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NCT04391049 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of the Anti-cancer Viral Therapy Telomelysin™ to Chemoradiation for Patients With Advanced Esophageal Cancer and Are Not Candidates for Surgery
A Phase 1 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage III Esophageal Adenocarcinoma AJCC v8, sponsored by NRG Oncology.
- Active
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 17
- Study locations
NCT04391049: Active Phase 1 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage III Esophageal Adenocarcinoma AJCC v8, sponsored by NRG Oncology.
NCT04391049 is a Phase 1 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage III Esophageal Adenocarcinoma AJCC v8 that is active but no longer recruiting, run by NRG Oncology. The registered enrollment target is 16 participants, below the 97-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (84% lower). The trial reports 17 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04391049, a Phase 1 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage III Esophageal Adenocarcinoma AJCC v8, is active but no longer recruiting, sponsored by NRG Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
Adverse events are graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, which grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. A DLT is defined as the following that are definitely or probably attributed to OBP-301: * Any grade ≥3 adverse event EXCEPT for the following: * Grade 3 nausea/vomiting * Grade 3 esophagitis or dehydration * The first occurrence of grade 3/4
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 |
What the registry record for NCT04391049 still lists
NCT04391049 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 97-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (84% lower).
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.
NCT04391049 lists 17 locations in 8 states (New York, California, Kansas).
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.
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).
Who is sponsoring clinical trial NCT04391049?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT04391049's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 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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