Here is the design of a clinical trial:

Official Title: Neo-adjuvant FOLFOXIRI and Chemoradiotherapy for High Risk ("Ugly") Locally Advanced Rectal Cancer

Included conditions:
- Rectal Cancer

Study Armgroups:
- {'label': 'Single-arm study', 'type': 'EXPERIMENTAL', 'description': 'All patients will receive induction chemotherapy consisting of 4-6 cycles of FOLFOXIRI. Restaging will be performed after 4 cycles with a pelvic MRI and a thoraco-abdominal CT-scan. In case of stable or responsive disease, the remaining 2 cycles of FOLFOXIRI will be provided. In case of progressive, but still resectable disease, chemoradiation will be provided immediately, without the remaining 2 cycles of FOLFOXIRI. Restaging will be performed after chemoradiation. In case of resectable disease, surgery is performed.', 'interventionNames': ['Drug: FOLFOXIRI Protocol']}

Interventions:
- {'type': 'DRUG', 'name': 'FOLFOXIRI Protocol', 'description': "FOLFOXIRI consists of oxaliplatin, irinotecan, leucovorin and 5-fluorouracil and is administered every 2 weeks:\n\nDosing:\n\n* Day 1: irinotecan 165 mg/m2 body-surface area (BSA) intravenously (IV), followed by oxaliplatin 85mg/m2 BSA IV in combination with leucovorin 400mg/m2 BSA, followed by:\n* Day 1-2: 3200 mg/m2 BSA of continuous 5-fluorouracil IV\n* Day 3-14: rest days.\n\nBoth regimen are initially administered for four cycles. In case of responsive or stable disease, a 5th and 6th cycle of FOLFOXIRI will be administered.\n\nIn case of unacceptable toxicity, the aforementioned dosages can be reduced or one or more chemotherapeutical agents can be omitted at discretion of the medical oncologist and will be noted in the patient's medical file. At discretion of the medical oncologist, a start dosage of 75% of the advised dosage could be considered in patients above 70 years of age.", 'armGroupLabels': ['Single-arm study']}

Primary Outcomes:
- {'measure': 'The main study parameter is the proportion of patients with a pathological complete response (pCR) and those patients who started a wait and see strategy and have sustained clinical complete response (cCR) at 1 year.', 'description': 'The pCR is evaluated by an experienced pathologist. A pCR is defined as the absence of residual tumour cells in the complete resected specimen including all resected regional lymph nodes (ypT0N0). A cCR is defined as the absence of viable tumour tissue based on MRI, evaluated by an experienced radiologist. There is a cCR in case of a sustained clinical response at 1 year after chemoradiotherapy.', 'timeFrame': 'pCR is determined after surgery directly. There is a cCR in case of a sustained clinical response until at least one year after chemoradiotherapy'}

Please estimate the sample size based on the assumption: 
A 5% significance level, 90% power, and a 5% dropout rate are assumed.
Sample size
        A 10% CR rate is assumed in patients diagnosed with hr-LARC, treated with chemoradiotherapy alone prior to surgery [30, 32]. Based on the available literature and a retrospective analysis of patients from our own institution a CR rate of 20% is hypothesised after neoadjuvant chemotherapy and chemoradiotherapy for hr-LARC [30, 32, 33]. A 5% significance level and a 90% power, resulted in a total of 121 required patients. A drop-out of 5% is expected, resulting in a total sample size of 128 patients.