Organ Preservation in Rectal AdenoCa Using Hypofractionated Pelvic RT(Hypo-OPRA)

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

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 randomisation)
* T1 or T2 N0 disease without extra-mural venous invasion
* Unequivocal evidence of metastatic disease (includes resectable metastases)
* Major impairment of bowel function without defunctioning stoma/ileostomy (baseline grade 3 diarrhoea or clinically significant faecal incontinence
* Known dihydropyrimidine dehydrogenase deficiency
* History of another malignancy within the last 5 years except successfully treated basal cell cancer of skin or carcinoma in situ of uterine cervix.
* Known Gilberts disease (hyperbilirubinaemia)
* Taking warfarin or phenytoin or sorivudine
* Gastrointestinal disorder which would interfere with oral therapy and its bioavailability
* Pregnant, lactating, or pre-menopausal women not using adequate contraception
* Unfit to receive any study treatment or subsequent surgical resection

Conditions2

Interventions2

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