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NCT03690921 · ClinicalTrials.gov registry record · Phase 2
Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT) as a Component of Definitive Chemoradiation for Newly Diagnosed Squamous Cell Carcinoma of the Anal Canal: a Feasibility Trial
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT03690921: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT03690921 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03690921, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
This phase II trial studies the side effects of LET-IMPT and standard chemotherapy, and how well they work in treating patients with newly diagnosed stage I-III anal canal squamous cell cancer. LET-IMPT is a type of radiation therapy that uses high energy proton "beamlets" to "paint" the radiation dose into the target and may help to kill tumor cells and shrink tumors. Giving LET-IMPT and standard chemotherapy may work better in treating patients with anal canal squamous cell cancer.
Primary Outcome
Number (percentage) of patients with physician-reported acute G3+ GI, GU and heme toxicities
Interventions
- DRUG Cisplatin
- DRUG Fluorouracil
- OTHER Questionnaire Administration
- PROCEDURE Quality-of-Life Assessment
- RADIATION Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-11-08 |
| Est. Completion | 2022-06-03 |
| Phase | Phase 2 |
What the finished NCT03690921 record still lists
NCT03690921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT03690921 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03690921 about?
NCT03690921 is a clinical study titled "Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT) as a Component of Definitive Chemoradiation for Newly Diagnosed Squamous Cell Carcinoma of the Anal Canal: a Feasibility Trial". This phase II trial studies the side effects of LET-IMPT and standard chemotherapy, and how well they work in treating patients with newly diagnosed stage I-III anal canal squamous cell cancer. LET-IMPT is a type of radiation therapy that uses high energy proton "beamlets" to "paint" the radiation d...
What is the current status of trial NCT03690921?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2018-11-08. Estimated completion is 2022-06-03.
What interventions are being tested in trial NCT03690921?
The interventions under investigation include: Cisplatin (DRUG), Fluorouracil (DRUG), Questionnaire Administration (OTHER), Quality-of-Life Assessment (PROCEDURE), Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy (RADIATION).
Who is sponsoring clinical trial NCT03690921?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03690921's enrollment target sits among peer trials
8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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