Boonstra 2011.
| Methods | Parallel RCT (1989‐1996) Randomization stratified by age (< 50; 51‐60; > 60), gender (male; female), weight loss (kg) in the past 4 months (0‐5; 6‐10; > 10), and length of the tumor (cm) as measured by esophagogastroscopy (1‐3; 4‐6; 7‐10; > 10) |
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| Participants | 169 participants, Netherlands, multicenter (6 centers), but 122/169 were from 1 center
100% squamous cell cancer of thoracic esophagus T1‐3, any N, M0 (M1a eligible if distal esophageal cancer AND suspected celiac nodes) < 80 years of age Karnofsky > 70 Upper, middle, and lower third esophageal tumors "Patients with previous malignancies were eligible if more than 5 years had elapsed from diagnosis without evidence of tumour recurrence; exceptions were made for adequately treated basal cell cancer of the skin or carcinoma in situ of the cervix" |
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| Interventions |
Preoperative chemo Cycle 1 Cisplatin (80 mg/m2 IV over 4 hours on day 1 of each cycle) Etoposide (100 mg/m2 IV over 2 hours on days 1 and 2 of each cycle) Etoposide (200 mg/m2 PO on days 3 and 5 of each cycle) Cycle 2 (as above, repeated on week 4) Participants with complete or partial responses received 2 additional cycles of chemotherapy on weeks 8 and 11, whereas nonresponding participants (stable disease or progressive disease) OR those with severe toxic side effects were referred for immediate surgery Surgery: esophagectomy (see details below) vs Esophagectomy • For upper half cancers, a right‐sided thoracotomy was performed • For lower half cancers, a transhiatal esophagectomy was done • En bloc resection of tumor and adjacent lymph nodes • "Left gastric artery was transected at its origin, with resection of local lymph nodes" • Gastric tube reconstruction or colonic interposition with a cervical anastomosis |
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| Outcomes | • Overall survival • Disease‐free survival • 30‐Day postoperative mortality • Complications |
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| Notes | Full report of KOK 1997 trial abstract Better median overall survival and disease‐free survival in preop chemo group. More pulmonary complications in preop chemo group, but no difference in other morbidity or mortality |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Not stated |
| Allocation concealment (selection bias) | Low risk | Not stated |
| Blinding (performance bias and detection bias) All outcomes | Low risk | For primary outcome of interest |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Not stated |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not stated |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Not stated |
| Selective reporting (reporting bias) | Unclear risk | Not stated |