Preoperative CRT With Capecitabine ± Temozolomide in Patients With LARC (NCT03156036) | Clinical Trial Compass
CompletedPhase 2
Preoperative CRT With Capecitabine ± Temozolomide in Patients With LARC
South Korea64 participantsStarted 2017-11-30
Plain-language summary
This is a prospective biomarker-stratified, randomised phase II study of preoperative CRT with temozolomide plus capecitabine in patients with locally advanced rectal cancer.
The primary endpoint is pathologic complete response rates defined as total regression of the primary tumor.
For each cohort of MGMT hypermethylated versus MGMT unmethylated, patients will be randomised (ratio 1:1 for each arm) into preoperative CRT with capecitabine or preoperative CRT with temozolomide plus capecitabine arms. According to the prior phase I results, MGMT hypermethylated arm is estimated as 70% of total patients and the target pathologic complete response rate was assumed as 35% in this population when treated with preoperative CRT with temozolomide and capecitabine (15% in the standard treatment arm or those with unmethylated MGMT). Investigator would like to demonstrate the superiority in terms of pathologic complete responses when treated with preoperative CRT with temozolomide plus capecitabine in patients with locally advanced rectal cancer, and to validate the predictive role of MGMT status
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed adenocarcinoma of the rectum
✓. Tumor located within 12cm of anal verge
✓. Clinical stage of cT3-4Nany (cStage II) or cTanyN1-2 (cStage III) by rectal MRI
✓. Available tumor samples for methylation-specific PCR (MSP) to investigate MGMT hypermethylation
✓. Male or female aged over 20 years
✓. Be ambulatory and have an Eastern Cooperative Oncology Group (ECOG) performance status0-1.
✓. No prior systemic treatment (chemotherapy, immunotherapy) or radiation therapy
✓. Adequate major organ functions as following:
Exclusion criteria
✕. Histology other than adenocarcinoma or tumor arising from inflammatory bowel disease
✕. Inadequate tumor sample for MGMT MSP
What they're measuring
1
Pathologic complete response rate(Pathologic staging and tumor regression grade.)
✕. Unresected synchronous colon cancer; endoscopically resected synchronous colon cancer of pTis or pT1 is permitted
✕. Subjects unable to swallow oral medication because of such as current or impending intestinal obstructions, but bypass surgery (colostomy or ileostomy) is permitted before study treatment
✕. Uncontrolled or severe cardiovascular disease:
✕. Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
✕. Other malignancy within the past 5 years except cured non-melanomatous skin cancer, carcinoma in situ of the cervix, or thyroid papillary carcinoma.