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NCT02199236 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Trial of Endoluminal High-Dose-Rate Brachytherapy With Concurrent Chemotherapy for Rectal or Anal Cancer in Patients With Recurrent Disease or Undergoing Non-Operative Management
A Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02199236: Completed Phase 1 study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT02199236 is a Phase 1 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02199236, a Phase 1 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is to see what amount of radiation is safe to give to rectal or anal cancer patients who are being treated with a procedure called brachytherapy.
Primary Outcome
will employ a standard 3+3 dose-escalation scheme. Patients will be accrued to the study in cohorts of 3. An initial cohort of 3 patients will be treated to each dose. The dose level will be escalated if none of the 3 patients exhibits any DLT within 90 days of completion of brachytherapy. Dose escalation will not take place until every patient in the prior dose cohort has been monitored for 90 days.
Interventions
- BEHAVIORAL Questionnaires
- RADIATION endorectal brachytherapy
- DRUG concurrent capecitabine or 5-FU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-07 |
| Est. Completion | 2024-10-29 |
| Phase | Phase 1 |
What the finished NCT02199236 record still lists
NCT02199236 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Questionnaires is the first listed.
NCT02199236 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02199236 about?
NCT02199236 is a clinical study titled "Dose Escalation Trial of Endoluminal High-Dose-Rate Brachytherapy With Concurrent Chemotherapy for Rectal or Anal Cancer in Patients With Recurrent Disease or Undergoing Non-Operative Management". The purpose of this study is to see what amount of radiation is safe to give to rectal or anal cancer patients who are being treated with a procedure called brachytherapy.
What is the current status of trial NCT02199236?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-07. Estimated completion is 2024-10-29.
What interventions are being tested in trial NCT02199236?
The interventions under investigation include: Questionnaires (BEHAVIORAL), endorectal brachytherapy (RADIATION), concurrent capecitabine or 5-FU (DRUG).
Who is sponsoring clinical trial NCT02199236?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02199236's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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