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NCT01921751 · ClinicalTrials.gov registry record · Phase 2
High or Standard Intensity Radiation Therapy After Gemcitabine Hydrochloride and Nab-paclitaxel in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery
A Phase 2 study, sponsored by Radiation Therapy Oncology Group.
- Terminated
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01921751: Clinical Trial Phase 2 study, sponsored by Radiation Therapy Oncology Group.
NCT01921751 is a Phase 2 study that was terminated before completion, run by Radiation Therapy Oncology Group. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01921751, a Phase 2 study, was terminated before completion, sponsored by Radiation Therapy Oncology Group.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well high or standard intensity radiochemotherapy after gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) work compared with gemcitabine hydrochloride and nab-paclitaxel alone in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and nab-paclitaxel, 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. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Giving radiation therapy in different ways and adding chemotherapy may kill more tumor cells. It is not yet known whether high intensity radiochemotherapy after gemcitabine hydrochloride and nab-paclitaxel is more effective than standard intensity radiochemotherapy after gemcitabine hydrochloride and nab-paclitaxel or gemcitabine hydrochloride and nab-paclitaxel alone in treating pancreatic cancer.
Primary Outcome
Survival time is defined as time from randomization to date of death from any cause and was to be estimated by the Kaplan-Meier method. Given the limited follow-up due to early closure and termination of data collection, only the number of patients last reported to be alive at time of study termination is reported.
Interventions
- DRUG Capecitabine
- DRUG Gemcitabine
- DRUG nab-Paclitaxel
- RADIATION low intensity radiation therapy
- RADIATION high intensity radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
Why NCT01921751 stopped before completion
NCT01921751 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 5 interventions - of which Capecitabine is the first listed.
NCT01921751 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01921751 about?
NCT01921751 is a clinical study titled "High or Standard Intensity Radiation Therapy After Gemcitabine Hydrochloride and Nab-paclitaxel in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery". This randomized phase II trial studies how well high or standard intensity radiochemotherapy after gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) work compared with gemcitabine hydrochloride and nab-paclitaxel alone in treating patients with pan...
What is the current status of trial NCT01921751?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2013-08. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01921751?
The interventions under investigation include: Capecitabine (DRUG), Gemcitabine (DRUG), nab-Paclitaxel (DRUG), low intensity radiation therapy (RADIATION), high intensity radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT01921751?
This trial is sponsored by Radiation Therapy Oncology Group, which has 144 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01921751's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 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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