Radiation Therapy + Chemotherapy for Colorectal Cancer

(Hypo-OPRA Trial)

Overseen By Tarel Hijal, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Neil Kopek

Must not be taking: Warfarin, Phenytoin, Sorivudine

Disqualifiers: Previous chemotherapy, Previous radiotherapy, Uncontrolled cardiorespiratory, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

35 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Neil Kopek, M.D.

Principal Investigator

Radiation Oncologist - Radiation Oncology

Eligibility Criteria

This trial is for individuals with locally advanced rectal adenocarcinoma who may benefit from non-surgical treatment options. Participants should be candidates for preoperative pelvic radiation therapy and have not undergone previous treatments that would exclude them from the study.

Inclusion Criteria

I am 18 years old or older.

Specific blood count requirements: Absolute neutrophil count >1.5x10^9/L; platelets >100x10^9/L

Serum transaminase <3 x ULN

Exclusion Criteria

My cancer has spread to other parts of my body.

I do not have severe bowel issues or incontinence.

I haven't had any cancer except skin or cervical cancer in situ treated successfully in the last 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive hypofractionated pelvic radiotherapy with a dose of 25 Gy in 5 fractions, with a simultaneous integrated boost up to 35 Gy on sites of gross disease

1 week

Chemotherapy

Participants may receive sequential chemotherapy with FOLFOX/CAPOX following radiotherapy

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the rate of failure to achieve complete response or recurrence

1 year

Treatment Details

Interventions

• Capecitabine
• FOLFOX regimen
• Radiation Therapy

Trial Overview The Hypo-OPRA trial is testing whether a combination of hypofractionated pelvic radiation therapy (shorter, more intense doses) with or without chemotherapy can help preserve the rectum in patients showing complete clinical response, potentially avoiding surgery.

Participant Groups

Group I: Hypofractionated Pelvic Radiotherapy Experimental Treatment 3 Interventions

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).

Who Is Running the Clinical Trial?

Neil Kopek

Lead Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborator

Trials

476

Recruited

170,000+