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*, Paul J. Catalano, Charles Staley, Wayne Harris, John Hoffman, Mark Talamonti, Natalie Xu, Harry Cooper, Al B Benson III

*Corresponding author for this work

Research output: Contribution to journalArticle

103 Citations (Scopus)

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/m2 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/m2 on days 1, 5, 29, and 33, cisplatin 20 mg/m2 on days 1-5 and 29-32, 5-FU 600 mg/m2 on days 1-5 and 29-32, followed by radiation with continuous infusion 5-FU 225 mg/m2 for 6 weeks. All patients received adjuvant gemcitabine 1,000 mg/m2 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.

Original languageEnglish (US)
Pages (from-to)587-592
Number of pages6
JournalJournal of Surgical Oncology
Volume101
Issue number7
DOIs
StatePublished - Jun 1 2010

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gemcitabine
Fluorouracil
Cisplatin
Adenocarcinoma
Radiotherapy
Radiation

Keywords

  • Gemcitabine
  • Pancreatic cancer
  • Radiotherapy

ASJC Scopus subject areas

  • Surgery
  • Oncology

Cite this

@article{bcdf31d5c73e43ada9d108fbcb27f4f3,
title = "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",
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/m2 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/m2 on days 1, 5, 29, and 33, cisplatin 20 mg/m2 on days 1-5 and 29-32, 5-FU 600 mg/m2 on days 1-5 and 29-32, followed by radiation with continuous infusion 5-FU 225 mg/m2 for 6 weeks. All patients received adjuvant gemcitabine 1,000 mg/m2 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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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. / Landry, Jerome; Catalano, Paul J.; Staley, Charles; Harris, Wayne; Hoffman, John; Talamonti, Mark; Xu, Natalie; Cooper, Harry; Benson III, Al B.

In: Journal of Surgical Oncology, Vol. 101, No. 7, 01.06.2010, p. 587-592.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

AU - Landry, Jerome

AU - Catalano, Paul J.

AU - Staley, Charles

AU - Harris, Wayne

AU - Hoffman, John

AU - Talamonti, Mark

AU - Xu, Natalie

AU - Cooper, Harry

AU - Benson III, Al B

PY - 2010/6/1

Y1 - 2010/6/1

N2 - 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/m2 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/m2 on days 1, 5, 29, and 33, cisplatin 20 mg/m2 on days 1-5 and 29-32, 5-FU 600 mg/m2 on days 1-5 and 29-32, followed by radiation with continuous infusion 5-FU 225 mg/m2 for 6 weeks. All patients received adjuvant gemcitabine 1,000 mg/m2 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.

AB - 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/m2 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/m2 on days 1, 5, 29, and 33, cisplatin 20 mg/m2 on days 1-5 and 29-32, 5-FU 600 mg/m2 on days 1-5 and 29-32, followed by radiation with continuous infusion 5-FU 225 mg/m2 for 6 weeks. All patients received adjuvant gemcitabine 1,000 mg/m2 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.

KW - Gemcitabine

KW - Pancreatic cancer

KW - Radiotherapy

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