Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA)
Trial Parameters
Brief Summary
The combination of preoperative pelvic RT - either long-course chemoradiotherapy (LCCRT) or short-course radiotherapy (SCRT)- followed by surgery has been the standard of care in the curative treatment of locally advanced adenocarcinoma of the rectum for decades. Some patients however achieve a complete clinical response (cCR) to their preoperative treatment which opens the possibility of avoiding surgery and consequently preserving the rectum. There now exists a growing body of data from centres around the world validating the safety of a surveillance approach in clinical complete responders treated with LCCRT.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed invasive adenocarcinoma of the rectum * Pelvic MRI defined disease (at least one of the following): mesorectum involved or breached - includes involvement of adjacent organ(s) (T3-T4) * Patients are considered medically fit for oncologic resection * ECOG performance status 0 or 1 * No evidence of established metastatic disease (CT chest and abdomen) * Absolute neutrophil count \>1.5x109/L; platelets \>100x109/L, * Serum transaminase \<3 x ULN; * Adequate renal function (Cockroft Gault estimation \>50 mL/min) * Bilirubin \<1.5 x ULN * Ability to comply with oral medication * Willingness and ability to give informed consent and comply with treatment and follow up schedule * Age 18 or over Exclusion Criteria: * Previous chemotherapy * Previous radiotherapy to the pelvis (including brachytherapy) * Uncontrolled cardiorespiratory comorbidity (includes patients with inadequately controlled angina or myocardial infarction within 6 months of rando