# ESPAC-3

Source: https://onco.cc/trials/espac-3/  
OnCo record `espac-3` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

ESPAC-3 compared the two adjuvant chemotherapies then available after pancreatic cancer surgery and found they gave the same survival, about 23 months, but gemcitabine caused half as many serious side effects; a companion cohort in ampullary and bile duct cancers is still the main randomised evidence for adjuvant chemotherapy in those rarer tumours.

## Summary

ESPAC-3 was the European Study Group for Pancreatic Cancer's phase 3 trial at 159 centres in Europe, Australasia, Japan and Canada. After ESPAC-1 established adjuvant chemotherapy, the observation arm was removed and 1,088 patients with resected pancreatic ductal adenocarcinoma were randomised to six months of fluorouracil with folinic acid or gemcitabine. The primary endpoint was overall survival.

Median survival was 23.0 months with fluorouracil and 23.6 months with gemcitabine (hazard ratio 0.94), with no difference in progression-free survival or quality of life, but treatment-related serious adverse events were twice as common with fluorouracil (14 against 7.5 percent). A periampullary cohort of 428 patients randomised between observation and the two regimens showed a survival benefit for chemotherapy after adjustment for prognostic factors, which is why the corpus's ampullary cancer page cites ESPAC-3 as its adjuvant evidence.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-22
- Also known as: ESPAC-3 (v2); ESPAC3
- Tags: soc-trials
- Registry id: NCT00058201
- Phase: 3
- Setting: Resected pancreatic ductal adenocarcinoma (and a separate periampullary cohort): six months of adjuvant fluorouracil with folinic acid against gemcitabine, with overall survival as the primary endpoint; an observation arm was dropped when ESPAC-1 showed chemotherapy helped
- Sponsor: Royal Liverpool University Hospital
- Enrolled: 1088
- Result: Median overall survival 23.0 months with fluorouracil plus folinic acid against 23.6 months with gemcitabine (hazard ratio 0.94, p 0.39); treatment-related serious adverse events 14 against 7.5 percent.
- Outcomes: Overall survival, pancreatic ductal adenocarcinoma cohort: Adjuvant fluorouracil + folinic acid 23 months vs Adjuvant gemcitabine 23.6 months, HR 0.94; Patients with treatment-related serious adverse events: Adjuvant fluorouracil + folinic acid 14% vs Adjuvant gemcitabine 7.5%

## Sources

- ClinicalTrials.gov NCT00058201: https://clinicaltrials.gov/study/NCT00058201

## Connected records

- cancers: [Ampullary cancer (ampulla of Vater)](https://onco.cc/cancers/ampullary/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/), [Resectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/resectable-pdac/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/)
- drugs: [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/), [Leucovorin (folinic acid)](https://onco.cc/drugs/leucovorin/)
- key papers: [ESPAC-3: adjuvant fluorouracil plus folinic acid versus gemcitabine after pancreatic cancer resection](https://onco.cc/key-papers/paper-espac-3-fluorouracil-vs-gemcitabine-adjuvant-neoptolemos-jama-2010/)

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