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NCT04559139 · ClinicalTrials.gov registry record · Phase 2
Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder Cancer
A Phase 2 study of Stage III Gallbladder Cancer AJCC v8 and Stage II Gallbladder Cancer AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 2
- Development phase
- 186
- Enrollment target
- 20
- Study locations
NCT04559139: Active Phase 2 study of Stage III Gallbladder Cancer AJCC v8 and Stage II Gallbladder Cancer AJCC v8, sponsored by ECOG-ACRIN Cancer Research Group.
NCT04559139 is a Phase 2 study of Stage III Gallbladder Cancer AJCC v8 and Stage II Gallbladder Cancer AJCC v8 that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 186 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04559139, a Phase 2 study of Stage III Gallbladder Cancer AJCC v8 and Stage II Gallbladder Cancer AJCC v8, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 186 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II/III trial compares the effect of adding chemotherapy before and after surgery versus after surgery alone (usual treatment) in treating patients with stage II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine and cisplatin, 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. Giving chemotherapy before surgery may make the tumor smaller; therefore, may reduce the extent of surgery. Additionally, it may make it easier for the surgeon to distinguish between normal and cancerous tissue. Giving chemotherapy after surgery may kill any remaining tumor cells. This study will determine whether giving chemotherapy before surgery increases the length of time before the cancer may return and whether it will increase a patient's life span compared to the usual approach.
Primary Outcome
Will compare patients with incidental gallbladder cancer (IGBC) who receive perioperative chemotherapy prior to and after re-resection with patients who receive only adjuvant chemotherapy after re-resection. Will be evaluated by stratified log rank test, and Kaplan-Meier analyses will be used to calculate and display the overall survival distributions among all randomized patients on the two study arms (intention-to-treat analysis).
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine Hydrochloride
- PROCEDURE Lymphadenectomy
- PROCEDURE Partial Hepatectomy
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
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- CARTI Cancer Center - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
California
- Mission Hope Medical Oncology - Arroyo Grande - 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
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Arizona
- Cancer Center at Saint Joseph's - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2021-02-24 |
| Est. Completion | 2029-06-30 |
| Phase | Phase 2 |
What the registry record for NCT04559139 still lists
NCT04559139 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% higher).
The record links to 6 conditions, with Stage III Gallbladder Cancer AJCC v8 appearing as the primary indexed condition, and to 4 interventions - of which Cisplatin is the first listed.
NCT04559139 names 20 study sites across 5 states, led by Alaska, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT04559139 about?
NCT04559139 is a clinical study titled "Comparison of Chemotherapy Before and After Surgery Versus After Surgery Alone for the Treatment of Gallbladder Cancer". This phase II/III trial compares the effect of adding chemotherapy before and after surgery versus after surgery alone (usual treatment) in treating patients with stage II-III gallbladder cancer. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumo...
What is the current status of trial NCT04559139?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 186 participants. The study started on 2021-02-24. Estimated completion is 2029-06-30.
What conditions does trial NCT04559139 study?
This clinical trial studies the following conditions: Stage III Gallbladder Cancer AJCC v8, Stage II Gallbladder Cancer AJCC v8, Stage IIA Gallbladder Cancer AJCC v8, Stage IIB Gallbladder Cancer AJCC v8, Stage IIIA Gallbladder Cancer AJCC v8.
What interventions are being tested in trial NCT04559139?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine Hydrochloride (DRUG), Lymphadenectomy (PROCEDURE), Partial Hepatectomy (PROCEDURE).
Who is sponsoring clinical trial NCT04559139?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04559139 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04559139's enrollment target sits among peer trials
186 357th of 2000 higher than 1,644 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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