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NCT00798655 · ClinicalTrials.gov registry record · Phase 2
Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer
A Phase 2 study, sponsored by Robert Ferris.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT00798655: Completed Phase 2 study, sponsored by Robert Ferris.
NCT00798655 is a Phase 2 study that has completed, run by Robert Ferris. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00798655, a Phase 2 study, has completed, sponsored by Robert Ferris.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
The objectives for this study is as follows: * Primary: * To evaluate the progression-free survival of locoregionally advanced (stages III/IV) SCCHN patients undergoing postoperative chemoradiotherapy with panitumumab. * Secondary: * To evaluate the overall survival, event-free survival, and toxicities. * To correlate efficacy parameters with 1) EGFR and downstream pathway activation, 2) FcyR polymorphisms, and 3) serum cytokine profiles. More specifically, the aim is to demonstrate the usefulness of biomarkers (downstream signaling molecules, FcyR polymorphisms, or tumor and serum cytokine(s) in predicting progression-free survival in patients with SCCHN treated with the above treatment. Specific biomarkers that relate to Epidermal Growth Factor Receptor and angiogenesis, including EGFR, pEGFR, Src, pMAPK, pSTAT3, pSTAT5, pSTAT1, pAKT, p38, p21, p27, PARP, E-cadherin, p-ErbB3, Ki67, VEGF, and IL-8, using reverse phase protein microarrays (RPPA) will be tested in baseline archival paraffin-embedded tumor tissue. To collect tumor tissue from pretreatment biopsies for cytokine/chemokine and immune biomarker studies on tumor tissue. We plan to investigate the expression of pAKT, pMAPK, and other EGFR pathway-related markers as well angiogenesis biomarkers. In addition, EGFR polymorphisms will be studied in tumor tissue samples and serum. Additional studies may be performed in the future. Some of these studies may be performed by Amgen.
Interventions
- DRUG Cisplatin
- RADIATION Radiation Therapy
- DRUG Panitumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2007-11 |
| Est. Completion | 2016-11-09 |
| Phase | Phase 2 |
What the finished NCT00798655 record still lists
NCT00798655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT00798655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00798655 about?
NCT00798655 is a clinical study titled "Trial of Postoperative Radiation, Cisplatin, and Panitumumab in Locally Advanced Head and Neck Cancer". The objectives for this study is as follows: * Primary: * To evaluate the progression-free survival of locoregionally advanced (stages III/IV) SCCHN patients undergoing postoperative chemoradiotherapy with panitumumab. * Secondary: * To evaluate the overall survival, event-free survival, and ...
What is the current status of trial NCT00798655?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2007-11. Estimated completion is 2016-11-09.
What interventions are being tested in trial NCT00798655?
The interventions under investigation include: Cisplatin (DRUG), Radiation Therapy (RADIATION), Panitumumab (DRUG).
Who is sponsoring clinical trial NCT00798655?
This trial is sponsored by Robert Ferris, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00798655's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 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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