Cocconi 2003.

Methods	Multicentre RCT 2 arms Quality score: A
Participants	n = 200 Metastatic disease: 85%
Interventions	FAMTX: MTX 1500 mg/m² d1; 5‐FU 1500 mg/m²; Lv 7.5 mg/m² p.o. every 6 hrs d 1‐3, adriamycin 30 mg/m² d 15, repeated at d 29 versus PELF: cisplatin 40 mg/m² d1, 5, etoposide 30 mg/m² d 1, 5; Lv 100 mg/m² d 1‐4, 5‐FU 300 mg/m² d 1‐4, repeated at d 22
Outcomes	Median survival Response rates Time to progression Toxicity
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not stated
Allocation concealment (selection bias)	Low risk	Eligible patients were centrally randomised by the operational office of GOIRC (Parma, Italy)
Incomplete outcome data (attrition bias) efficacy	Unclear risk	Thirteen of the 200 randomised patients (six in the PELF and seven in the FAMTX group) did not begin the assigned chemotherapy and were not evaluated for toxicity. Reasons were not provided, and it is possible that this proportion could have an impact on analysis. The response of 15 patients in the PELF group and 14 in the FAMTX group were unevaluable or not evaluated for the following reasons: the treatment was never started (five versus five), protocol violations (zero versus one), insufficient treatment due to early death (five versus three), refusal (four versus two), early discontinuation due to toxicity (zero versus three) or severe medical events (one versus zero)
Incomplete outcome data (attrition bias) safety	Unclear risk	Thirteen of the 200 randomised patients (six in the PELF and seven in the FAMTX group) did not begin the assigned chemotherapy and were not evaluated for toxicity. Reasons were not provided, and it is possible that this proportion could have an impact on analysis.
Selective reporting (reporting bias)	Unclear risk	Toxicity was evaluated in all of the patients receiving at least one dose of chemotherapy whether they were eligible or not
Other bias	Unclear risk	N/A
Blinded review of CT/MRI‐scans?	Unclear risk	Response was assessed by the clinical investigators at each participating unit, and centrally reviewed in the case of CR, PR, no change for more than 6 months, or in the case of patients who underwent gastric resection at the end of the chemotherapy programme.