Preventive effect of goshajinkigan on peripheral neurotoxicity of FOLFOX therapy: a placebo-controlled double-blind randomized phase II study (the GONE Study).
We conducted a controlled double-blind randomized study in patients with advanced/recurrent colorectal cancer to investigate the efficacy of Goshajinkigan (GJG) for peripheral neurotoxicity induced by FOLFOX therapy. The primary endpoint is the incidence of peripheral neurotoxicity > or = Grade 2 after eight cycles of chemotherapy. The secondary endpoints are the incidence of peripheral neurotoxicity of each grade after each cycle, the psychometric properties of the FACT/GOG-Ntx, time to occurrence of neurotoxicity, time to treatment failure, progression-free survival, response rate and toxicity. Eighty patients are required in the study (40 patients per group).
Kono
Toru
T
Division of Gastroenterologic and General Surgery, Department of Surgery, Asahikawa Medical College, Asahikawa, Hokkaido, Japan. kono@asahikawa-med.ac.jp
Mishima
Hideyuki
H
Shimada
Mitsuo
M
Morita
Satoshi
S
Sakamoto
Junichi
J
D000293:Adolescent; D000964:Antimetabolites, Antineoplastic / Q000494:pharmacology / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D015179:Colorectal Neoplasms / Q000188:drug therapy; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004347:Drug Interactions; D004365:Drugs, Chinese Herbal / Q000494:pharmacology*; D005260:Female; D005472:Fluorouracil / Q000494:pharmacology / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000494:pharmacology / Q000627:therapeutic use; D008297:Male; D009367:Neoplasm Staging; D020258:Neurotoxicity Syndromes / Q000188:drug therapy*; D009944:Organoplatinum Compounds / Q000494:pharmacology / Q000627:therapeutic use; D000077150:Oxaliplatin; D010919:Placebos; D055815:Young Adult
D000964:Antimetabolites, Antineoplastic; D004365:Drugs, Chinese Herbal; D009944:Organoplatinum Compounds; D010919:Placebos; C119642:gosha-jinki-gan; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil