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NCT01783587 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT01783587 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 29 participants.
The verdict
NCT01783587, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use and the side effects it may cause. Afatinib has been studied in other clinical trials of participants with head and neck cancer, lung cancer, and breast cancer. This dose of Afatinib has also been studied in other research studies. This is the first clinical trial to study Afatinib in combination with Radiation Therapy. The purpose of this study is to determine the safest dose of Afatinib when given in combination with Radiation Therapy or in combination with Radiation Therapy and chemotherapy for head and neck cancer. Afatinib is a drug that may stop cancer cells from growing abnormally. This drug works by blocking multiple proteins known to play a role in the growth of cancer cells. Information from laboratory research studies suggests that this drug may help to make head and neck cancer cells more sensitive to Radiation Therapy. The other therapy in this research study is Radiation Therapy or Radiation Therapy plus a chemotherapy drug called Docetaxel. After surgery, Radiation Therapy and chemotherapy is the standard treatment if you have high risk disease. "High risk disease" means that without additional therapy, there is a high risk that the disease may return. In this study, participants with high-risk disease will receive Radiation Therapy and Docetaxel and Afatinib. "Intermediate risk" means that there is an intermediate risk that the disease may return. Radiation Therapy alone is the standard treatment approach for intermediate risk cancer. In this study, participants with intermediate risk disease will receive Radiation Therapy and Afatinib.
Interventions
- DRUG Docetaxel
- RADIATION Radiation Therapy
- DRUG Afatinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2013-02 |
| Est. Completion | 2018-06-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01783587
The ClinicalTrials.gov registry entry for NCT01783587 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Docetaxel is the first listed.
NCT01783587 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01783587 about?
NCT01783587 is a clinical study titled "Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer". This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that r...
What is the current status of trial NCT01783587?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2013-02. Estimated completion is 2018-06-01.
What interventions are being tested in trial NCT01783587?
The interventions under investigation include: Docetaxel (DRUG), Radiation Therapy (RADIATION), Afatinib (DRUG).
Who is sponsoring clinical trial NCT01783587?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
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