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Testing the Addition of the Anti-cancer Viral Therapy Telomelysin™ to Chemoradiation for Patients With Advanced Esophageal Cancer and Are Not Candidates for Surgery
NCT04391049 · View on ClinicalTrials.gov ↗
Study Summary
This phase I trial studies the side effects of OBP-301 when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal or gastroesophageal cancer that invades local or regional structures. OBP-301 is a virus that has been designed to infect and destroy tumor cells (although there is a small risk that it can also infect normal cells). Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving OBP-301 with chemotherapy and radiation therapy may work better than standard chemotherapy and radiation therapy in treating patients with esophageal or gastroesophageal cancer.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- RADIATION Radiation Therapy
- BIOLOGICAL Telomerase-specific Type 5 Adenovirus OBP-301
Study Locations (17)
New York
- Memorial Sloan Kettering Commack — Commack
- Memorial Sloan Kettering Westchester — Harrison
- Memorial Sloan Kettering Cancer Center — New York
- Memorial Sloan Kettering Nassau — Uniondale
California
- City of Hope Comprehensive Cancer Center — Duarte
- City of Hope South Pasadena — South Pasadena
- City of Hope Upland — Upland
Kansas
- University of Kansas Clinical Research Center — Fairway
- University of Kansas Cancer Center — Kansas City
- University of Kansas Hospital-Westwood Cancer Center — Westwood
New Jersey
- Memorial Sloan Kettering Basking Ridge — Basking Ridge
- Memorial Sloan Kettering Monmouth — Middletown
- Memorial Sloan Kettering Bergen — Montvale
Florida
- Moffitt Cancer Center — Tampa
Massachusetts
- Massachusetts General Hospital Cancer Center — Boston
Ohio
- Ohio State University Comprehensive Cancer Center — Columbus
Texas
- M D Anderson Cancer Center — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-12-02 |
| Est. Completion | 2026-10-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04391049
The ClinicalTrials.gov registry entry for NCT04391049 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NRG Oncology, which has 162 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 appearing as the primary indexed condition, and to 4 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04391049 reports 17 study locations spanning 8 distinct geographic areas — top geographies include New York, California, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04391049 about?
NCT04391049 is a clinical study titled "Testing the Addition of the Anti-cancer Viral Therapy Telomelysin™ to Chemoradiation for Patients With Advanced Esophageal Cancer and Are Not Candidates for Surgery". This phase I trial studies the side effects of OBP-301 when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal or gastroesophageal cancer that invades local or regional structures. OBP-301 is a virus that has been designed to infect and destroy tu...
What is the current status of trial NCT04391049?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2021-12-02. Estimated completion is 2026-10-01.
What conditions does trial NCT04391049 study?
This clinical trial studies the following conditions: Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Advanced Gastroesophageal Junction Adenocarcinoma, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04391049?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Radiation Therapy (RADIATION), Telomerase-specific Type 5 Adenovirus OBP-301 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04391049?
This trial is sponsored by NRG Oncology, which has 162 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04391049 being conducted?
This trial has 17 study locations across California, Florida, Kansas, Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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