About this trial
A multicenter single-arm phase 2 study to evaluate safety and efficacy of the total neoadjuvant therapy of short course radiation therapy followed by neoadjuvant oxaliplatin/fluorouracil-based chemotherapy (CAPOX) for cT2 rectal cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. The patient has been fully informed of the contents of the study and has given written consent.
Neutrophil count: greater than or equal to 1,500/mm3
Platelet count: >= 10.0 x 104 /mm3
Hemoglobin concentration: >=9.0 g/dL
Disqualifiers
1. underwent treatment by any of the following within a certain period of time prior to initiation of protocol therapy
extensive surgery (excluding CV port placement) within 4 weeks
Any anticancer therapy within 4 weeks
Radiation within 4 weeks 2. concomitant or pre-existing severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.) 3. patients who have had a colonic stent implanted 4. patients with serious comorbidities (heart failure, renal failure, liver failure, bleeding peptic ulcer, intestinal paralysis, bowel obstruction, poorly controlled diabetes, etc.) 5. patients with active multiple overlapping cancers (synchronous multiple overlapping cancers or iatrogenic multiple overlapping cancers with a disease-free period of 5 years or less). However, carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma that is considered curable by local treatment is not considered active multiple overlapping carcinoma.
Trial design
Sequential
Treatments tested in this trial
Radiation
RadiationNeoadjuvant radiation therapy : 5Gyx5
Chemotherapy
DrugCAPOX (Oxaliplatin 130mg/m2, Capecitabine2000mg/m2/day, d1-14, 3week)x6cycles
Surgery
Procedure/SurgeryOperation: Total methorectum excision wiht radical lymph node dissection
Treatment groups
Trial outcomes
Primary outcomes
Pathological complete response (pCR)
pCR is evaluated by using the grading scale according to the Japanese Classification of Colorectal, Appendiceal, and Anal Carcinoma
Sponsors and contacts
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