Phase I/II trial of hyperfractionated accelerated chemoradiotherapy for unresectable advanced pancreatic cancer

Japanese Journal of Clinical Oncology

Volumn 36, Issue 8, 2006, Pages 504-510

  Tsujie, Masanori ^a   Nakamori, Shoji ^a,b   Tanaka, Eiichi ^a,c   Nagano, Hiroaki ^a   Umeshita, Koji ^a   Dono, Keizo ^a   Sakon, Masato ^a   Inoue, Takehiro ^a   Inoue, Toshihiko ^a   Monden, Morito ^a  

^a OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b OSAKA NATIONAL HOSPITAL   (Japan)

^c OSAKA MEDICAL CENTER FOR CANCER AND CARDIOVASCULAR DISEASES   (Japan)

Author keywords

5 fluorouracil; Chemotherapy; Cisplatin; Pancreatic cancer; Radiotherapy

Indexed keywords

CISPLATIN; FLUOROURACIL; GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; BILE DUCT OBSTRUCTION; BLOOD TOXICITY; CANCER CONTROL; CANCER GROWTH; CANCER RADIOTHERAPY; CANCER STAGING; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; FEMALE; GASTROINTESTINAL HEMORRHAGE; HUMAN; HYPERBILIRUBINEMIA; MALE; MAXIMUM TOLERATED DOSE; MUCOSA INFLAMMATION; MULTIMODALITY CANCER THERAPY; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PANCREAS CANCER; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; RADIATION DOSE; SURVIVAL RATE; THROMBOCYTOPENIA; VOMITING;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CISPLATIN; COMBINED MODALITY THERAPY; DOSE FRACTIONATION; DRUG ADMINISTRATION SCHEDULE; FEMALE; FLUOROURACIL; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASM STAGING; NEUTROPENIA; PANCREATIC NEOPLASMS; REMISSION INDUCTION; SURVIVAL RATE; THROMBOCYTOPENIA;

EID: 33750142769     PISSN: 03682811     EISSN: 14653621     Source Type: Journal    
DOI: 10.1093/jjco/hyl064     Document Type: Article

References (27)

