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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 is a Phase 2 study that has completed, run by Sanford Health. The registered enrollment target is 50 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01386632
The ClinicalTrials.gov registry entry for NCT01386632 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanford Health, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01386632 reports 0 study locations.
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.
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