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NCT04248452 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal and Gastric Cancer That Has Spread to a Limited Number of Other Places in the Body
A Phase 3 study of Clinical Stage IV Gastric Cancer AJCC v8 and Clinical Stage IVA Gastric Cancer AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 3
- Development phase
- 314
- Enrollment target
- 20
- Study locations
NCT04248452 is a Phase 3 study of Clinical Stage IV Gastric Cancer AJCC v8 and Clinical Stage IVA Gastric Cancer AJCC v8 that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 314 participants, above the 205-participant average among 17 other Clinical Stage IV Gastric Cancer AJCC v8 trials with a reported enrollment target (53% higher). The trial reports 20 study locations across 4 states.
The verdict
NCT04248452, a Phase 3 study of Clinical Stage IV Gastric Cancer AJCC v8 and Clinical Stage IVA Gastric Cancer AJCC v8, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 314 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies how well the addition of radiotherapy to the usual treatment (chemotherapy) works compared to the usual treatment alone in treating patients with esophageal and gastric cancer that has spread to a limited number of other places in the body (oligometastatic disease). Radiotherapy uses high energy x-rays, gamma rays, or protons to kill tumor cells and shrink tumors. Drugs used in usual chemotherapy, such as leucovorin, 5-fluorouracil, oxaliplatin, and capecitabine, 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. Adding radiotherapy to the usual chemotherapy may work better compared to the usual chemotherapy alone in treating patients with esophageal and gastric cancer.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Leucovorin Calcium
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Mercy Cancer Center - Elk Grove - Elk Grove
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- Mercy Cancer Center - Merced
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CARTI Cancer Center - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2020-05-26 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04248452
The ClinicalTrials.gov registry entry for NCT04248452 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 205-participant average among 17 other Clinical Stage IV Gastric Cancer AJCC v8 trials with a reported enrollment target (53% higher). The listed sponsor is ECOG-ACRIN Cancer Research Group, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Clinical Stage IV Gastric Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT04248452 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Alaska, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT04248452 about?
NCT04248452 is a clinical study titled "Testing the Addition of Radiotherapy to the Usual Treatment (Chemotherapy) for Patients With Esophageal and Gastric Cancer That Has Spread to a Limited Number of Other Places in the Body". This phase III trial studies how well the addition of radiotherapy to the usual treatment (chemotherapy) works compared to the usual treatment alone in treating patients with esophageal and gastric cancer that has spread to a limited number of other places in the body (oligometastatic disease). Radi...
What is the current status of trial NCT04248452?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 314 participants. The study started on 2020-05-26. Estimated completion is 2028-03-31.
What conditions does trial NCT04248452 study?
This clinical trial studies the following conditions: Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVB Gastric Cancer AJCC v8, Metastatic Gastric Adenocarcinoma.
What interventions are being tested in trial NCT04248452?
The interventions under investigation include: Capecitabine (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Leucovorin Calcium (DRUG).
Who is sponsoring clinical trial NCT04248452?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04248452 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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