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

Journal of Surgical Oncology

Volumn 101, Issue 7, 2010, Pages 587-592

  Landry, Jerome ^a   Catalano, Paul J ^b   Staley, Charles ^a   Harris, Wayne ^a   Hoffman, John ^c   Talamonti, Mark ^d   Xu, Natalie ^a   Cooper, Harry ^c   Bensoniii, Al B ^d  

^a EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b HARVARD UNIVERSITY   (United States)

^c FOX CHASE CANCER CENTER   (United States)

^d NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Gemcitabine; Pancreatic cancer; Radiotherapy

Indexed keywords

CISPLATIN; FLUOROURACIL; GEMCITABINE;

ADULT; ADVANCED CANCER; ARTICLE; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG SAFETY; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; MALE; MONOTHERAPY; MULTICENTER STUDY; MULTIMODALITY CANCER THERAPY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; PANCREAS ADENOCARCINOMA; PHASE 2 CLINICAL TRIAL; PREOPERATIVE TREATMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTOPENIA; TREATMENT RESPONSE; VOMITING;

ADENOCARCINOMA; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; DEOXYCYTIDINE; FEMALE; FLUOROURACIL; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOADJUVANT THERAPY; PANCREATIC NEOPLASMS; RADIOTHERAPY; SAFETY; SURVIVAL ANALYSIS;

EID: 77952028206     PISSN: 00224790     EISSN: 10969098     Source Type: Journal    
DOI: 10.1002/jso.21527     Document Type: Article

References (20)

1. Lawrence TS, Eisbruch A, Shewach DS: Gemcitabine-mediated radiosensitization. Semin Oncol 1997;24:S7-24-S7-28.
2. Burris HA III, Moore MJ, Anderson J, et al.: Phase I and pharmacologic study of oral topotecan administered twice daily for 21 days to adult patients with solid tumors. J Clin Oncol 1997;15:1087-1093.
3. Rothenberg ML, Benedetti JK, Macdonald JS, et al.: Phase II trial of 5-fluorouracil plus eniluracil in patients with advanced pancreatic cancer: A Southwest Oncology Group study. Ann Oncol 2002;13:1576-1582.
4. Moossa AR, Lewis MH, Mackie CR: Surgical treatment of pancreatic cancer. Mayo Clinic Proc 1979;54:468-474.
5. McGinn CJ, Zalupski MM, Shureiqui I, et al.: Phase I trial of radiation dose escalation with concurrent weekly full-dose gemcitabine in patients with advanced pancreatic cancer. J Clin Oncol 2001;19:4202-4208.
6. Hoffman JP, McGinn CJ, Ross E, et al.: A phase I trial of preoperative gemcitabine and radiotherapy followed by postoperative gemcitabine for patients with localized, resectable pancreatic adenocarcinoma. Cancer Invest 1999;17:30-32.
7. Wolff RA, Evans DB, Gravel DM, et al.: Phase I trial of gemcitabine combined with radiation for the treatment of locally advanced pancreatic adenocarcinoma. Clin Cancer Res 2001;7:2246-2253.
8. Murphy JD, Adusumili S, Griffith KA, et al.: Full-dose gemcitabine and concurrent radiotherapy for unresectable pancreatic cancer. Int J Radiat Oncol Biol Phys 2007;68:801-808 [Epub 2007 March 26].
9. Talamonti MS, Small W, Jr., Mulcahy MF, et al.: A multi-institutional phase II trial of preoperative full-dose gemcitabine and concurrent radiation for patients with potentially resectable pancreatic carcinoma. Ann Surg Oncol 2006;13:150-158 [Epub 2006 January 19].
10. Blackstock AW, Bernard SA, Richards F, et al.: Phase I trial of twice-weekly gemcitabine and concurrent radiation in patients with advanced pancreatic cancer. J Clin Oncol 1999;17:2208-2212.
11. Joensuu TK, Kiviluoto T, Karkkainen P, et al.: Phase I-II trial of twice-weekly gemcitabine and concomitant irradiation in patients undergoing pancreaticoduodenectomy with extended lymphadenectomy for locally advanced pancreatic cancer. Int J Radiat Oncol Biol Phys 2004;60:444-452.
12. Epelbaum R, Rosenblatt E, Nasrallah S, et al.: Phase II study of gemcitabine combined with radiation therapy in patients with localized, unresectable pancreatic cancer. J Surg Oncol 2002;81:138-143.
13. Therasse P, Arbuck SG, Eisenhauer EA, et al.: RECIST: New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000;92:205-216.
14. Kalser MH, Ellenberg SS: Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg 1985;120:899-903.
15. Klinkenbijl HH, Jeekel J, Sahmoud T, et al.: Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: Phase III trial of the EORTC Gastrointestinal Tract Cancer Cooperative Group. Ann Surg 1999;230:776-784.
16. Regine WF, Winter KW, Abrams R, et al.: RTOG 9704 a phase III study of adjuvant pre- and post-chemoradiation (CRT) 5-FU vs. gemcitibine (G) for resected pancreatic adenocarcinoma. J Clin Oncol (ASCO Annual Meeting, Part I) 2006;24: (abstract 14056).
17. Staley CA, Harris WB, Landry J, et al.: Neoadjuvant induction chemotherapy followed by chemoradiation: A phase I trial of gemcitabine, cisplatin, and 5-fluorouracil for advanced pancreatic/gastrointestinal malignancies. Surg Oncol Clin N Am 2004;13:697-709.
18. Staley CA, Lee JE, Cleary KR, et al.: Preoperative chemoradiation, pancreaticoduodenectomy, and intraoperative radiation therapy for adenocarcinoma of the pancreatic head. Am J Surg 1996;171:118-124, discussion 124-125.
19. Tempero M, PlunkettW, Ruiz Van Haperen V, et al.: Randomized phase II comparison of dose-intense gemcitabine: Thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma. J Clin Oncol 2003;21:3402-3408 [Epub 2003 July 28].
20. Ammori JB, Colletti LM, Zalupski MM, et al.: Surgical resection following radiation therapy with concurrent gemcitabine in patients with previously unresectable adenocarcinoma of the pancreas. J Gastrointest Surg 2003;7:766-772.