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NCT03801876 · ClinicalTrials.gov registry record · Phase 3
Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer
A Phase 3 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage III Esophageal Adenocarcinoma AJCC v8, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT03801876: Recruiting Phase 3 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage III Esophageal Adenocarcinoma AJCC v8, sponsored by NRG Oncology.
NCT03801876 is a Phase 3 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage III Esophageal Adenocarcinoma AJCC v8 that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 300 participants, above the 82-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (266% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03801876, a Phase 3 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage III Esophageal Adenocarcinoma AJCC v8, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor without damaging much of the healthy tissue around it. Intensity modulated photon radiotherapy uses high-energy x-rays to deliver radiation directly to the tumor without damaging much of the healthy tissue around it. It is not yet known whether proton beam therapy or intensity modulated photon radiotherapy will work better in treating patients with esophageal cancer.
Primary Outcome
Will be estimated by the Kaplan-Meier method. The distributions of OS between treatment arms will be compared using the log rank test.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Docetaxel
- DRUG Capecitabine
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- UM Sylvester Comprehensive Cancer Center at Doral - Doral
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- Miami Cancer Institute - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- Orlando Health Cancer Institute - Orlando
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Illinois
- Alton Memorial Hospital - Alton
- Northwestern Medicine Cancer Center Kishwaukee - DeKalb
- Northwestern Medicine Cancer Center Delnor - Geneva
- Memorial Hospital East - Shiloh
- Northwestern Medicine Cancer Center Warrenville - Warrenville
Georgia
- Emory Proton Therapy Center - Atlanta
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2019-06-26 |
| Est. Completion | 2031-12-21 |
| Phase | Phase 3 |
What NCT03801876 shows while recruiting
NCT03801876 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 82-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (266% higher).
The record links to 10 conditions, with Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT03801876 names 20 study sites across 5 states, led by Florida, Illinois, Georgia.
Frequently Asked Questions
What is clinical trial NCT03801876 about?
NCT03801876 is a clinical study titled "Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer". This trial studies how well proton beam radiation therapy compared with intensity modulated photon radiotherapy works in treating patients with stage I-IVA esophageal cancer. Proton beam radiation therapy uses a beam of protons (rather than x-rays) to send radiation inside the body to the tumor with...
What is the current status of trial NCT03801876?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2019-06-26. Estimated completion is 2031-12-21.
What conditions does trial NCT03801876 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, Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8.
What interventions are being tested in trial NCT03801876?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Docetaxel (DRUG), Capecitabine (DRUG).
Who is sponsoring clinical trial NCT03801876?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03801876 being conducted?
This trial has 20 study locations across Arizona, Arkansas, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03801876's enrollment target sits among peer trials
300 2nd of 19 the highest of 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials
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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