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

NCT06991465 | Recruiting Phase 2 DMC

• 1 other identifier: 2023-9472
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Feasibility of Hypo-fractionated Approach in 5 fractions for a dose of 35Gy

  Rate of failure to achieve CR or the rate of recurrence after achieving CR

  One year

Study Arms (1)

Hypofractionated Pelvic Radiotherapy

EXPERIMENTAL

A single arm consisting of hypofractionated RT dose of 25 Gy in 5 fractions once daily fractions of intensity modulated radiotherapy (IMRT) with a simultaneous integrated boost up to 35 Gy on sites of gross disease (tumour and lymphadenopathy).

Radiation: Radiation Therapy; Drug: FOLFOX regimen; Drug: Capecitabine

Interventions

Radiation Therapy RADIATION

High Dose Hypofractionated Radiotherapy 35 Gy over 5 fractions.

Also known as: Hyofractionated Radiotherapy

Hypofractionated Pelvic Radiotherapy

FOLFOX regimen DRUG

Radiosensitizing chemotherapy

Hypofractionated Pelvic Radiotherapy

Capecitabine DRUG

Radiosensitizing chemotherapy

Hypofractionated Pelvic Radiotherapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neil Kopek: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (28)

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MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Radiotherapy; Folfox protocol; Capecitabine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Neil Kopek, M.D.

  Radiation Oncologist - Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil Kopek, M.D.

CONTACT

514-934-4400; neil.kopek@muhc.mcgill.ca

Tarel Hijal, M.D.

CONTACT

514-934-4400; tarek.hijal@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: To 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.

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 28, 2025
• Study Start: August 16, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)