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) rectal brachytherapy is safe in this clinical treatment paradigm and if 2) rectal brachytherapy improves organ preservation (no need for surgery).
The trial involves an additional MRI pelvis and sigmoidoscopy with marker placement to define high-risk residual disease for radiation planning. Subsequently, 3 outpatient brachytherapy treatments are given on a weekly basis. If a patient achieves a complete response to brachytherapy, standard of care non-operative surveillance visits are conducted with study visits aligned during the first two years following brachytherapy.
Provision to sign and date the consent form.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Adults (18-100 years old)
ECOG 0-3
History of ulcerative colitis or Crohn's disease.
Pelvic radiotherapy given prior to rectal cancer external beam radiation.
Prior colorectal surgery in which anastomotic site is at or near HDR brachytherapy target.
Uncontrolled intercurrent severe illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
Single group
High Rare Dose Rectal Brachytherapy Boost
RadiationHDR rectal brachytherapy boost using Iridium-192 delivered via an intracavitary applicator in three weekly fractions (total dose: 21 Gy) for patients with low-lying residual rectal adenocarcinoma following total neoadjuvant therapy.
Organ preservation (no surgical requirement) of the rectum associated with complete clinical response
As evaluated by standard of care sigmoidoscopy and MRI
Locoregional recurrence free survival
As defined by CT and MRI pelvis
Distant metastatic free survivial
As assessed by CT c/a/p
Overall survival
Overall survival
Bowel function
As assessed by LARS (low anterior resection syndrome) questionnaire
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University of Colorado, Denver
Lead sponsor
Cancer League of Colorado
Collaborator
