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NCT02158234 · ClinicalTrials.gov registry record · Phase 1
Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck
A Phase 1 study of Squamous Cell Carcinoma of the Head and Neck, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02158234: Completed Phase 1 study of Squamous Cell Carcinoma of the Head and Neck, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT02158234 is a Phase 1 study of Squamous Cell Carcinoma of the Head and Neck that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 20 participants, below the 145-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02158234, a Phase 1 study of Squamous Cell Carcinoma of the Head and Neck, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study involves another course of radiation (called re-irradiation) to the participant's tumor. The type of radiation is called stereotactic body radiation therapy (SBRT). The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given along with the chemotherapy drug, cisplatin. The researchers want to see which dose of radiation will work best in controlling the growth of head/neck cancer. The usual treatment for head/neck cancer that has grown is surgery and/or more radiation with various chemotherapy drugs.
Primary Outcome
The traditional 3+3 dose escalation method will be utilized for this phase I study, with up to 3 sequential cohorts. The maximal tolerated dose (MTD) of Stereotactic Body Radiation Therapy (SBRT) radiation dose associated with a ≤ 33% probability of dose-limiting toxicity (DLT). DLT is defined as any grade 4 or greater toxicity, per The Common Terminology Criteria for Adverse Events v4 (CTCAE v4) that occurs within 3 months from the start of SBRT.
Conditions Studied
Interventions
- DRUG Cisplatin
- RADIATION Stereotactic Body Radiation Therapy (SBRT)
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-07-16 |
| Est. Completion | 2021-08-24 |
| Phase | Phase 1 |
What the finished NCT02158234 record still lists
NCT02158234 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 145-participant average among 29 other Squamous Cell Carcinoma of the Head and Neck trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Squamous Cell Carcinoma of the Head and Neck appearing as the primary indexed condition, and to 2 interventions - of which Cisplatin is the first listed.
NCT02158234 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT02158234 about?
NCT02158234 is a clinical study titled "Stereotactic Body Radiotherapy and Concurrent Cisplatin for Re-Irradiation of Unresectable, Recurrent Squamous Cell Carcinomas of Head and Neck". This study involves another course of radiation (called re-irradiation) to the participant's tumor. The type of radiation is called stereotactic body radiation therapy (SBRT). The purpose of this study is to compare the effects, good and/or bad, of different doses of SBRT given along with the chemot...
What is the current status of trial NCT02158234?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2014-07-16. Estimated completion is 2021-08-24.
What conditions does trial NCT02158234 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of the Head and Neck.
What interventions are being tested in trial NCT02158234?
The interventions under investigation include: Cisplatin (DRUG), Stereotactic Body Radiation Therapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT02158234?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02158234 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02158234's enrollment target sits among peer trials
20 26th of 29 higher than 4 of 29 other Squamous Cell Carcinoma of the Head and Neck trials
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