Koizumi 2013.
Methods | Japanese multicenter RCT (14 centers in Japan), Phase II | |
Participants |
Number of participants: 93 (December 2008 to February 2012) Number randomized: Experimental group (TSU‐68 + S‐1/CDDP): 46 Control group (S‐1/CDDP): 47 Number evaluated: Experimental group: 45, age (median and range): 62 (30 ‐ 74) years Control group: 46, age (median and range): 63.5 (44 ‐ 76) years Diagnosis: patients with chemotherapy‐naïve unresectable or recurrent AGCs Inclusion: eligible patients should: be > 20 years; with histologically‐ or cytologically‐confirmed adenocarcinoma; unresectable or recurrent gastric cancer; no prior systemic treatment. Recurrent patients were eligible if the last dose of postoperative adjuvant chemotherapy had been received at least 180 days before the start of the study |
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Interventions |
Experimental group : TSU‐68: 800 mg m–2 twice a day day 1 – 35 every 5 weeks; S‐1: 40 – 60 mg m–2 twice a day day 1 – 21 every 5 weeks; CDDP: 60 mg m–2 i.v. on day 8 Control group: S‐1: 40 – 60 mg m–2 twice a day day 1 – 21 every 5 weeks; CDDP: 60 mg m–2 i.v. on day 8 The treatments were continued until 1 of the following occurred: progressive disease (PD), unacceptable toxicity, withdrawal of participant consent (regardless of toxicity), or termination of treatment at the discretion of the attending physician |
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Outcomes |
Duration of follow‐up (median): not mentioned PFS, OS, overall response, adverse events (reported by different symptoms, no data for any adverse event) |
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Notes | This trial was supported by Taiho Pharmaceutical Co., Ltd | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was performed according to the minimization method |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The open‐label design may introduce performance bias (e.g. through stress‐related mechanisms) |
Blinding of outcome assessment (detection bias) OS, Serious adverse events | Low risk | These outcomes were unlikely to be affected by the blinding status of assessors |
Blinding of outcome assessment (detection bias) PFS, Response, quality of life & adverse events | Low risk | All measured images were assessed by a central imaging review committee |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 91 randomized participants were included in analysis (97.8%) |
Selective reporting (reporting bias) | Low risk | No prior protocol was available but all important outcomes were reported |
Other bias | Low risk | No obvious potential source of bias |