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NCT01927744 · ClinicalTrials.gov registry record · Phase 2
Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection
A Phase 2 study of Head and Neck Cancer, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT01927744: Completed Phase 2 study of Head and Neck Cancer, sponsored by M.D. Anderson Cancer Center.
NCT01927744 is a Phase 2 study of Head and Neck Cancer that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 55 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01927744, a Phase 2 study of Head and Neck Cancer, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical research study is to learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied. In this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. This is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin, and carboplatin are all FDA approved and commercially available for the treatment of SCCHN. Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Primary Outcome
Major Pathologic Response (MPR) was defined as ≤ 10% residual biable tumor cells in the resected primary tumor specimen following completion of neadjuvant therapy.
Conditions Studied
Interventions
- DRUG Docetaxel
- OTHER Placebo
- BEHAVIORAL Questionnaires
- DRUG Erlotinib
- BEHAVIORAL Phone Call
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2013-12-16 |
| Est. Completion | 2025-01-06 |
| Phase | Phase 2 |
What the finished NCT01927744 record still lists
NCT01927744 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 5 interventions - of which Docetaxel is the first listed.
NCT01927744 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01927744 about?
NCT01927744 is a clinical study titled "Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection". The goal of this clinical research study is to learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied. In this study, erlotinib will be compared to a placebo...
What is the current status of trial NCT01927744?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2013-12-16. Estimated completion is 2025-01-06.
What conditions does trial NCT01927744 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT01927744?
The interventions under investigation include: Docetaxel (DRUG), Placebo (OTHER), Questionnaires (BEHAVIORAL), Erlotinib (DRUG), Phone Call (BEHAVIORAL).
Who is sponsoring clinical trial NCT01927744?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01927744 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01927744's enrollment target sits among peer trials
55 123rd of 250 higher than 127 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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.
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