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NCT04523818 · ClinicalTrials.gov registry record · Phase 1
Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma
A Phase 1 study of Gastric Adenocarcinoma and Clinical Stage III Gastric Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04523818: Active Phase 1 study of Gastric Adenocarcinoma and Clinical Stage III Gastric Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT04523818 is a Phase 1 study of Gastric Adenocarcinoma and Clinical Stage III Gastric Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 25 participants, below the 245-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04523818, a Phase 1 study of Gastric Adenocarcinoma and Clinical Stage III Gastric Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib trial investigates the side effects and how well a shorter course of chemotherapy and radiation treatment (chemoradiotherapy) for 2 weeks instead of 5 weeks followed by standard chemotherapy works in treating patients with gastric cancer who are scheduled to have treatment and then surgery to remove the tumor. Chemotherapy drugs, such as capecitabine and fluorouracil, 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 sources to kill tumor cells and shrink tumors. Giving short-course chemo-radiotherapy before chemotherapy and surgery may help to control the disease.
Primary Outcome
Characterized by the incidence and severity of treatment-related adverse events. Grade 3 or higher toxicity classified as attributable to chemotherapy and radiation treatment (CXRT), during the 14 days of treatment administration or within 14 days of completion of CXRT (i.e., a total of 28 days), based on multidisciplinary review, will be used for the purpose of toxicity monitoring. Differences between grades vary and are detailed according to the Common Terminology Criteria for Adverse Events (
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Fluorouracil
- RADIATION Radiation Therapy
- PROCEDURE Therapeutic Surgical Procedure
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-08-11 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04523818 still lists
NCT04523818 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 245-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (90% lower).
The record links to 10 conditions, with Gastric Adenocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Capecitabine is the first listed.
NCT04523818 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04523818 about?
NCT04523818 is a clinical study titled "Short-Course Chemoradiotherapy Followed by Chemotherapy for the Treatment of Resectable Gastric Adenocarcinoma". This phase Ib trial investigates the side effects and how well a shorter course of chemotherapy and radiation treatment (chemoradiotherapy) for 2 weeks instead of 5 weeks followed by standard chemotherapy works in treating patients with gastric cancer who are scheduled to have treatment and then sur...
What is the current status of trial NCT04523818?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2020-08-11. Estimated completion is 2028-12-31.
What conditions does trial NCT04523818 study?
This clinical trial studies the following conditions: Gastric Adenocarcinoma, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage IVA Gastric Cancer AJCC v8, Clinical Stage I Gastric Cancer AJCC v8, Clinical Stage IIA Gastric Cancer AJCC v8.
What interventions are being tested in trial NCT04523818?
The interventions under investigation include: Capecitabine (DRUG), Fluorouracil (DRUG), Radiation Therapy (RADIATION), Therapeutic Surgical Procedure (PROCEDURE).
Who is sponsoring clinical trial NCT04523818?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04523818 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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