Brachytherapy for Rectal Cancer to Avoid Surgery

Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

Recruiting Phase 2 Interventional Study
Rectal Adenocarcinoma Rectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
44 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for

This trial is looking for patients with rectal cancer who did not achieve a complete response to previous treatments. Participants will receive internal radiation therapy to see if it helps avoid the need for surgery.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am an adult between 18 and 100 years old.
  • I can sign and date the consent form.
  • I am willing to follow all study procedures.
  • I have low-mid rectal adenocarcinoma that has not completely responded to previous treatment.
  • My remaining rectal disease measures less than 4 cm in length and not affecting the anal canal.
  • I have recovered from previous treatments and have no major rectal incontinence.
  • I have had certain types of chemotherapy and radiation as required before the study.

You may not be able to join if

  • I have a history of ulcerative colitis or Crohn's disease.
  • I received pelvic radiotherapy before this treatment.
  • I have had recent colorectal surgery near the area being treated.
  • I have any severe illness that would limit my ability to participate.
  • My life expectancy is less than 3 years.
  • I am currently taking any chemotherapy or immunotherapy.
  • I have been treated for rectal cancer outside of standard guidelines.
  • I am pregnant.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial
Rectal cancer patients who do not achieve a complete response to standard of care chemotherapy and radiation often require surgical resection as part of curative intent therapy. This study will evaluate whether additional "focal" radiation delivered internally (rectal brachytherapy) can provide complete responses and thus spare the requirement for surgery. The main questions are whether: 1) recta…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Adults (18-100 years old) 4. ECOG 0-3 5. Patients with MMR-proficient low-mid rectal adenocarcinoma cT1-4 N0-2 M0 who unde…
Contacts

Radiation Therapy Group

303-724-8822

RTClinicalResearch@olucdenver.onmicrosoft.com

CONTACT