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NCT01592721 · ClinicalTrials.gov registry record · Phase 1
Radiation and Cetuximab Plus Intratumoral EGFR Antisense DNA in Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 1 study of Head and Neck Cancer and Squamous Cell Carcinoma, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 2
- Study locations
NCT01592721: Completed Phase 1 study of Head and Neck Cancer and Squamous Cell Carcinoma, sponsored by The University of Texas Health Science Center at San Antonio.
NCT01592721 is a Phase 1 study of Head and Neck Cancer and Squamous Cell Carcinoma that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 6 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01592721, a Phase 1 study of Head and Neck Cancer and Squamous Cell Carcinoma, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 2
- Study locations
Study Summary
The incorporation of novel targeted therapies to radiation therapy is of particular interest in head and neck cancer and may improve efficacy without significantly increasing toxicity. The investigators hypothesize that the addition of a second EGFR-targeted agent that inhibits EGFR at the intracellular level will improve the antitumor effect of standard radiation and cetuximab. The goal of this study is to evaluate the safety, efficacy, and the biologic effects in patients with locally advanced SCCHN of an antisense gene targeting the EGFR in combination with standard therapy with radiation and cetuximab.
Primary Outcome
This is a 2-stage clinical trial. In the first stage, toxicity will be the primary endpoint. Toxicity measures will be graded according to NCI CTCAE version 4.0. All AEs reported are grade 1 to grade 3 AEs.
Conditions Studied
Interventions
- BIOLOGICAL EGFR Antisense DNA
Study Locations (2)
Pennsylvania
- University of Pittsburgh - Pittsburgh
Texas
- Cancer Therapy and Research Center at UTHSCSA - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-04 |
| Est. Completion | 2022-02-01 |
| Phase | Phase 1 |
What the finished NCT01592721 record still lists
NCT01592721 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which EGFR Antisense DNA is the first listed.
NCT01592721 reports a single indexed study location in Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT01592721 about?
NCT01592721 is a clinical study titled "Radiation and Cetuximab Plus Intratumoral EGFR Antisense DNA in Locally Advanced Head and Neck Squamous Cell Carcinoma". The incorporation of novel targeted therapies to radiation therapy is of particular interest in head and neck cancer and may improve efficacy without significantly increasing toxicity. The investigators hypothesize that the addition of a second EGFR-targeted agent that inhibits EGFR at the intracell...
What is the current status of trial NCT01592721?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2013-04. Estimated completion is 2022-02-01.
What conditions does trial NCT01592721 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Squamous Cell Carcinoma.
What interventions are being tested in trial NCT01592721?
The interventions under investigation include: EGFR Antisense DNA (BIOLOGICAL).
Who is sponsoring clinical trial NCT01592721?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01592721 being conducted?
This trial has 2 study locations across Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01592721's enrollment target sits among peer trials
6 242nd of 250 higher than 8 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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