Terminology Criteria for Adverse Events) version 4.0
Time frame: expected average of 35 weeks after start of study treatment
pattern of failure
if any recurrent lesion is noticed, anatomic sites of recurrent lesions and the date and the name of exam or imaging study (physical exam, CT or MRI…) will be recorded in case report form.
Time frame: 3 years after surgery
local control rate
Local recurrence is defined as tumor recurrence confined in radiation field (pelvic cavity). Cumulative incidence of local recurrence will be suggested.
Time frame: 3 years after surgery
relapse-free survival
Time from date of operation to date of recurrence of disease or deaths due to recurrence or progression of disease.
Time frame: 3 years after surgery
Disease-free survival
time from date of operation to date of recurrence of disease, a new occurrence of secondary colorectal cancer, a new occurrence of other malignancy, or deaths from any cause.
Time frame: 3 years after surgery
overall survival
time from date of operation to date of death due to any cause.
Time frame: 3 years after surgery
quality of life
quality of life will be measured with FACT-C
Time frame: before study treatment, 7 weeks after completion of chemoradiation, and at 4 weeks after surgery
Plan to share: Undecided
The record gives a start of Jun 2014, a primary completion of Sep 2017 and a completion of Dec 2019. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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