Adjuvant chemotherapy with gemcitabine versus observation in patients undergoing curative-intent resection of pancreatic cancer: a multicentre randomised controlled trial

Conditions

Pancreatic cancer Cancer Malignant neoplasm of pancreas

Sinn M, Riess H, Sinn BV, Stieler JM, Pelzer U, Striefler JK, Oettle H, Bahra M, Denkert C, Bläker H, Lohneis P.

2015-06-0331 citations

10.1016/j.ejca.2015.05.005

Adjuvant Chemotherapy With Gemcitabine and Long-term Outcomes Among Patients With Resected Pancreatic Cancer

Helmut Oettle, P. Neuhaus, Andreas Hochhaus, Jörg T. Hartmann, Klaus Gellert et al. (13 authors)

JAMA2013-10-081,772 citations

10.1001/jama.2013.279201

Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial.

Oettle H, Post S, Neuhaus P, Gellert K, Langrehr J, Ridwelski K, Schramm H, Fahlke J, Zuelke C, Burkart C, Gutberlet K, Kettner E, Schmalenberg H, Weigang-Koehler K, Bechstein WO, Niedergethmann M, Schmidt-Wolf I, Roll L, Doerken B, Riess H.

2007-01-011,675 citations

10.1001/jama.297.3.267

Interventions

Patients were randomised, with stratification for resection, T and nodal status, to receive adjuvant chemotherapy with six cycles of gemcitabine day one, eight and 15 every four weeks (Arm A) or obser

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven resected pancreatic carcinoma 2. Standard operation 3. No measurable disease 4. No prior chemo- or radiotherapy 5. No active infection 6. Karnofsky performance status minimum 50% 7. Adequate haematologic, renal and hepatic function 8. Cancer antigen 19-9 (CA 19-9), carcinoembryonic antigen (CEA) less than 2.5 x upper limit of normal (ULN) 9. Start with adjuvant therapy within six weeks after resection 10. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Active infection 2. Impaired coagulation (international normalised ratio [INR] and/or activated partial thromboplastin time [aPPT] more than 1.5 x ULN) 3. Transaminases more than 3 x ULN 4. Serum creatinine more than 1.5 x ULN 5. Postoperative tumour markers (CEA/CA19-9) more than 2.5 x ULN 6. History of another malignant disease other than carcinoma in situ of the uterine cervix or adequately treated basal cell carcinoma of the skin 7. Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
Disease-free survival (DFS)	—

Secondary

Measure	Time frame
1. Overall survival (OS) 2. Toxicity 3. Quality of life	—

Countries

Austria, Germany

Outcome results

None listed