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Clinical Trial
. 2010 Jun 1;101(7):587-92.
doi: 10.1002/jso.21527.

Randomized phase II study of gemcitabine plus radiotherapy versus gemcitabine, 5-fluorouracil, and cisplatin followed by radiotherapy and 5-fluorouracil for patients with locally advanced, potentially resectable pancreatic adenocarcinoma

Jerome Landry  1 , Paul J Catalano, Charles Staley, Wayne Harris, John Hoffman, Mark Talamonti, Natalie Xu, Harry Cooper, Al B Benson 3rd
Affiliations
Clinical Trial

Randomized phase II study of gemcitabine plus radiotherapy versus gemcitabine, 5-fluorouracil, and cisplatin followed by radiotherapy and 5-fluorouracil for patients with locally advanced, potentially resectable pancreatic adenocarcinoma

Jerome Landry et al. J Surg Oncol. .

Abstract

Purpose: A randomized phase II trial (E1200) was designed to assess toxicities and surgical resection rates in two neoadjuvant gemcitabine-based chemoradiation regimens in patients with borderline resectable pancreatic cancer. The trial was terminated early due to poor accrual.

Patients and methods: Patients with borderline resectable adenocarcinomas of the pancreas were enrolled. Arm A patients (n = 10) received gemcitabine 500 mg/m(2) IV weekly for 6 weeks, with radiation to 50.4 Gy followed by surgical resection. Arm B patients (n = 11) received preoperative gemcitabine 175 mg/m(2) on days 1, 5, 29, and 33, cisplatin 20 mg/m(2) on days 1-5 and 29-32, 5-FU 600 mg/m(2) on days 1-5 and 29-32, followed by radiation with continuous infusion 5-FU 225 mg/m(2) for 6 weeks. All patients received adjuvant gemcitabine 1,000 mg/m(2) weekly x 3 for five cycles.

Results: Three patients in arm A, and two patients in arm B were resected. Hematologic toxicity was comparable between the two arms except more patients in arm B developed grade 3 or 4 thrombocytopenia than those in arm A. Arm B had fewer grade 1-2 GI toxicities although more patients (45%) experienced grade 3-4 GI toxicity.

Conclusions: This phase II trial showed that both regimens were tolerable, and resectability and survival were comparable to previous studies.

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Figures

Figure 1
Figure 1. ECOG 1200 Schema 226×163mm (96 × 96 DPI)
Figure 2
Figure 2. Overall survival by arm for patients with pancreatic adenocarcinoma 215×279mm (300 × 300 DPI)
Figure 3
Figure 3. Progression-free survival for patients with pancreatic adenocarcinoma 215×279mm (300 × 300 DPI)
See this image and copyright information in PMC

References

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