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NCT00703976 · ClinicalTrials.gov registry record · Phase 2
Radiation, Cetuximab and Pemetrexed With or Without Bevacizumab in Locally Advanced Head and Neck Cancer
A Phase 2 study of Cancer, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT00703976: Completed Phase 2 study of Cancer, sponsored by University of Pittsburgh.
NCT00703976 is a Phase 2 study of Cancer that has completed, run by University of Pittsburgh. The registered enrollment target is 80 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00703976, a Phase 2 study of Cancer, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare the effects (good and bad) of chemoradiotherapy with or without Bevacizumab (Avastin). Chemoradiotherapy is the combination of chemotherapy (the drugs pemetrexed and cetuximab) and radiation. Pemetrexed is not approved by the Food and Drug Administration (FDA) for head and neck cancer when used in combination with radiation therapy. Cetuximab is also approved by the FDA for head and neck cancers in patients who have failed other chemotherapy treatments. Bevacizumab is approved by the Food and Drug Administration (FDA) for colorectal cancer and non-small cell lung cancer in combination of chemotherapy. In this study, the use of bevacizumab is investigational.
Primary Outcome
Two-year PFS is an estimated percentage of participants without disease progression (locoregional or distant) at two years after the start of study treatment. Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as: at least a 20% (and at least 5 millimeters) increase in the sum of the diameters of target lesions, or the appearance of one or more new lesions.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Pemetrexed
- DRUG Cetuximab
- RADIATION Radiation therapy
Study Locations (1)
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2008-10 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT00703976 record still lists
NCT00703976 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 4 interventions - of which Bevacizumab is the first listed.
NCT00703976 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00703976 about?
NCT00703976 is a clinical study titled "Radiation, Cetuximab and Pemetrexed With or Without Bevacizumab in Locally Advanced Head and Neck Cancer". The purpose of this study is to compare the effects (good and bad) of chemoradiotherapy with or without Bevacizumab (Avastin). Chemoradiotherapy is the combination of chemotherapy (the drugs pemetrexed and cetuximab) and radiation. Pemetrexed is not approved by the Food and Drug Administration (FDA)...
What is the current status of trial NCT00703976?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2008-10. Estimated completion is 2014-09.
What conditions does trial NCT00703976 study?
This clinical trial studies the following conditions: Cancer.
What interventions are being tested in trial NCT00703976?
The interventions under investigation include: Bevacizumab (DRUG), Pemetrexed (DRUG), Cetuximab (DRUG), Radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00703976?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00703976 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT00703976's enrollment target sits among peer trials
80 349th of 615 higher than 255 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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