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NCT05830058 · ClinicalTrials.gov registry record · Phase 2
Positron Emission Tomography (PET) Guided Stereotactic Body Radiation Therapy for the Treatment of Oligoprogressive Non-small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma
A Phase 2 study of Melanoma and Malignant Solid Neoplasm, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT05830058: Recruiting Phase 2 study of Melanoma and Malignant Solid Neoplasm, sponsored by City of Hope Medical Center.
NCT05830058 is a Phase 2 study of Melanoma and Malignant Solid Neoplasm that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 32 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05830058, a Phase 2 study of Melanoma and Malignant Solid Neoplasm, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests the safety of positron emission tomography (PET) guided stereotactic body radiation therapy (SBRT) and how well it works to treat non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma (RCC) that has up to 5 sites of progression (oligoprogression) compared to standard SBRT. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. A PET scan is an imaging test that looks at your tissues and organs using a small amount of a radioactive substance. It also checks for cancer and may help find cancer remaining in areas already treated. Using a PET scan for SBRT planning may help increase the dose of radiation given to the most resistant part of the cancer in patients with oligoprogressive NSCLC, melanoma, and RCC.
Primary Outcome
Feasibility and safety of biologically-guided adaptive planning based on the standardized uptake value (SUV) on pre-treatment and inter-fraction FDG-PET/CT to guide SBRT dose-escalation with a simultaneous integrated boost (SIB) delivered to areas of higher activity in patients with oligoprogressive (1-5 sites) disease when compared to the current standard SBRT planning without inter-fraction adaptive planning, with the goal of demonstrating that PET-adaptive inter-fraction planning can improve
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- RADIATION Stereotactic Body Radiation Therapy
- OTHER Questionnaire Administration
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2023-11-29 |
| Est. Completion | 2027-02-03 |
| Phase | Phase 2 |
What NCT05830058 shows while recruiting
NCT05830058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (95% lower).
The record links to 4 conditions, with Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05830058 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05830058 about?
NCT05830058 is a clinical study titled "Positron Emission Tomography (PET) Guided Stereotactic Body Radiation Therapy for the Treatment of Oligoprogressive Non-small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma". This phase II trial tests the safety of positron emission tomography (PET) guided stereotactic body radiation therapy (SBRT) and how well it works to treat non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma (RCC) that has up to 5 sites of progression (oligoprogression) compared t...
What is the current status of trial NCT05830058?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2023-11-29. Estimated completion is 2027-02-03.
What conditions does trial NCT05830058 study?
This clinical trial studies the following conditions: Melanoma, Malignant Solid Neoplasm, Renal Cell Carcinoma, Lung Non-Small Cell Carcinoma.
What interventions are being tested in trial NCT05830058?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), Stereotactic Body Radiation Therapy (RADIATION), Questionnaire Administration (OTHER).
Who is sponsoring clinical trial NCT05830058?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05830058 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05830058's enrollment target sits among peer trials
32 193rd of 266 higher than 72 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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.
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