Clinical trial · Interventional
Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer
Phase II Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research is being done to see how effective high-dose rate endorectal brachytherapy (HDRBT) is in treating cancer of the lowest part of the bowel (rectum). In this study we want to try to decrease side effects and shorten the course of radiation treatment for patients with cancer of their rectum by using a high-dose rate endorectal brachytherapy (HDRBT). This is a different form of radiation than what is normally given (CRT). With HDRBT, the radiation is given through an applicator placed into the bowel next to the tumor. The radiation is directed at the tumor and a small area around it.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-dose endorectal brachytherapy (HDRBT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HDRBT (High Dose Rectal Brachytherapy)
- description
- Radiation: High-dose endorectal brachytherapy The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer. A daily dose of 6.5 Gy over four consecutive days
- interventionNames
- Radiation: High-dose endorectal brachytherapy (HDRBT)
Primary outcomes (1)
- measure
- Number of Participants With Pathologic Complete Response
- timeFrame
- 8 weeks
- description
- Those participants whose surgical pathology indicated that they had a complete response measured by RECIST. Per Response Evaluation Criteria In Solid Tumors (RECISTv1.0). Complete response (CR) indicating no tumors, a partial (PR) response indicating at least a 30% decrease in tumor diameter (PR), progressive disease (PD) indicating 20% or greater increase in tumor diameter, and stable disease (SD) indicating that the tumor did not shrink significantly to be considered a partial response and did not grow significantly enough to be considered progressive disease.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically confirmed adenocarcinoma of the rectum * Able to undergo local staging of the rectal tumor performed by MRI and/or endoscopic ultrasonography (EUS) demonstrating a T2N1 or T3N0-1 tumor * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participants are willing to undergo initial therapy and if needed subsequent therapy prior to resection at Johns Hopkins Medical Institutions * English as a primary language in order to complete the quality of life questionnaires Exclusion Criteria: * Patients with tumors \>12 cm from the anal verge. * Near obstructing or bulky tumors which will not allow application of the endorectal probe * Patients with distant metastatic disease * Any pelvic lymph nodes outside of the mesorectum (iliac or inguinal) * Prior history of radiation therapy to the pelvis * Prior history of chemotherapy for rectal cancer * Active connective tissue disease such as scleroderma or Crohn's disease
References
Publications (0)
Data not yet available