Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer
NCT04340141 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 358
Last updated 2026-02-10
Summary
This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, 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 and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).
Conditions
- Pancreatic Adenosquamous Carcinoma
- Resectable Pancreatic Adenocarcinoma
- Pancreatic Cancer
Interventions
- DRUG
-
Given IV
- DRUG
-
Irinotecan Hydrochloride
Given IV
- DRUG
-
Leucovorin Calcium
Given IV
- DRUG
-
Given IV
- PROCEDURE
-
Resection
Undergo surgical resection
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Alliance for Clinical Trials in Oncology
lead OTHER
Principal Investigators
-
Cristina R. Ferrone, MD · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-13
- Primary Completion
- 2028-12-31
- Completion
- 2030-11-01
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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