Here is the design of a clinical trial:

Official Title: KCSP Trial of CONsolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After NeoadjUvant Concurrent ChemoraDiothErapy: a Multicenter, Randomized Controlled Trial (KONCLUDE)

Included conditions:
- Rectal Cancer

Study Armgroups:
- {'label': 'Adjuvant chemotherapy', 'type': 'ACTIVE_COMPARATOR', 'description': 'After neoadjuvant chemoradiotherapy, patients will receive surgery followed by eight cycles of chemotherapy.', 'interventionNames': ['Drug: Chemotherapy']}
- {'label': 'Consolidation chemotherapy', 'type': 'EXPERIMENTAL', 'description': 'After neoadjuvant chemoradiotherapy, patients will receive three cycles of chemotherapy. Thereafter, they will receive surgery followed by five cycles of chemotherapy.', 'interventionNames': ['Drug: Chemotherapy']}

Interventions:
- {'type': 'DRUG', 'name': 'Chemotherapy', 'description': '5-FU, Leucovorin, and Oxaliplatin (FOLFOX regimen)', 'armGroupLabels': ['Adjuvant chemotherapy', 'Consolidation chemotherapy']}

Primary Outcomes:
- {'measure': 'Pathologic complete response', 'description': 'Pathologic complete response is defined as no residual tumor on the surgical specimen after chemoradiotherapy. (i.e. Mandard grade 1 or Dworak grade 4)', 'timeFrame': '2 years'}
- {'measure': 'Disease-free survival', 'description': 'The rates of patients who survive without recurrence', 'timeFrame': '3 years'}

Please estimate the sample size based on the assumption: 
The study uses a one-sided proportion test and log-rank test with an α-error of 0.025 and a power of 90% for both primary endpoints: pCR and 3-year DFS. The accrual period is 2 years and the follow-up period is 3 years. A drop-out rate of 10% is considered.
Sample size calculation and randomization
        Based on literatures, pCR rates and 3-year DFS after CRT for rectal cancer were known to be 10 to 28% and 50-65%, respectively [2, 6, 8â13]. Thus we hypothesize that the experimental arm would show a 15% improvement in pCR and in 3-year DFS, compared with the control arm (15 to 30% and 65 to 80%, respectively). The accrual period is 2Â years and the follow-up period is 3Â years. Based on the superiority design, one-sided proportion test and log-rank test with Î±-error of 0.025 and a power of 90% was conducted for both primary endpoints: pCR and 3-year DFS. The pCR of each group was considered to be 15 and 30%, and the 3-year DFS of each group was considered to be 65 and 80% assuming that accrual time was 2Â years and follow up time was 3Â years. Allowing neoadjuvant CRT for a drop-out rate of 10%, 358 patients (179 per arm) for pCR and 316 patients (158 per arm) for 3-year DFS will need to be recruited. Therefore a total of 358 participants (among 358 and 316) are needed. This study of 358 participants had at least 81% power (90% eachâ=â0.9, so 0.9âÃâ0.9â=â0.81) to simultaneously detect a difference of pCR and 3-year DFS of two groups. Randomization will be performed in a 1:1 ratio by computer-generated random numbers, with the use of stratified permuted 4 blocks. It will stratified according to age (<â70 vs. â¥70), clinical T stage (T1/2 or T3), and clinical N stage (N0 or N1/2). Among 8 strata, 2 strata will not be used because clinical T1/2Â N0 (ageâ<â70 andââ¥â70) are not indicated for neoadjuvant CRT.