1. Michaud DS. Epidemiology of pancreatic cancer. Minerva Chir 2004;59:99-111.
2. Li D, Xie K, Wolff R, Abbruzzese JL. Pancreatic cancer. Lancet 2004;363:1049-57.
3. Willett CG, Czito BG, Bendell JC, Ryan DP. Locally advanced pancreatic cancer. J Clin Oncol 2005;23:4539-44.
4. The Gastrointestinal Tumor Study Group. Therapy of locally unresectable pancreatic carcinoma: A randomized comparison of high dose (6000 rads) radiation alone, moderate dose radiation (4000 rads + 5-fluorouracil), and high dose radiation + 5-fluorouracil. Cancer 1981;48:1705-10.
5. The Gastrointestinal Tumor Study Group. Treatment of locally unresectable carcinoma of the pancreas: Comparison of combined-modality therapy (chemotherapy plus radiotherapy) to chemotherapy alone. J Natl Cancer Inst 1988;80:751-5.
6. Saunder MI. Programming of radiotherapy in the treatment of non-small-cell lung cancer - a way to advance care. Lancet Oncol 2001;2:401-8.
7. Horiot JC, Bontemps P, van den Bogaert W, Le Fur R, van den Weijngaert D, Bolla M, et al. Accelerated fractionation (AF) compared to conventional fraction (CF) improves loco-regional control in the radiotherapy of advanced head and neck cancers: Results of the EORTC 22851 randomized trial. Radiother Oncol 1997;44:111-21.
8. Saunders MI, Dische S, Barrett A, Parmar M, Harvey A, Gibson D. Continuous hyperfractionated accelerated radiotherapy (CHART) versus conventional radiotherapy in non-small-cell lung cancer: A randomised multicentre trial. Lancet 1997;350:161-5.
9. Schuster-Uitterhoeve AL, Gonzalez Gonzalez D, Blank LE. Radiotherapy with multiple fractions per day in pancreatic and bile duct cancer. Radiother Oncol 1986;7:205-13.
10. Seydel HG, Stablein DM, Leichman LP, Kinzie JJ, Thomas PR. Hyperfractionated radiation and chemotherapy for unresectable localized adenocarcinoma of the pancreas. The Gastrointestinal Tumor Study Group experience. Cancer 1990;65:1478-82.
11. Prott FJ, Schonekaes K, Preusser P, Ostkamp K, Wagner W, Micke O, et al. Combined modality treatment with accelerated radiotherapy and chemotherapy in patients with locally advanced inoperable carcinoma of the pancreas: Results of a feasibility study. Br J Cancer 1997;75:597-601.
12. Luderhoff EC, Gonzalez Gonzalez D, Bakker P. Pilot study in locally advanced unresectable pancreas carcinoma using a combination of accelerated radiotherapy and continuous infusion of 5-fluorouracil. Radiother Oncol 1996;40:241-3.
13. Ashamalla H, Zaki B, Mokhtar B, Colella F, Selim H, Krishnamurthy M, et al. Hyperfractionated radiotherapy and paclitaxel for locally advanced/ unresectable pancreatic cancer. Int J Radiat Oncol Biol Phys 2003;55:679-87.
14. Ueno H, Okusaka T, Ikeda M, Tokuuye K. Phase I study of hyperfractionated radiation therapy with protracted 5-fluorouracil infusion in patients with locally advanced pancreatic cancer. Oncology 2004;67:215-21.
15. Shirasaka T, Shimamoto Y, Ohshimo H, Saito H, Fukushima M. Metabolic basis of the synergistic antitumor activities of 5-fluorouracil and cisplatin in rodent tumor models in vivo. Cancer Chemother Pharmacol 1993;32:167-72.
16. Skov K, MacPhail S. Interaction of platinum drugs with clinically relevant x-ray doses in mammalian cells: A comparison of cisplatin, carboplatin, iproplatin, and tetraplatin. Int J Radiat Oncol Biol Phys 1991;20:221-5.
17. Sun JR, Brown JM. Lack of differential radiosensitization of hypoxic cells in a mouse tumor at low radiation doses per fraction by cisplatin. Radiat Res 1993;133:252-6.
18. Schaake-Koning C, van den Bogaert W, Dalesio O, Festen J, Hoogenhout J, van Houtte P, et al. Effects of concomitant cisplatin and radiotherapy on inoperable non-small-cell lung cancer. N Engl J Med 1992;326: 524-30.
19. Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982;5:649-55.
20. US Food and Drug Administration, Center for Drug Evalution and Research. Oncology Tools, Toxicity Criteria. Available from: http://www.fda.gov/ cder/cancer/toxicityframe.htm.
21. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1-10.
22. Sobin LH, Wittekind CH, editors. International Union Against Cancer (UICC). TNM Classification of Malignant Tumors. 5th edn. New York: John Wiley & Sons, Inc. 1997.
23. Lokich JJ, Ahlgren JD, Gullo JJ, Philips JA, Fryer JG. A prospective randomized comparison of continuous infusion fluorouracil with a conventional bolus schedule in metastatic colorectal carcinoma: A Mid-Atlantic Oncology Program Study. J Clin Oncol 1989;7:425-32.
24. Nakajima Y, Miyamoto T, Tanabe M, Watanabe I, Terasima T. Enhancement of mammalian cell killing by 5-fluorouracil in combination with X-rays. Cancer Res 1979;39:3763-7.
25. Smalley SR, Kimler BF, Evans RG. 5-Fluorouracil modulation of radiosensitivity in cultured human carcinoma cells. Int J Radiat Oncol Biol Phys 1991;20:207-11.
26. Burris HA, Moore MJ, Anderson J, Green MR, Rothenberg ML, Modiano MR, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: A randomized trial. J Clin Oncol 1997;15:2403-13.
27. Lawrence TS, Eisbruch A, Shewach DS. Gemcitabine-mediated radiosensitization. Semin Oncol 1997;24:S7:24-8.