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NCT01192815 · ClinicalTrials.gov registry record · Phase 2
Erlotinib Hydrochloride and Radiation Therapy in Stage III-IV Squamous Cell Cancer of the Head and Neck
A Phase 2 study, sponsored by Case Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01192815: Clinical Trial Phase 2 study, sponsored by Case Comprehensive Cancer Center.
NCT01192815 is a Phase 2 study that was terminated before completion, run by Case Comprehensive Cancer Center. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01192815, a Phase 2 study, was terminated before completion, sponsored by Case Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib hydrochloride may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x- rays and other types of radiation to kill tumor cells. Giving erlotinib hydrochloride together with radiation therapy may be an effective treatment for patients with head and neck cancer.PURPOSE: This phase II trial is studying how well giving erlotinib hydrochloride together with radiation therapy works in treating patients with stage III-IV squamous cell cancer of the head and neck.
Primary Outcome
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started. Disease progression free survival (PFS) is measured from start of treatment to the date of disease progression or protocol-designated outcome, whichever occurs first and censored at the date of last fo
Interventions
- RADIATION intensity-modulated radiation therapy
- OTHER pharmacogenomic studies
- RADIATION 3-dimensional conformal radiation therapy
- DRUG erlotinib hydrochloride
- OTHER gene expression analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-10 |
| Phase | Phase 2 |
Why NCT01192815 stopped before completion
NCT01192815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which intensity-modulated radiation therapy is the first listed.
NCT01192815 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01192815 about?
NCT01192815 is a clinical study titled "Erlotinib Hydrochloride and Radiation Therapy in Stage III-IV Squamous Cell Cancer of the Head and Neck". RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Erlotinib hydrochloride may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x- rays and other types of radiation to kill tumor c...
What is the current status of trial NCT01192815?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2011-01. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01192815?
The interventions under investigation include: intensity-modulated radiation therapy (RADIATION), pharmacogenomic studies (OTHER), 3-dimensional conformal radiation therapy (RADIATION), erlotinib hydrochloride (DRUG), gene expression analysis (OTHER).
Who is sponsoring clinical trial NCT01192815?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01192815's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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