Japanese journal of clinical oncology
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Jpn. J. Clin. Oncol. · Jan 2005
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialRandomized controlled trial to evaluate radiotherapy +/- endocrine therapy versus endocrine therapy alone for PSA failure after radical prostatectomy: Japan Clinical Oncology Group Study JCOG 0401.
A randomized controlled trial has started in Japan to evaluate radiotherapy and endocrine therapy for prostate-specific antigen (PSA) failure after radical prostatectomy. Patients who have PSA failure after radical prostatectomy for localized prostate cancer (T1-2N0M0) are randomized into treatment groups of either radiotherapy +/- endocrine therapy or endocrine therapy alone. ⋯ The primary end-point is time to treatment failure (TTF) of bicalutamide, and secondary end-points are TTF of protocol treatment, progression-free survival, overall survival, adverse events and quality of life (QOL). The Clinical Trial Review Committee of the JCOG approved the protocol on April 13, 2004, and the study was activated on May 17, 2004.
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Jpn. J. Clin. Oncol. · Jun 2003
Randomized Controlled Trial Multicenter Study Clinical TrialResults of a randomized trial with or without 5-FU-based preoperative chemotherapy followed by postoperative chemotherapy in resected colon and rectal carcinoma.
Our previous study confirmed the efficacy of postoperative treatment with mitomycin C (MMC) and oral 5-fluorouracil (5-FU) for colorectal cancer. The 2nd trial was designed to evaluate the effectiveness of additional preoperative chemotherapy to postoperative treatment with MMC and oral 5-FU for curatively resected colorectal cancer patients. ⋯ In the PC group, the 5-year survival rate was nearly identical with that seen in our earlier research using the same regimen, reaffirming the clinical effectiveness of postoperative MMC by protracted intravenous infusion and oral 5-FU. However, our findings did not support additional preoperative chemotherapy for curative resection in patients with colorectal cancer.
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Jpn. J. Clin. Oncol. · Feb 1999
Randomized Controlled Trial Clinical TrialAntiemetic efficacy of granisetron: a randomized crossover study in patients receiving cisplatin-containing intraarterial chemotherapy.
Cisplatin (CDDP) is one of the most active chemotherapeutic agents but is among the most emetogenic drugs. The emetic side-effects of CDDP-containing intraarterial chemotherapy have not been evaluated in a prospective randomized trial and the efficacy of serotonin antagonists in preventing the emesis associated with this method of CDDP administration has not been assessed. ⋯ A single prophylactic infusion of granisetron was effective in preventing the nausea and vomiting associated with intraarterial CDDP-containing therapy.
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Jpn. J. Clin. Oncol. · Jun 1996
Randomized Controlled Trial Comparative Study Clinical TrialA randomized cross-over trial of granisetron and dexamethasone versus granisetron alone: the role of dexamethasone on day 1 in the control of cisplatin-induced delayed emesis.
We studied the role of dexamethasone (DEX) administered on day 1 in controlling cisplatin-induced delayed emesis. Forty patients were randomly allocated to receive either granisetron (GRN) and DEX on day 1, or the same dose of GRN alone. On days 2-5, all the patients received metoclopramide and DEX. ⋯ The mean numbers of emetic episodes on days 1-3 were 0.036, 0.46 and 0.36 for GRN and DEX, and 0.39, 0.89 and 0.57 for GRN alone, respectively (P<0.01 on day 1). Hiccups and restlessness were noted in 38% and 33% of cycles, respectively. Addition of DEX to GRN on day 1 thus enhanced the control of delayed emesis.
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Jpn. J. Clin. Oncol. · Jun 1995
Randomized Controlled Trial Multicenter Study Clinical TrialFive-year results of a randomized controlled trial of adjuvant chemotherapy for curatively resected colorectal carcinoma. The Colorectal Cancer Chemotherapy Study Group of Japan.
In order to evaluate the significance of postoperative adjuvant chemotherapy for colorectal carcinoma, the Colorectal Cancer Chemotherapy Study Group, from 140 leading hospitals in Japan, conducted a prospective, randomized, controlled trial on patients who had undergone curative resections for colorectal carcinomas during the period from February 1984, to December 1985. The regimens for colon cancer were, Arm I: mitomycin C [intraoperative portal vein bolus (12 mg/m2) + postoperative, twice weekly and then three times bimonthly for six months intermittent i.v. bolus (6 mg/m2)] + 5-fluorouracil (5-FU) 200 mg/body/day p.o. for six months; Arm II: postoperative twice weekly and then three times bimonthly intermittent i.v. bolus mitomycin C (6 mg/m2) for six months + 5-FU 200 mg/body/day p.o. for six months; Arm III: surgery alone. The regimens for rectal cancer were, Arm IV: same as Arm I, with superior rectal artery infusion of the same mitomycin C dose instead of portal vein infusion; Arm V: same as Arm II; Arm VI: same as Arm III. ⋯ We conclude the adjuvant use of long term oral 5-FU and intermittent mitomycin C (i.v.) to improve the survival rate of patients with curatively resected rectal cancer. Further comparative study is, however, recommended to confirm the effectiveness of 5-FU alone and the combination of 5-FU and mitomycin C. Regional chemotherapy made no contribution to reducing an hepatic recurrence of colon cancer or a local recurrence of rectal cancer.