Phase III Trial of Radiosensitizer PR-350 Combined with Intraoperative Radiotherapy for the Treatment of Locally Advanced Pancreatic Cancer

Pancreas

Volumn 28, Issue 3, 2004, Pages 330-334

  Sunamura, Makoto ^a   Karasawa, Katsuyuki ^b   Okamoto, Atutake ^b   Ogata, Yoshiro ^c   Nemoto, Kenji ^a   Hosotani, Ryo ^d   Nishimura, Yasumasa ^e   Matsui, Kenichi ^f   Matsuno, Seiki ^a  

^a TOHOKU UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b TOKYO METROPOLITAN KOMAGOME HOSPITAL   (Japan)

^c TOCHIGI CANCER CENTER   (Japan)

^d KOBE CITY MEDICAL CENTER GENERAL HOSPITAL   (Japan)

^e KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^f TOHO UNIVERSITY   (Japan)

Author keywords

Intraoperative radiology; Pancreatic cancer; PR 350; Radiosensitizer

Indexed keywords

2 NITROIMIDAZOLE DERIVATIVE; DORANIDAZOLE; RADIOSENSITIZING AGENT; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER MORTALITY; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER SURGERY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECT; DRUG SAFETY; FEMALE; FOLLOW UP; HUMAN; HUMAN TISSUE; MALE; PANCREAS CANCER; PEROPERATIVE CARE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; STATISTICAL SIGNIFICANCE; TUMOR VOLUME;

ADENOCARCINOMA; AGED; COMBINED MODALITY THERAPY; FEMALE; HUMANS; IMIDAZOLES; INTRAOPERATIVE PERIOD; MALE; MIDDLE AGED; PANCREATIC NEOPLASMS; RADIATION-SENSITIZING AGENTS; SURVIVAL ANALYSIS;

EID: 1842587450     PISSN: 08853177     EISSN: None     Source Type: Journal    
DOI: 10.1097/00006676-200404000-00023     Document Type: Article

References (13)

1. Abe M, Arakawa M. Fundamental studies on surgical irradiation. Histological and hematological changes following irradiation during laparotomy of dogs. Jpn Soc Cancer Ther. 1967;2:271-278.
2. Sunamura M, Kobari M, Lozonschi L, et al. Intraoperative radiotherapy for pancreatic adenocarcinoma. J Hepatobiliary Pancreat Surg. 1998;5:151-156.
3. Goldson AL, Ashaveri E, Espinoza MC, et al. Single high dose intraoperative electrons for advanced stage pancreatic cancer: phase I pilot study. Int J Radiar Oncol Biol Phys. 1981;7:869-874.
4. Overgaard J, Sand Hansen H, Andersen AP, et al. Misonidazole combined split-course radiotherapy in the treatment of invasive carcinoma of larynx and pharynx. Report from the Dahanca 2 study. Int J Radiat Oncol Biol Phys. 1989;16:1065-1068.
5. Overgaard J. Sensitization of hypoxic tumor cells. Clinical experience. Int J Radiat Oncol Biol Phys. 1989;56:801-811.
6. Lee D-J, Phillips TL, Coleman CN, et al. Logistics in designing clinical trials for etanidazole (SR2508): an RTOG experience. Int J Radiat Oncol Biol Phys. 1992;22:569-571.
7. Coleman CN, Buswell L, Noll L, et al. The efficacy of pharmacokinetic monitoring and dose modification of etanidazole on the incidence of neurotoxicity: results from a phase II trial of etanidazole and radiation therapy in locally advanced prostate cancer. Int J Radiat Oncol Biol Phys. 1992;22:565-568.
8. Maruyama C, Suzuki A, Sato C, et al. Radiosensitization by a new potent nucleoside analog: 1-(1′,3′,4′-trihydroxy-2′ -butoxy)methyl-2-nitroimidazole(PR-343). Int J Radiat Oncol Biol Phys. 1993;26:433-443.
9. Oya N, Shibamoto Y, Sasaki K, et al. Optical isomers of a new 2-nitroimidazole nucleoside analog (PR-000350 series): radiosensitization efficiency and toxicity. Int J Radiat Oncol Biol Phys. 1995;33:119-127.
10. Sunamura M, Matsuno S, Okamoto A, et al. Phase I clinical trial for the effect of a radiosensitizer, PR-350 (Doranidazole) combined with intraoperative radiation therapy in the treatment of pancreatic carcinoma. Suizo. 2003;18.
11. Rothenberg ML, Moore MJ, Cripps MC. et al: A phase II trial of gemcitabine in patients with 5-FU-refractory pancreas cancer. Ann Oncol. 1996;7:347-353.
12. Nishimura Y, Shibamoto Y, Hosotani R, et al. IORT for pancreatic cancer: the Kyoto University experience. Front Radiat Ther Oncol. 1997;31:184-188.
13. Li C-P, Chao Y, Chi K-H, et al. Concurrent chemoradiotherapy treatment of locally advanced pancreatic cancer: gemcitabine versus 5-fluorouracil, a randomized controlled study. Int J Radiat Oncol Biol Phys. 2003;57:98-104.