Efficacy and Safety of Conventional Neoadjuvant Therapy Versus Total Neoadjuvant Therapy in Older Patients With Locally Advanced Rectal Cancer
Trial Parameters
Brief Summary
The SHAPERS study is a multicentre, open-label, randomised, pragmatic clinical trial, comparing standard-of-care neoadjuvant treatment options for older (i.e., ≥70 years) subjects with high-risk stage II and stage III rectal cancer.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 70 years old 2. ECOG performance status (PS): * ≤1 if age \> 75 years old * ≤2 if age ≤ 75 years old 3. Histologically or cytologically confirmed adenocarcinoma of the rectum 4. Distal border of the tumour below the peritoneal reflection and within 15 cm of the anal verge 5. Operable stage III or high-risk stage II rectal cancer (high-risk tumours defined as those having ≥1 of the following features: T4, mesorectal fascia (MRF) involvement/threatening \[i.e.,tumour within 1 mm of the MRF\], extramural venous invasion). Patient with involvement of lateral pelvic lymph nodes are also eligible. 6. Adequate bone marrow function as defined below: * Absolute neutrophil count ≥1,500/µL * Haemoglobin ≥9 g/dL * Platelets ≥100,000/µL 7. Adequate liver function as defined below: * Serum total bilirubin ≤1.5 x ULN. In case of known Gilbert's syndrome \<3xUNL is allowed * AST (SGOT) and ALT (SGPT) ≤2.5 x ULN * Alkaline phosphatase ≤2.5 x ULN 8. Adequate renal function a