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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of chemotherapy (including Capecitabine and the FOLFOX regimen) and radiation therapy for colorectal cancer that hasn't spread. The goal is to determine if some patients can avoid surgery and preserve their rectum if they respond well to this treatment. It targets those with rectal cancer who are fit for surgery and have not received previous treatments like chemotherapy or pelvic radiation. Participants must be able to take oral medication and adhere to the treatment plan. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in rectal cancer treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking warfarin, phenytoin, or sorivudine.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that hypofractionated intensity-modulated radiotherapy (IMRT) is generally safe and well-tolerated. For example, one study found that this treatment was safe when combined with chemotherapy, and patients managed well with it. Another study on similar radiation methods showed they were effective, and patients handled them without major problems.

Capecitabine, a chemotherapy drug used in this trial, has FDA approval for other types of cancer, indicating its safety is well-documented.

These findings suggest that the treatments in this trial have been well-tolerated in previous studies, making them reasonably safe options for participants. However, like any medical treatment, side effects can occur, and individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments for colorectal cancer?

Researchers are excited about this treatment because hypofractionated radiotherapy significantly reduces the number of sessions needed compared to conventional radiation therapy for colorectal cancer. While traditional radiation therapy might require weeks of daily sessions, this approach delivers an effective dose over just five sessions, potentially increasing patient convenience and comfort. Additionally, the simultaneous integrated boost targets tumors and affected lymph nodes more precisely, potentially enhancing treatment effectiveness while minimizing exposure to healthy tissue.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Studies have shown that hypofractionated pelvic radiotherapy, which involves delivering radiation in larger doses over a shorter period, effectively treats pelvic cancers. Research indicates that this method can better control tumors and reduce side effects. Patients have tolerated this treatment well, and it has become a standard option for pelvic cancers. This trial examines hypofractionated pelvic radiotherapy as a treatment for colorectal cancer. Combining this radiation with chemotherapy, such as capecitabine, can shrink tumors before surgery. This combination might even enable some patients to avoid surgery if their cancer responds completely. ^{2 6 7 8 9}

Who Is on the Research Team?

Neil Kopek, M.D.

Principal Investigator

Radiation Oncologist - Radiation Oncology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11467485/

Evidence-based clinical recommendations for ... In this review, we aimed to summarize the representative evidence and current trends in clinical studies on hypofractionated RT for GU and GY cancers ...

2. e-roj.org e-roj.org/include/download.php?filedata=1598%7Croj-2023-01046.pdf

exploring efficacy and safety-Part 3. Genitourinary a Based on several landmark clinical trials, hypofractionated RT has become an established standard therapeutic regimen for pelvic cancers, ...

3. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2817948

Postoperative Hypofractionated Intensity-Modulated ... Postoperative pelvic irradiation combined with concurrent chemotherapy using hypofractionated IMRT with 40 Gy in 16 fractions was safe and well-tolerated in ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05210270

NCT05210270 | HYpofractionated Pelvic Radiotherapy for ... Dose-adapted HF-RT using intensity-modulated radiotherapy (IMRT) with nodal simultaneous integrated boost (nSIB) could improve tumor control and toxicity.

5. redjournal.org redjournal.org/article/S0360-3016(07)02629-6/fulltext

Comparison of Toxicity Profiles Between Hypofractionated ... The tolerability and efficacy of hypofractionated radiotherapy has been demonstrated in the treatment of pelvic malignancies.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4831968/

Hypofractionated intensity-modulated radiotherapy in ... The aim of this work was to assess the efficacy and tolerability of hypofractionated intensity-modulated radiotherapy (IMRT) in patients with localized ...

7. e-roj.org e-roj.org/journal/view.php?number=1598

Part 3. Genitourinary and gynecological cancers In this review, we aimed to summarize the representative evidence and current trends in clinical studies on hypofractionated RT for GU and GY cancers ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825825008534

prospective phase 2 trial (POHIM_RT study) This study evaluates the safety and efficacy of hypofractionated intensity-modulated radiation therapy (IMRT) following radical hysterectomy.

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.TPS5631

RT-PACE: Phase I/II study of adjuvant whole pelvic ... This phase I/II multi-institutional study evaluates the feasibility, safety, and toxicity profile of HF-WPRT in women with non-metastatic cervical or ...