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New treatment option for Rectal Adenocarcinoma
Official title Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
ClinicalTrials.gov ID: NCT07292298
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 3 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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
- Patients with MMR-proficient low-mid rectal adenocarcinoma cT1-4 N0-2 M0 who underwent total neoadjuvant therapy who have not achieved complete...
You likely can't join if
- 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. o Prior local excision is not an exclusion criterion.
- Uncontrolled intercurrent severe illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure...
- Life expectancy \<3 years per provider discretion.
- Concurrent administration of any cytotoxic chemotherapy, immunotherapy, or other any targeted oncologic agent that would impact rectal cancer is not...
See the full eligibility criteria
- 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
- 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...
- 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...
- 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...
- Interval of time between completion of TNT and initiation of rectal brachytherapy must be between 4-16 weeks.
- Patients must be recovered from total neoadjuvant therapy and must not have significant rectal incontinence at time of screening.
- 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...
- Women of child-bearing potential must have a negative urine or serum pregnancy test within 14 days of HDR treatment.
- 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.
- 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
- 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. o Prior local excision is not an exclusion criterion.
- Uncontrolled intercurrent severe illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia...
- Life expectancy \<3 years per provider discretion.
- Concurrent administration of any cytotoxic chemotherapy, immunotherapy, or other any targeted oncologic agent that would impact rectal cancer is not allowed during study protocol.
- 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...
- Pregnant women.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Rochester, New York, United States
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Rochester, New York, United States; Portland, Oregon, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.