Brachytherapy for Rectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding internal radiation (rectal brachytherapy) to the treatment routine can help rectal cancer patients avoid surgery. It targets those who did not fully respond to initial chemo and radiation treatments. Participants must have rectal cancer that has not spread extensively and must have already received specific cancer treatments. The trial will assess whether this approach is safe and effective in preserving the organ without surgery. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from innovative therapy.
Will I have to stop taking my current medications?
The trial does not allow the use of any cytotoxic chemotherapy, immunotherapy, or other targeted cancer treatments during the study. If you are on these types of medications, you would need to stop them to participate.
What prior data suggests that rectal brachytherapy is safe for rectal cancer patients?
Previous studies have shown that rectal brachytherapy is generally safe for patients. Research indicates that most people tolerate this treatment well. For example, one study reported excellent results with endorectal high-dose-rate brachytherapy for rectal cancer, suggesting that side effects may not be severe for most patients.
Other research has found that this method can safely improve cancer outcomes. While specific side effects were not detailed, the overall findings support its safety in patients.
Although this trial is still collecting data, the treatment's use in other settings provides some confidence in its safety. Discuss any concerns with the study team, as they can provide more details on what to expect.12345Why do researchers think this study treatment might be promising for rectal cancer?
Unlike standard treatments for rectal cancer, which often involve surgery or external radiation, HDR Rectal Brachytherapy Boost offers a targeted internal radiation approach. This treatment uses Iridium-192 delivered through an intracavitary applicator, allowing for precise radiation to the tumor while sparing surrounding healthy tissue. Researchers are excited because this method could improve organ preservation and potentially help patients avoid invasive surgeries, like abdominal perineal resection (APR) or low anterior resection (LAR).
What evidence suggests that rectal brachytherapy is effective for rectal cancer?
Research has shown that rectal brachytherapy, administered in this trial as an HDR Rectal Brachytherapy Boost, can effectively treat rectal cancer. One study found that 63.8% of patients experienced complete cancer remission after this treatment. Another study revealed that patients who received brachytherapy were significantly more likely to avoid surgery, with up to 79% not requiring it. While there is a risk of cancer returning elsewhere in the body, the ability to control the tumor locally and preserve the organ is promising. This suggests that rectal brachytherapy could be a viable option for patients seeking to avoid surgery after standard treatments.16789
Who Is on the Research Team?
David Binder
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
This trial is for rectal cancer patients who still have low-lying residual adenocarcinoma after receiving the standard chemotherapy and radiation but haven't had surgery yet. It's designed to see if additional internal radiation can help avoid the need for surgical removal of affected organs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rectal brachytherapy with 3 weekly outpatient treatments totaling 21 Gy
Follow-up
Participants are monitored for safety and effectiveness after treatment, with surveillance visits aligned during the first two years following brachytherapy
What Are the Treatments Tested in This Trial?
Interventions
- Rectal Brachytherapy
Trial Overview
The study tests high dose rate rectal brachytherapy, a type of internal radiation therapy, as an extra treatment step. The goal is to find out if this focal radiation can eliminate remaining cancer cells and preserve organs without surgery.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
The intervention consists of a boost using Iridium-192 delivered via an intracavitary applicator in three weekly fractions totaling 21 Gy. The goal is to improve organ preservation rates and avoid surgical resection (APR or low LAR). Treatment planning includes MRI, endoscopic clip placement, and CT simulation prior to each fraction.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Cancer League of Colorado
Collaborator
Citations
High‐dose rate endorectal brachytherapy for rectal cancer
Most patients received a total of 90 Gy of CXB in three fractions within 4 weeks. Of these 83 patients, 53 (63.8%) achieved cCR. This suggests ...
5 year results of the OPERA trial
5-year organ preservation rate was significant in favour of the contact X-ray brachytherapy arm: 56% versus 79% (P = 0.004).
Contact X-ray Brachytherapy as a Boost Therapy After ...
High-risk patients with rectal cancer treated with CXB boost had more distant relapses, but comparable locoregional tumor control, organ ...
Long-Term Results of a Randomized Trial in Locally ...
Mature data on tumor control and survival are presented from a randomized trial of the addition of a brachytherapy boost to long-course neoadjuvant ...
A Phase-II Clinical Trial - PMC - PubMed Central - NIH
The present study aims to investigate the efficacy and the safety of low-dose-rate endorectal brachytherapy (LDRBT) as a boost to neoadjuvant chemoradiation for ...
Endorectal high-dose-rate brachytherapy boost in rectal ...
Excellent outcomes were described after using endorectal high-dose-rate (HDR) brachytherapy boost in the non-operative management of rectal cancer.
ACO/ARO/AIO-22 – External beam radiotherapy combined ...
Even with CXB alone, patients with stage I rectal cancer can achieve favourable outcomes, including a cCR rate of 82 % and 3-year local control of 84 %, with ...
AB053. SOH24AB_227. Safety and efficacy of neo-adjuvant ...
Conclusions: High-dose rate endorectal brachytherapy may represent a safe and effective method of improving oncological outcomes in patients with locally ...
Phase 2 Single-Arm Rectal Cancer Brachytherapy for ...
While rectal brachytherapy efficacy, technique, and safety has been demonstrated in previous studies conducted in Europe and Canada, it has not ...
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