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NCT04248582 · ClinicalTrials.gov registry record · Phase 1
Cryotherapy for Locally Advanced Esophageal Cancer
A Phase 1 study of Esophageal Cancer, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT04248582: Active Phase 1 study of Esophageal Cancer, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.
NCT04248582 is a Phase 1 study of Esophageal Cancer that is active but no longer recruiting, run by Hunter Holmes Mcguire Veteran Affairs Medical Center. The registered enrollment target is 14 participants, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04248582, a Phase 1 study of Esophageal Cancer, is active but no longer recruiting, sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: In published studies, complete response (CR) to chemoradiation occurs in only 25-30% of patients with locally advanced esophageal cancer. Liquid nitrogen spray cryotherapy (LNSC) is postulated to stimulate an anti-tumor immune response. In a preliminary study, the investigators documented CR rate of 56% with a single session of LNSC administered prior to chemoradiation. Before proceeding with larger trials to corroborate these findings, the maximally tolerated dose (MTD) of neoadjuvant LNSC must be determined. The aims of this study are: (1) To determine safety and MTD of LNSC during neoadjuvant chemoradiation in locally advanced esophageal cancer. (2) To assess whether LNSC results in immunogenic cell death. (3) To assess changes in tumor micro-environment with LNSC. Methods: Eligible adult patients with locally advanced esophageal cancer will receive LNSC at the following dose frequencies: Patient 1, 2, and 3: 2 sessions of LNSC prior to chemoradiation (chemoXRT); Patients 4, 5, and 6: 2 sessions LNSC prior to chemoXRT, then 1 session during week 4 of chemoXRT; Patients 7, 8, and 9: 2 sessions LNSC prior to chemoXRT, then 1 session during week 2 and 1 session during week 4 of chemoXRT. If no dose limiting toxicity (DLT) occurs, the investigators will enroll an additional 3 patients to confirm MTD. The investigators will contact patients at 48-hours and 1-week post-procedure to evaluate for adverse events (AEs) and DLTs, and assess for improvements in dysphagia and quality of life (QOL) using the Mellow-Pinkas and EORTC QLQ-OES18 instruments respectively. The investigators will obtain peripheral blood for ELISA and biopsies from the tumor to assess tumor-infiltrating lymphocytes (TILs) and T cell subtypes before the 1st session of LNSC, before the 2nd session of LNSC, and after chemoradiation is completed. Expected results: (1) Dose limiting toxicity (DLT) does not occur when patients received 2 session of LNSC prior to chemoXRT, and 2 sessions during
Primary Outcome
We hypothesize that 1) DLT will not occur when patients receive 2 sessions of LNSC prior to chemoradiation, and 2 sessions during chemoradiation (i.e. - a total of 4 sessions) for locally advanced esophageal cancer
Conditions Studied
Interventions
- DEVICE Cryotherapy
Study Locations (1)
Virginia
- Hunter Holmes McGuire VA Medical Center - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-02-11 |
| Est. Completion | 2025-07-01 |
| Phase | Phase 1 |
What the registry record for NCT04248582 still lists
NCT04248582 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 499-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Esophageal Cancer appearing as the primary indexed condition, and to 1 intervention - of which Cryotherapy is the first listed.
NCT04248582 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT04248582 about?
NCT04248582 is a clinical study titled "Cryotherapy for Locally Advanced Esophageal Cancer". Background: In published studies, complete response (CR) to chemoradiation occurs in only 25-30% of patients with locally advanced esophageal cancer. Liquid nitrogen spray cryotherapy (LNSC) is postulated to stimulate an anti-tumor immune response. In a preliminary study, the investigators documente...
What is the current status of trial NCT04248582?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2020-02-11. Estimated completion is 2025-07-01.
What conditions does trial NCT04248582 study?
This clinical trial studies the following conditions: Esophageal Cancer.
What interventions are being tested in trial NCT04248582?
The interventions under investigation include: Cryotherapy (DEVICE).
Who is sponsoring clinical trial NCT04248582?
This trial is sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04248582 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04248582's enrollment target sits among peer trials
14 116th of 123 higher than 8 of 123 other Esophageal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Cancer 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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