# CONKO-007

Source: https://onco.cc/trials/conko-007/  
OnCo record `conko-007` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

CONKO-007 is the largest test of radiotherapy after chemotherapy for pancreatic cancer that cannot be removed at diagnosis: chemoradiotherapy did not raise the share of all patients reaching a clear-margin operation (25 against 18 percent) or lengthen survival, but among those operated the margins were clear more often (69 against 50 percent).

## Summary

CONKO-007 enrolled 525 patients with unresectable tumours; after three months of induction 336 were randomised to continue the same chemotherapy (167) or to chemoradiotherapy (169). Slow recruitment led the investigators to change the primary endpoint from overall survival to the overall R0 resection rate after an interim analysis; median follow-up was 76 months. R0 resection was achieved in 25 percent (43 of 169) after chemoradiotherapy against 18 percent (30 of 167) after chemotherapy (p 0.113), not significant; surgery was performed equally often and among operated patients the R0 rate was 69.4 against 50.0 percent (p 0.04), with the R0/R1/R2/no-resection distribution also favouring chemoradiotherapy (p 0.02). Overall survival did not differ (hazard ratio 0.937, 95 percent confidence interval 0.747 to 1.174; p 0.57) while surgery itself was associated with longer survival (hazard ratio 0.525). Letters in JCO 2026 debated the endpoint change and the gemcitabine radiosensitiser; the corpus reads it with LAP07 (no survival gain, better local control) and SCALOP (capecitabine as the preferred radiosensitiser).

## Fields

- Kind: Trial
- Status: mixed
- Last checked: 2026-09-24
- Also known as: CONKO 007
- Registry id: NCT01827553
- Phase: 3
- Setting: Unresectable locally advanced pancreatic cancer in Germany: three months of induction chemotherapy (FOLFIRINOX in 402, gemcitabine in 93), then randomisation of patients without progression to continued chemotherapy or chemoradiotherapy (50.4 Gy with gemcitabine), with resectability reassessed by a central surgical panel; the primary endpoint was changed from overall survival to the overall R0 resection rate
- Sponsor: University of Erlangen-Nuremberg (CONKO study group)
- Enrolled: 336
- Result: Overall R0 resection rate 25 percent with chemoradiotherapy against 18 percent with chemotherapy (p 0.113); R0 among operated patients 69.4 against 50.0 percent (p 0.04); overall survival hazard ratio 0.937 (p 0.57).
- Outcomes: R0 resection rate, all randomised patients: Induction chemotherapy then chemoradiotherapy 25% vs Continued chemotherapy 18%; Overall survival (randomised intention to treat): Induction chemotherapy then chemoradiotherapy vs Continued chemotherapy, HR 0.937

## Sources

- ClinicalTrials.gov NCT01827553: https://clinicaltrials.gov/study/NCT01827553
- Fietkau et al., CONKO-007 (JCO 2025): https://doi.org/10.1200/JCO-24-01502

## Connected records

- cancers: [Locally advanced unresectable pancreatic ductal adenocarcinoma](https://onco.cc/cancers/locally-advanced-pdac/), [Pancreatic ductal adenocarcinoma](https://onco.cc/cancers/pancreatic/)
- terms: [Chemoradiation (chemoradiotherapy, CRT)](https://onco.cc/terms/chemoradiation/), [Pancreatic cancer: the failed and stopped programmes and why](https://onco.cc/terms/pancreatic-failed-programmes/), [Resectable, borderline resectable and unresectable](https://onco.cc/terms/resectability/), [Resection margins (R0 / R1 / R2)](https://onco.cc/terms/resection-margins/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- drugs: [FOLFIRINOX / mFOLFIRINOX](https://onco.cc/drugs/folfirinox/), [Gemcitabine](https://onco.cc/drugs/gemcitabine/)
- trials: [LAP07](https://onco.cc/trials/lap07/), [PANOVA-3](https://onco.cc/trials/panova-3/)

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