Preliminary Results: A randomised, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine vs. observation in patients with resected pancreatic cancer - CONKO*-001- P. Neuhaus, H. Oettle, S. Post, K. Gellert, K. Ridwelski, H. Schramm, C. Zülke, G. Fahlke, J. Langrehr, L. Roll, H. Riess Charitè - Universitätsmedizin Berlin - Campus Virchow Klinikum; Ruprecht-Karls-Universität, Mannheim; Oskar-Ziethen- Krankenhaus, Berlin; Otto-von-Guericke-Universität, Magdeburg; Wald-Klinikum, Gera; Universität Regensburg, Regensburg; AIO; CAO; Deutsche *CHARITÉ ONKOLOGIE:Clinical studies in GI cancers
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*C HARITÉ ONKO LOGIE:Clinical studies in GI cancers
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Preliminary Results:
A randomised, prospective, multicenter phase III trial of adjuvant chemotherapy with gemcitabine vs.
observation in patients with resected pancreatic cancer
- CONKO*-001-
P. Neuhaus, H. Oettle, S. Post, K. Gellert, K. Ridwelski, H. Schramm,
C. Zülke, G. Fahlke, J. Langrehr, L. Roll, H. RiessCharitè - Universitätsmedizin Berlin - Campus Virchow Klinikum;
Universität Regensburg, Regensburg; AIO; CAO; Deutsche Krebsgesellschaft e.V.
*CHARITÉ ONKOLOGIE:Clinical studies in GI cancers
Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum
CONKO-001 Rationale
Prognosis in disease free survival with pancreatic cancer is still poor
Median survival after resection is 11 - 25 months
Long term survival (>5 years) is 8 - 21percent
Bakkevold (1993); Klinkenbijl (1999); Gastrointestinal Study Group (1985, 1987); Neoptolemos (2004)
Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum
CONKO-001 Study Design
Resected pancreatic cancer368 patients
Stratification: R; T; N
Follow up every 8 weeks
Gemcitabinefor 6 months
Observationfor 6 months
Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum
CONKO-001 Disease Monitoring
Gem
Obs
Gemcitabine 1000 mg/m²: d1, 8, 15; q 4 weeks
Observation: d1; q 4 weeks
Randomisati
on
Follow up every 8weeks
Gem
Ultrasoundafter week 8
Ultrasoundafter week 16
CT Scanafter week 32
Obs
Gem
Obs
Gem
Obs
Gem
Obs
Gem
Obs
Gem
Obs
CA 19-9 CA 19-9 CA 19-9 CA 19-9 CA 19-9 CA 19-9
4 weeks 4 weeks 4 weeks 4 weeks 4 weeks 4 weeks
CA 19-9
Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum
CONKO-001 Endpoints
Primary Endpoint Disease free survival (DFS)
Secondary Endpoint Overall survival (OS) Toxicity
Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum
CONKO-001 Entry Criteria
Histologically proven resected pancreatic carcinoma Standard operation No measurable disease No prior chemo- or radiotherapy No active infection Karnofsky performance status 50% Adequate hematologic, renal and hepatic function CA 19-9, CEA < 2.5 ULN Start with adjuvant therapy within 6 weeks after resection Written informed consent
Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum
CONKO-001 Statistics
Hypothesis: Significant increase in disease free survival (DFS) of
at least 6 months due to chemotherapy with gemcitabine
Statistics: Kaplan-Meier estimates und two-tailed log-rank test
with significance level of 0.05 and a power of 90%
Sample size: 368 pts – 184 pts per treatment arm (1:1 ratio) including an estimated drop out rate of up to 20%
Charité - Universitätsmedizin Berlin - Campus Virchow Klinikum