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

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with locally advanced rectal cancer can avoid surgery altogether — by using an intensified radiotherapy approach (called hypofractionated radiotherapy) combined with chemotherapy in hopes of eliminating the tumor entirely. **You may be eligible if...** - You are 18 or older - You have confirmed rectal cancer (adenocarcinoma) that has grown into surrounding tissue (T3–T4 stage) - You are considered fit enough for potential surgery - You have no confirmed spread to distant organs - You have not previously received chemotherapy or pelvic radiation **You may NOT be eligible if...** - You have had prior chemotherapy or pelvic radiation - Your cancer has already spread to other parts of the body - You have severe heart or breathing problems - You have a known enzyme deficiency (DPD deficiency) that affects how chemotherapy is processed - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.