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NCT01307956 · ClinicalTrials.gov registry record · Phase 2
Panitumumab, Combination Chemotherapy, & Radiation Therapy in Esophageal or Gastroesophageal Junction Cancer
A Phase 2 study, sponsored by University of Nebraska.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT01307956: Clinical Trial Phase 2 study, sponsored by University of Nebraska.
NCT01307956 is a Phase 2 study that was terminated before completion, run by University of Nebraska. The registered enrollment target is 11 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01307956, a Phase 2 study, was terminated before completion, sponsored by University of Nebraska.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
This phase II trial is studying how well giving panitumumab, combination chemotherapy, and radiation therapy together before surgery works in treating patients with advanced esophageal or gastroesophageal (GE) junction cancer. Monoclonal antibodies, such as panitumumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells. Giving monoclonal antibody therapy together with chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Primary Outcome
Based on the proportion who achieve pCR based on the first 4 courses of protocol treatment. Evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 guidelines. Means (with associated standard errors), medians (with ranges), percentages and 95% confidence intervals will be reported as appropriate.
Interventions
- DRUG Fluorouracil
- DRUG Oxaliplatin
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Panitumumab
- DRUG Leucovorin Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-02-28 |
| Est. Completion | 2015-12-23 |
| Phase | Phase 2 |
Why NCT01307956 stopped before completion
NCT01307956 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 5 interventions - of which Fluorouracil is the first listed.
NCT01307956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01307956 about?
NCT01307956 is a clinical study titled "Panitumumab, Combination Chemotherapy, & Radiation Therapy in Esophageal or Gastroesophageal Junction Cancer". This phase II trial is studying how well giving panitumumab, combination chemotherapy, and radiation therapy together before surgery works in treating patients with advanced esophageal or gastroesophageal (GE) junction cancer. Monoclonal antibodies, such as panitumumab, may interfere with the abilit...
What is the current status of trial NCT01307956?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2011-02-28. Estimated completion is 2015-12-23.
What interventions are being tested in trial NCT01307956?
The interventions under investigation include: Fluorouracil (DRUG), Oxaliplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Panitumumab (BIOLOGICAL), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT01307956?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01307956's enrollment target sits among peer trials
11 1967th of 2000 higher than 33 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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