Recruiting

Internal radiation boost to help rectal cancer patients avoid surgery

Plain-English translation of NCT07292298 on ClinicalTrials.gov ↗ · Source last updated April 2026 · Translation generated July 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing whether rectal brachytherapy — a form of internal radiation therapy delivered directly inside the rectum — can help rectal cancer patients achieve complete tumor response without needing surgery. The treatment uses a special cylinder placed in the rectum that delivers focused radiation to the remaining tumor over three weekly sessions. Researchers hope this approach will help patients keep their rectum and avoid surgical removal.

Many rectal cancer patients who receive standard chemotherapy and external radiation still have some tumor remaining, which typically requires surgical removal of the rectum. This trial exists to see whether brachytherapy can eliminate these remaining tumors completely, allowing patients to preserve their rectum and avoid major surgery.

Do you qualify?

You likely qualify if…

you have been diagnosed with rectal adenocarcinoma (a type of rectal cancer) that has not completely gone away after chemotherapy and radiation
your remaining tumor is small (less than 4 centimeters long and less than 1.2 centimeters thick) and involves less than half the rectal wall
you completed standard chemotherapy and radiation therapy (either conventional or short-course) according to national guidelines
your remaining tumor is located above the dentate line (in the upper part of the rectum) and does not involve the anal canal
you are between 18 and 100 years old and in general good health
if you had lymph node involvement, imaging after chemotherapy and radiation shows those lymph nodes have nearly or completely responded

You likely don't qualify if…

you have a history of ulcerative colitis or Crohn's disease
you have received prior pelvic radiation therapy before your rectal cancer treatment
you have had prior colorectal surgery where an anastomosis (surgical connection) is at or near the treatment area
you have uncontrolled severe medical conditions such as active infections, heart failure, uncontrolled high blood pressure, or serious gastrointestinal conditions causing diarrhea
you are a woman of child-bearing age who is pregnant or unwilling to use contraception during and for 6 months after the treatment

What participation looks like

If you enroll, you will undergo brachytherapy treatment in three separate weekly sessions. Before each session, you will have imaging (MRI and CT scans) and a small clip placed during an endoscopy to mark your tumor. During each treatment session, a soft cylinder is gently placed in your rectum using local numbing medication and sedation; a balloon is inflated to protect healthy tissue, and internal radiation is delivered for less than 10 minutes. You will remain still for up to 3 hours while the cylinder is in place. After completing the three treatments, you will have follow-up appointments similar to other rectal cancer patients to monitor for any recurrence.

AI-generated summary from trial data · Jul 9, 2026 · Not medical advice

Internal radiation boost to help rectal cancer patients avoid surgery

What is this trial?

Do you qualify?

What participation looks like

Trial locations