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NCT03539198 · ClinicalTrials.gov registry record
Study of Proton SBRT and Immunotherapy for Recurrent/Progressive Locoregional or Metastatic Head and Neck Cancer
A clinical trial, sponsored by Mayo Clinic.
- Terminated
- Registry status
- 19
- Enrollment target
NCT03539198: Clinical Trial study, sponsored by Mayo Clinic.
NCT03539198 is a clinical trial that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03539198 was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- 19 participants
- Enrollment target
Study Summary
This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.
Primary Outcome
ORR is defined as the proportion of patients who achieved a best response of complete response (CR) or partial response (PR) using iRECIST 1.1 criteria, and will be evaluated for both the lesion(s) treated with SBRT, referred to as "Target lesion (+SBRT+Nivo), as well as the lesion(s) not treated with SBRT (if applicable), referred to as "Target lesion (+Nivo only)", per the prescribed treatment. The primary endpoint for the locoregional arm will be considered met if the assumption and desired o
Interventions
- RADIATION Proton Stereotactic Body Radiation Therapy (SBRT) (5 fractions; 3500-4500 cGy)
- RADIATION Proton Stereotactic Body Radiation Therapy (SBRT) (3-5 fractions; various dose and fractionation regimens depending on treatment site).
- DRUG Nivolumab 3 mg/kg IV q2 weeks
- RADIATION Proton or Photon SBRT (3-5 fractions; various dose and fractionation regimens depending on treatment site).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-07-03 |
| Est. Completion | 2020-01-06 |
Why NCT03539198 stopped before completion
NCT03539198 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 19 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Proton Stereotactic Body Radiation Therapy (SBRT) (5 fractions; 3500-4500 cGy) is the first listed.
NCT03539198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03539198 about?
NCT03539198 is a clinical study titled "Study of Proton SBRT and Immunotherapy for Recurrent/Progressive Locoregional or Metastatic Head and Neck Cancer". This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.
What is the current status of trial NCT03539198?
This trial is currently terminated. The enrollment target is 19 participants. The study started on 2018-07-03. Estimated completion is 2020-01-06.
What interventions are being tested in trial NCT03539198?
The interventions under investigation include: Proton Stereotactic Body Radiation Therapy (SBRT) (5 fractions; 3500-4500 cGy) (RADIATION), Proton Stereotactic Body Radiation Therapy (SBRT) (3-5 fractions; various dose and fractionation regimens depending on treatment site). (RADIATION), Nivolumab 3 mg/kg IV q2 weeks (DRUG), Proton or Photon SBRT (3-5 fractions; various dose and fractionation regimens depending on treatment site). (RADIATION).
Who is sponsoring clinical trial NCT03539198?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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