# SAKK 16/00

Source: https://onco.cc/trials/sakk-16-00/  
OnCo record `sakk-16-00` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A Swiss trial asked whether lung cancer that has reached the lymph nodes in the middle of the chest does better with radiotherapy added to chemotherapy before the operation. It did not, which spared patients a treatment that adds side effects without adding benefit.

## Summary

SAKK 16/00 enrolled 232 patients with pathologically proven stage IIIA/N2 non-small-cell lung cancer at 23 centres in Switzerland, Germany and Serbia between 2001 and 2012. Everyone received three cycles of cisplatin 100 mg/m2 and docetaxel 85 mg/m2; 117 were randomised to radiotherapy of 44 Gy in 22 fractions over three weeks before surgery and 115 to surgery after chemotherapy alone. Median event-free survival, the primary endpoint, was 12.8 months with radiotherapy and 11.6 months without (p=0.67); median overall survival was 37.1 and 26.2 months, with wide confidence intervals. Grade 3 dysphagia from radiotherapy occurred in 7 per cent. The authors concluded that one definitive local treatment combined with induction chemotherapy is adequate. It was funded by the Swiss State Secretariat for Education, Research and Innovation, the Swiss Cancer League and Sanofi.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-11-03
- Also known as: SAKK 16/00 induction chemoradiation trial; Preoperative chemoradiotherapy vs chemotherapy alone in stage IIIA/N2 NSCLC
- Registry id: NCT00030771
- Phase: 3
- Setting: Resectable stage IIIA/N2 non-small-cell lung cancer: three cycles of cisplatin and docetaxel before surgery, with or without 44 Gy of radiotherapy in 22 fractions
- Sponsor: Swiss Cancer Institute (formerly SAKK)
- Enrolled: 232
- Result: Adding radiotherapy to induction chemotherapy before surgery did not improve event-free survival: median 12.8 against 11.6 months (p=0.67).
- Outcomes: Event-free survival: Chemotherapy then radiotherapy then surgery 12.8 months vs Chemotherapy then surgery 11.6 months; Overall survival: Chemotherapy then radiotherapy then surgery 37.1 months vs Chemotherapy then surgery 26.2 months

## Sources

- ClinicalTrials.gov NCT00030771: https://clinicaltrials.gov/study/NCT00030771
- Lancet 2015: https://doi.org/10.1016/S0140-6736(15)60294-X
- PubMed: https://pubmed.ncbi.nlm.nih.gov/26275735/

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- fronts: [Chemotherapy](https://onco.cc/fronts/chemotherapy/), [Radiation Therapy](https://onco.cc/fronts/radiation/)
- companies: [Swiss Cancer Institute (formerly SAKK)](https://onco.cc/companies/swiss-cancer-institute/)
- institutions: [Swiss Cancer League (Krebsliga Schweiz)](https://onco.cc/institutions/swiss-cancer-league/)
- bottlenecks: [Surgery and radiotherapy cure most, get least](https://onco.cc/bottlenecks/b-surgery-radiation-innovation/)
- key papers: [Induction chemoradiation in stage IIIA/N2 non-small-cell lung cancer: a phase 3 randomised trial (SAKK 16/00)](https://onco.cc/key-papers/paper-pless-sakk-16-00-induction-chemoradiation-lancet-2015/)

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