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NCT01420250 · ClinicalTrials.gov registry record · Phase 1
Cabazitaxel With Radiation and Hormone Therapy for Prostate Cancer
A Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01420250: Completed Phase 1 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT01420250 is a Phase 1 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01420250, a Phase 1 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a single-center, open-label, non-randomized Phase I study of weekly Cabazitaxel with concurrent intensity modulated radiation therapy (IMRT) (A type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles.) and androgen deprivation therapy (Treatment to suppress or block the production or action of male hormones) in patients with locally advanced prostate cancer. It is hoped that by adding Cabazitaxel to the standard IMRT, greater local disease control can be achieved and eventually the cure rate can be increased. After this study, the maximally tolerated dose of Cabazitaxel that could be used in combination with radiation can be found. Men with locally advanced high risk prostate cancer represent a group of patients for whom cure is potentially achievable utilizing a multimodality approach. More aggressive treatment upfront with chemotherapy and ADT may improve the long term disease control. We hypothesize that Cabazitaxel may be added to radiation therapy safely, and we anticipate that this novel approach will improve disease control and eventually improve survival for locally advanced prostate cancer patients.
Primary Outcome
To determine the maximally tolerated dose, or the safety and feasibility, of the concurrent weekly Cabazitaxel and IMRT with androgen deprivation therapy
Interventions
- RADIATION Intensity Modulated Radiation Therapy (IMRT)
- DRUG Cabazitaxel
- DRUG Anti-Androgen Therapy: Bicalutamide
- GENETIC Luteinizing Hormone-Releasing Hormone (LHRH) Agonist
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-09-22 |
| Est. Completion | 2020-07-21 |
| Phase | Phase 1 |
What the finished NCT01420250 record still lists
NCT01420250 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 4 interventions - of which Intensity Modulated Radiation Therapy (IMRT) is the first listed.
NCT01420250 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01420250 about?
NCT01420250 is a clinical study titled "Cabazitaxel With Radiation and Hormone Therapy for Prostate Cancer". This is a single-center, open-label, non-randomized Phase I study of weekly Cabazitaxel with concurrent intensity modulated radiation therapy (IMRT) (A type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of diff...
What is the current status of trial NCT01420250?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2011-09-22. Estimated completion is 2020-07-21.
What interventions are being tested in trial NCT01420250?
The interventions under investigation include: Intensity Modulated Radiation Therapy (IMRT) (RADIATION), Cabazitaxel (DRUG), Anti-Androgen Therapy: Bicalutamide (DRUG), Luteinizing Hormone-Releasing Hormone (LHRH) Agonist (GENETIC).
Who is sponsoring clinical trial NCT01420250?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01420250's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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