RecruitingPhase 2NCT06991465

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

Organ Preservation in Rectal Adenocarcinoma Using Hypofractionated Pelvic Radiotherapy (Hypo-OPRA): A Phase II Clinical Trial

Sponsor

Neil Kopek

Enrollment

35 participants

Start Date

Aug 16, 2023

Study Type

INTERVENTIONAL

Conditions

Colorectal Carcinoma

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria13

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 Criteria13

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