RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The trial involves an additional MRI pelvis and sigmoidoscopy with marker placement to define high-risk residual disease for radiation planning."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether extra radiation given inside the rectum is safe and can help people avoid surgery. It is for adults with rectal cancer that has not fully gone away after chemotherapy and radiation. Patients receive 3 treatments, one each week, without staying overnight.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18–100 years old, sign a consent form, and agree to study visits and procedures.
  • Have an ECOG activity score of 0–3, which measures how well you can do daily tasks.
  • Have cancer in the lower or middle rectum that has not spread to distant body parts and is MMR-proficient, meaning its DNA repair system works. Cancer must remain after treatment, and experts must agree that major rectal surgery would be needed.
  • The remaining tumor must be less than 4 cm long, less than 1.2 cm thick, and cover less than half the rectum's inner wall. It must sit above the dentate line, a border inside the anus, and not enter the anal canal.
  • If cancer was in nearby lymph nodes, scans must show it is gone or nearly gone from those nodes, as confirmed by expert review.
  • Have finished standard chemotherapy and radiation and recovered, without major trouble controlling bowel movements. Radiation must have been 45–56 Gy with chemotherapy or a short course of 25 Gy; Gy measures radiation dose.
  • Have cancer reassessed 4–16 weeks after treatment, but no sooner than 8 weeks if chemotherapy came before radiation. Start study radiation 4–16 weeks after treatment ends.
  • Meet required blood count levels. If able to become pregnant, have a negative pregnancy test within 14 days before treatment. Sexually active people who can have children must follow birth control instructions during the study and for 6 months afterward.

Who can't join

  • Have a history of ulcerative colitis or Crohn's disease, which cause swelling in the bowel.
  • Had radiation to the pelvis before radiation for this rectal cancer.
  • Had colon or rectal surgery with a bowel join at or near the study treatment area. Prior surgery to remove only a small local area does not rule you out.
  • Have a serious, uncontrolled illness or a mental health or social problem that makes participation unsafe, prevents following study rules, or prevents informed consent.
  • Are expected by your care provider to live less than 3 years.
  • Receive chemotherapy, immunotherapy, or targeted cancer drugs that affect rectal cancer during the study.
  • Had rectal cancer treatment outside standard chemotherapy and radiation guidelines, including radiation doses above the study's limits.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 underwent total neoadjuvant therapy who have not achieved complete response (i.e. incomplete or near-complete) in the rectal primary tumor such that surgical resection, if offered presently or in the future, would be an APR or low LAR per colorectal surgeon expert opinion and central review at University of Colorado rectal tumor board. Tumor restaging will be 4-16 weeks following completion of total neoadjuvant therapy, and no sooner than 8 weeks if patients received chemotherapy followed by chemoradiation/short course radiation. 6. Residual rectal disease must have its craniocaudal extent \<4 cm with thickness \<1.2 cm. Tumor must have \<50% circumferential involvement. Residual disease must be above the dentate line and not involving the anal canal. 7. In patients with original cN1-2 disease, restaging CT and MRI after total neoadjuvant therapy must demonstrate at least near-complete response of the pelvic lymph nodes per NCCN criteria as evaluated by central review at University of Colorado rectal tumor board. 8. Interval of time between completion of TNT and initiation of rectal brachytherapy must be between 4-16 weeks. 9. Patients must be recovered from total neoadjuvant therapy and must not have significant rectal incontinence at time of screening. 10. Received conventionally fractionated external beam chemoradiation between 45-56 Gy or short-course external beam radiation prescription of 25 Gy to rectal mucosa, in addition to systemic chemotherapy before or after radiation per National Comprehensive Cancer Network (NCCN) guidelines. 11. Women of child-bearing potential must have a negative urine or serum pregnancy test within 14 days of HDR treatment. 12. Men and women of reproductive potential who are sexually active must agree to follow instructions of contraception for the duration of the study and 6 months post-rectal brachytherapy completion. 13. CBC at the time of screening must have platelets\>50 10\^9/L, Hemoglobin\>8 g/dL and Absolute Neutrophil Count \> 500 10\^9/L Exclusion Criteria: 1. History of ulcerative colitis or Crohn's disease. 2. Pelvic radiotherapy given prior to rectal cancer external beam radiation. 3. Prior colorectal surgery in which anastomotic site is at or near HDR brachytherapy target. o Prior local excision is not an exclusion criterion. 4. 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. 5. Life expectancy \<3 years per provider discretion. 6. Concurrent administration of any cytotoxic chemotherapy, immunotherapy, or other any targeted oncologic agent that would impact rectal cancer is not allowed during study protocol. 7. If rectal cancer has been treated outside of standard total neoadjuvant therapy per NCCN guidelines, patients are ineligible for the trial. This includes if patients received external beam chemoradiation dose with prescription \>56 Gy or short-course radiation to rectal mucosa prescription \>30 Gy. 8. Pregnant women.

Study sites (3)

CO

NY

OR