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NCT01862718 · ClinicalTrials.gov registry record · Phase 1
Fusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01862718 is a Phase 1 study that was terminated before completion, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 5 participants.
The verdict
NCT01862718, a Phase 1 study, was terminated before completion, sponsored by National Institutes of Health Clinical Center (CC).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation). Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver. High volume or scattered locations of tumor burden results in inability to successfully use this technology for a large proportion of patients with hepatic neoplasms. Methods to enhance treatment volumes could be advantageous in potentially increasing the indications for thermal ablation or the number of patients benefitting from local ablation. Primary objective: To determine the safety of combining 2 standard therapies (thermal ablation and external beam radiation therapy) for liver neoplasms up to 10 cm diameter. Eligibility: Patients greater than 18 years of age with pathologically proven unresectable primary or metastatic hepatic neoplasms Patients whose extent of hepatic metastases represents approximately less than 60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months Patients with a history of chemotherapy, radiation therapy, or biological therapy for at least 4 weeks prior to starting study treatments, and 4 weeks after treatments Patients must not have an acute, critical illness If clinical or imaging evidence for cirrhosis present, then Bilirubin must be less than 3 mg/dl and Child-Pugh Classification A, (Class B \& C are excluded) Design: Patients will undergo external beam radiation as well as thermal ablation according to standard operating procedures of the NCI and NIH CC. Patients will be monitored using the standard imaging studies when clinically warranted. Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is deemed beneficial for the patient by the investigator. The sample size will b
Interventions
- PROCEDURE Thermal Ablation
- PROCEDURE Standard External Beam Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-11-19 |
| Est. Completion | 2019-11-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01862718
The ClinicalTrials.gov registry entry for NCT01862718 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Thermal Ablation is the first listed.
NCT01862718 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01862718 about?
NCT01862718 is a clinical study titled "Fusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms". Background: Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation). Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver. High volume or s...
What is the current status of trial NCT01862718?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2013-11-19. Estimated completion is 2019-11-05.
What interventions are being tested in trial NCT01862718?
The interventions under investigation include: Thermal Ablation (PROCEDURE), Standard External Beam Radiation Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT01862718?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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