N/A
N=16
Study of High-Dose-Rate Endorectal Brachytherapy (HDRBT) in the Treatment of Locally Advanced Low Rectal Cancer
Rectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01226979 ↗Enrolled (actual)
16
Serious AEs
18.8%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants With Pathologic Complete Response — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High-dose endorectal brachytherapy (HDRBT) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pathologic Complete Response |
5 | — |
| SECONDARY Number of Participants With Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT) Brachytherapy |
1; 13; 0; 1 | — |
| SECONDARY Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores |
47.5; 50; 52.23; 64.33; 62.03; 59.27 | — |
| SECONDARY Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores |
40.63; 36.8; 42.08; 42; 48.72; 47.8 | — |
| SECONDARY Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores |
34.56; 32.3; 37.46; 34; 41.78; 42.6 | — |
| SECONDARY Number of Participants With Acute Gastrointestinal Toxicity Associated With High-Dose-Rate Endorectal Brachytherapy (HDRBT) as Assessed by CTCAE v4.0 |
2; 1 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01226979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.