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

In Journal of the American Medical Associantion
By: Oettle H.
Contributor(s): Langrehr J | Gellert K | Neuhaus P | Post S | .
Material type: materialTypeLabelArticleSeries: Vol 297 Issues 3.Publisher: 2007Description: 267.Subject(s): Pancreatic Cancer | Gemcitabine | Chemotherapy | Adjuvant chemotherapy | DDC classification: In: Journal of the American Medical AssociantionSummary: Context The role of adjuvant therapy in resectable pancreatic cancer is still uncertain, and no recommended standard exists. Objective To test the hypothesis that adjuvant chemotherapy with gemcitabine administered after complete resection of pancreatic cancer improves disease-free survival by 6 months or more. Design, Setting, and Patients Open, multicenter, randomized controlled phase 3 trial with stratification for resection, tumor, and node status. Conducted from July 1998 to December 2004 in the outpatient setting at 88 academic and community-based oncology centers in Germany and Austria. A total of 368 patients with gross complete (R0 or R1) resection of pancreatic cancer and no prior radiation or chemotherapy were enrolled into 2 groups. Intervention Patients received adjuvant chemotherapy with 6 cycles of gemcitabine on days 1, 8, and 15 every 4 weeks (n = 179), or observation ([control] n = 175). Main Outcome Measures Primary end point was disease-free survival, and secondary e
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Articles Articles Tata Memorial Hospital
(Browse shelf) Available AR6559

Context The role of adjuvant therapy in resectable pancreatic cancer is still uncertain, and no recommended standard exists.

Objective To test the hypothesis that adjuvant chemotherapy with gemcitabine administered after complete resection of pancreatic cancer improves disease-free survival by 6 months or more.

Design, Setting, and Patients Open, multicenter, randomized controlled phase 3 trial with stratification for resection, tumor, and node status. Conducted from July 1998 to December 2004 in the outpatient setting at 88 academic and community-based oncology centers in Germany and Austria. A total of 368 patients with gross complete (R0 or R1) resection of pancreatic cancer and no prior radiation or chemotherapy were enrolled into 2 groups.

Intervention Patients received adjuvant chemotherapy with 6 cycles of gemcitabine on days 1, 8, and 15 every 4 weeks (n = 179), or observation ([control] n = 175).

Main Outcome Measures Primary end point was disease-free survival, and secondary e

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