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NCT01386632 · ClinicalTrials.gov registry record · Phase 2
Study of DCA (Dichloroacetate) in Combination With Cisplatin and Definitive Radiation in Head and Neck Carcinoma
A Phase 2 study, sponsored by Sanford Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01386632: Completed Phase 2 study, sponsored by Sanford Health.
NCT01386632 is a Phase 2 study that has completed, run by Sanford Health. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01386632, a Phase 2 study, has completed, sponsored by Sanford Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
This will be a randomized masked placebo-controlled single-center study to evaluate the effects of Dichloroacetate (DCA) versus placebo given in combination with Cisplatin and radiation treatment in patients with Stage III-IV Squamous Cell Carcinoma of the Head and Neck (SCCHN). Fifty subjects will be enrolled and randomly assigned on a 1:1 ratio to DCA or matching placebo given with standard of care treatment consisting of Cisplatin and radiation treatment. Patients will receive DCA/placebo PO or per G-tube twice a day for 8 weeks. The first 6 patients of the total study population will represent a safety lead-in cohort. The results of the safety lead-in of DCA/placebo in combination with Cisplatin and radiation therapy will be evaluated after the 6th patient has completed 8 weeks of therapy. Recruitment of patients will be withheld during safety data analysis.
Primary Outcome
Percentage of Participants Who Experienced Adverse Events During Treatment including but are not limited to mucositis, leucopenia, neuropathy, and treatment breaks. This will be done according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Interventions
- DRUG Placebo
- DRUG DCA (dichloroacetate)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-05 |
| Est. Completion | 2020-06-01 |
| Phase | Phase 2 |
What the finished NCT01386632 record still lists
NCT01386632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01386632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01386632 about?
NCT01386632 is a clinical study titled "Study of DCA (Dichloroacetate) in Combination With Cisplatin and Definitive Radiation in Head and Neck Carcinoma". This will be a randomized masked placebo-controlled single-center study to evaluate the effects of Dichloroacetate (DCA) versus placebo given in combination with Cisplatin and radiation treatment in patients with Stage III-IV Squamous Cell Carcinoma of the Head and Neck (SCCHN). Fifty subjects will ...
What is the current status of trial NCT01386632?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2011-05. Estimated completion is 2020-06-01.
What interventions are being tested in trial NCT01386632?
The interventions under investigation include: Placebo (DRUG), DCA (dichloroacetate) (DRUG).
Who is sponsoring clinical trial NCT01386632?
This trial is sponsored by Sanford Health, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01386632's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 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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