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NCT00766636 · ClinicalTrials.gov registry record · Phase 2
Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00766636: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00766636 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00766636, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Primary Objective: To assess margin positive resection rate (R1 resection rate; defined as "tumor within 2 mm of surgical margin on final pathology report") in patients treated with preoperative chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy followed by pancreaticoduodenectomy for adenocarcinoma of the pancreatic head. Secondary Objectives: * To assess disease free survival * To assess overall survival * To assess patterns of local and distant failure
Primary Outcome
Difference in positive margin resection (R1) rate in patients who undergo surgery between the two treatment groups. Margin resection rate is defined as number of patients with R1 margin divided by the total number of patients who received surgery in that arm. Eligible patients will be equally (1:1 ratio) randomized to one of the two arms to receive either Gemcitabine and Erlotinib or Gemcitabine and Erlotinib and radiation as preoperative therapy. Surgery to be performed approximately 4 weeks af
Interventions
- RADIATION Radiation Therapy
- DRUG Gemcitabine
- PROCEDURE Surgery
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2008-09 |
| Phase | Phase 2 |
Why NCT00766636 stopped before completion
NCT00766636 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 4 interventions - of which Radiation Therapy is the first listed.
NCT00766636 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00766636 about?
NCT00766636 is a clinical study titled "Preoperative Chemotherapy (Gemcitabine and Erlotinib) With or Without Radiation Therapy". Primary Objective: To assess margin positive resection rate (R1 resection rate; defined as "tumor within 2 mm of surgical margin on final pathology report") in patients treated with preoperative chemotherapy (gemcitabine and erlotinib) with or without external-beam radiation therapy followed by pan...
What is the current status of trial NCT00766636?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2008-09.
What interventions are being tested in trial NCT00766636?
The interventions under investigation include: Radiation Therapy (RADIATION), Gemcitabine (DRUG), Surgery (PROCEDURE), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT00766636?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00766636's enrollment target sits among peer trials
5 2000th 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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