Phase 2 Study on Internal Radiation Therapy for Rectal Cancer to Avoid Surgery
Sponsor: University of Colorado, Denver
ClinicalTrials ID:NCT07292298
This study is testing if an additional internal radiation treatment, called rectal brachytherapy, can help patients with rectal cancer avoid surgery by achieving a complete response after standard chemotherapy and radiation.
Patient Parameters
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Program Overview
Patients with rectal cancer who don't fully respond to standard chemotherapy and radiation often need surgery. This study is exploring whether an extra internal radiation treatment, known as rectal brachytherapy, can help achieve complete tumor responses, potentially allowing patients to avoid surgery. The study will assess if this treatment is safe and if it improves the chances of preserving the rectum without surgery. Participants will undergo additional MRI and sigmoidoscopy to plan the radiation, followed by three weekly outpatient brachytherapy sessions. If a complete response is achieved, patients will have regular follow-up visits similar to those who respond completely to standard treatments.
Description
This study focuses on patients with rectal cancer who haven't fully responded to standard chemotherapy and radiation. Typically, these patients might need surgery to remove the cancer. The goal of this study is to see if an additional internal radiation treatment, called rectal brachytherapy, can help achieve a complete response, allowing patients to avoid surgery.
Rectal brachytherapy involves placing a special device inside the rectum to deliver focused radiation directly to the tumor. This treatment has been effective in other countries but hasn't been tested in the U.S. for boosting responses after standard treatments. During the procedure, a device is inserted into the rectum, and a balloon is inflated to protect healthy tissue. Radiation is then delivered through the device to target the tumor. Each session lasts about three hours, with the actual radiation taking less than 10 minutes.
If the treatment is successful and the tumor responds completely, patients will have regular follow-up visits to monitor their health, similar to those who respond to standard treatments.
Eligibility Criteria
Inclusion Criteria
- Must be able to sign and date the consent form.
- Willing to follow all study procedures and be available for the study duration.
- Adults aged 18 to 100 years.
- Have a performance status score of 0 to 3, indicating varying levels of activity.
- Diagnosed with specific types of rectal cancer that haven't fully responded to initial treatments and would require surgery if not treated further.
- Tumor must be less than 4 cm in length and less than 1.2 cm thick, with less than 50% of the rectum involved.
- Must have shown at least a near-complete response in pelvic lymph nodes after initial therapy.
- Must start brachytherapy between 4 to 16 weeks after completing initial therapy.
- Must have recovered from initial therapy and not have significant rectal incontinence.
- Must have received specific doses of radiation and chemotherapy as per guidelines.
- Women of childbearing potential must have a negative pregnancy test before treatment.
- Men and women of reproductive potential must agree to use contraception during and for 6 months after the study.
- Must have certain blood counts above specified levels at screening.
Exclusion Criteria
- History of ulcerative colitis or Crohn's disease.
- Previous pelvic radiation before rectal cancer treatment.
- Previous colorectal surgery near the treatment area, except for local excision.
- Severe uncontrolled illnesses or conditions that could interfere with the study.
- Life expectancy of less than 3 years.
- Cannot receive other cancer treatments during the study.
- Must have followed standard treatment guidelines before joining the study.
- Pregnant women are not eligible.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Colorado Cancer Center | 80045 | Aurora | Colorado |
| University of Rochester Medical Center | 14642 | Rochester | New York |
| Oregon Health and Sciences University | 97239 | Portland | Oregon |
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