Bedenne 2007.
Methods | Randomized controlled study | |
Participants | Histologically proven epidermoid or adenocarcinoma of the thoracic esophagus. T3N0‐N1M0 (International Union Against Cancer criteria, 1987) ; Clinical and biologic eligibility for surgery or chemoradiation; no age limit; Feburary 1993 to December 2000; France (multi‐center) Participants with tumors within 18 cm from dental ridge or infiltrating gastric cardia, tracheobronchial involvement, visceral metastasis or supraclavicular nodes, weight loss more than 15%, symptomatic coronary heart disease, liver cirrhosis Child‐Pugh B/C or respiratory insufficieny were excluded. 444 participants eligible for the study, 259 of whom were randomized (242 male, 17 female) Participants randomized/analysed in this meta‐analysis: 259/259 Median follow‐up time was 47.4 months. |
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Interventions | All participants received induction chemoradiation initially. Participants who responded to induction chemoradiation (day 38 to day 41), were randomized to surgery versus further chemoradiation. Initially, split‐course and conventional radiotherapy were allowed (investigator's choice). From January 1999, only conventional radiotherapy was permitted. Radiotherapy treatment volumes included macroscopic tumor and lymph nodes, with a 3 cm proximal/distal margin and 2 cm radial margin. (3 or 4 fields, and treating all fields daily) Split‐course: 3 Gy per day (days 1 to 5, then days 22 to 26) to a total dose of 30 Gy. After randomization to further chemoradiation, 3 Gy per day (days 43 to 47) to a total dose of 45 Gy. Conventional: 2 Gy per fraction, 5 fractions per week to a total dose of 46 Gy. After randomization to further chemoradiation, 2 Gy per fraction, 5 fractions per week to a total dose of 66 Gy. Chemotherapy (arm B): 2 cycles of chemotherapy were delivered before random assignment, on day1 and day 22. After random assignment, three cycles were administered (day 43, day 64, day 92). Chemotherapy consisted of cisplatin 15 mg/m² (days 1 to 5), and continuous infusion flurouracil 800 mg/m² daily (days 1 to 5) Surgery (arm A): no particular type of surgery was required. Surgery was to be performed between days 50 and 60. |
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Outcomes | overall survival. Duration of hospital stay, quality of life, type of recurrence, procedures against dysphagia | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence was generated using a minimization program. |
Allocation concealment (selection bias) | Low risk | Allocation was done at a central site (FFCD Data center) |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The risk of bias for the primary outcome (overall survival) is objective and therefore low. However, the risk of bias from lack of blinding was high for subjective outcomes such as quality of life, use of salvage procedures for dysphagia, duration of hospital stay, and type of recurrence. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The risk of bias for the primary outcome (overall survival) is objective and therefore low. However, the risk of bias from lack of blinding was high for subjective outcomes such as quality of life, use of salvage procedures for dysphagia, duration of hospital stay, and type of recurrence. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Low risk | All pre‐specifed primary and secondary outcomes were reported |
Other bias | Unclear risk | Quality assurance of radiotherapy planning and delivery were not reported. Type and quality of surgeries performed were not audited or reported. |