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NCT01612351 · ClinicalTrials.gov registry record · Phase 2
Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery
A Phase 2 study of Head and Neck Cancer and Squamous Cell Carcinoma of the Head and Neck, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT01612351: Completed Phase 2 study of Head and Neck Cancer and Squamous Cell Carcinoma of the Head and Neck, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT01612351 is a Phase 2 study of Head and Neck Cancer and Squamous Cell Carcinoma of the Head and Neck that has completed, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 40 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01612351, a Phase 2 study of Head and Neck Cancer and Squamous Cell Carcinoma of the Head and Neck, has completed, sponsored by UNC Lineberger Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to see if a three method risk adapted design using induction chemotherapy, transoral surgery and radiation chemotherapy will lessen toxic effects and make treatment of squamous cell carcinoma of the head and neck (SCCHN) better.
Primary Outcome
Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Overall response rate (ORR) is defined as the number of patients who have a partial or complete response to therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Cisplatin
- DRUG Paclitaxel
- DRUG Lapatinib
Study Locations (1)
North Carolina
- The University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-06 |
| Est. Completion | 2025-05-19 |
| Phase | Phase 2 |
What the finished NCT01612351 record still lists
NCT01612351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT01612351 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01612351 about?
NCT01612351 is a clinical study titled "Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery". The purpose of this study is to see if a three method risk adapted design using induction chemotherapy, transoral surgery and radiation chemotherapy will lessen toxic effects and make treatment of squamous cell carcinoma of the head and neck (SCCHN) better.
What is the current status of trial NCT01612351?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2012-06. Estimated completion is 2025-05-19.
What conditions does trial NCT01612351 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck.
What interventions are being tested in trial NCT01612351?
The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Paclitaxel (DRUG), Lapatinib (DRUG).
Who is sponsoring clinical trial NCT01612351?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01612351 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01612351's enrollment target sits among peer trials
40 142nd of 250 higher than 99 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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