ESPAC-5
ESPAC-5 randomised people whose pancreatic cancer sat on the border of being removable between going straight to surgery and having two months of chemotherapy or chemoradiotherapy first; those treated first were far more likely to be alive a year later, 78 to 84 percent with chemotherapy against 39 percent with immediate surgery, which supports treating before operating in borderline disease.
Overview
ESPAC-5 was a four-arm randomised phase 2 feasibility trial of the European Study Group for Pancreatic Cancer at 16 sites, randomising 90 patients with borderline resectable pancreatic cancer to immediate surgery (33), or two months of neoadjuvant gemcitabine plus capecitabine (20), FOLFIRINOX (20) or capecitabine-based chemoradiotherapy (17), each followed by surgery and adjuvant chemotherapy. The primary endpoints were recruitment rate and resection rate.
Resection rates were similar (68 percent after immediate surgery, 55 percent after neoadjuvant therapy) and R0 rates low in both (14 and 23 percent), but one-year overall survival was 39 percent with immediate surgery against 78 percent with gemcitabine plus capecitabine, 84 percent with FOLFIRINOX and 60 percent with chemoradiotherapy, and one-year disease-free survival from surgery was 33 against 59 percent (hazard ratio 0.53). The corpus's borderline resectable pancreatic cancer page cites ESPAC-5 with PREOPANC for neoadjuvant treatment and restaging before surgery.
- 68 vs 55 out of 100 reached this endpoint with Immediate surgery compared with Neoadjuvant therapy arms combined; 13 more per 100.
- Roughly one extra person helped for every 8 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.33) means the difference could plausibly be due to chance.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- 39 vs 78 out of 100 alive at 1 year with Immediate surgery compared with Neoadjuvant gemcitabine + capecitabine; 39 fewer per 100.
- On this measure the first group did worse, not better.
- Other groups: Neoadjuvant FOLFIRINOX 84 of 100; Neoadjuvant capecitabine-based chemoradiotherapy 60 of 100.
- The p-value (0.0028) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- 33 vs 59 out of 100 alive without the cancer coming back at 1 year with Immediate surgery compared with Neoadjuvant therapy arms combined; 26 fewer per 100.
- On this measure the first group did worse, not better.
- Put another way, the treated group had about 47 percent lower chance of the event at any given time (hazard ratio 0.53, likely range 0.28 to 0.98).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- 14 vs 23 out of 100 reached this endpoint with Immediate surgery compared with Neoadjuvant therapy arms combined; 9 fewer per 100.
- On this measure the first group did worse, not better.
- The p-value (0.49) means the difference could plausibly be due to chance.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Borderline resectable pancreatic cancer in the United Kingdom and Germany: immediate surgery against short-course neoadjuvant gemcitabine plus capecitabine, FOLFIRINOX or capecitabine-based chemoradiotherapy, each followed by surgery and adjuvant chemotherapy, with recruitment and resection rate as the primary endpoints of a four-arm feasibility trial. People in a different situation may not see the same effect.
- Only 90 people took part, so the numbers are less certain than in a large trial.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
90 randomised.
21 of 31 · 30 of 55
Source95% CI 24 to 61 · 95% CI 60 to 100 · 95% CI 70 to 100 · 95% CI 37 to 97
Source95% CI 19 to 58 · 95% CI 46 to 74
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Resection rateprimary | Immediate surgery | 31 | 68% | - | 0.33 | link |
| Neoadjuvant therapy arms combined | 55 | 55% | ||||
| Overall survival at 1 year | Immediate surgery | 31 | 39% | - | 0.0028 | link |
| Neoadjuvant gemcitabine + capecitabine | 19 | 78% | ||||
| Neoadjuvant FOLFIRINOX | 20 | 84% | ||||
| Neoadjuvant capecitabine-based chemoradiotherapy | 16 | 60% | ||||
| Disease-free survival at 1 year from surgery | Immediate surgery | - | 33% | 0.53 (0.28 to 0.98) | 0.016 | link |
| Neoadjuvant therapy arms combined | - | 59% | ||||
| R0 resection among resected patients | Immediate surgery | 21 | 14% | - | 0.49 | link |
| Neoadjuvant therapy arms combined | 30 | 23% |
Similar pages
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