Landoni 1997.
Study characteristics | ||
Methods | Randomised controlled trial 1986 to 1991; Milan, Italy | |
Participants | 337 patients with stage IB or IIA cervical cancer: 46 with cervical adenocarcinoma | |
Interventions | Surgery consisted of a Class III radical abdominal hysterectomy n + 26. Adjuvant radiotherapy was given if at least 1 pathological risk factor (stage > pT2a, less than 3 mm uninvolved stroma, cut through, lymph‐node metastases) Radiotherapy included external beam pelvic irradiation plus brachytherapy. Total dose at point A ranged 70 to 90 Gy (median 76 Gy) N = 20. |
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Outcomes | 5‐year overall survival: 70% after primary surgery (N = 26) versus 59% after primary radiotherapy (N = 20). No evidence of disease at 5 years: 66% after surgery versus 47% after radiotherapy Complications surgery‐related 28%, radiation‐related 12% For patients with cervical adenocarcinoma, the 20‐year overall survival: 71% and 47% for surgery and radiotherapy respectively. |
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Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | |
Allocation concealment (selection bias) | Low risk | |
Blinding (performance bias and detection bias) 5 yr survival | High risk | In the follow‐up primary therapy was obvious |
Blinding (performance bias and detection bias) complications | High risk | |
Incomplete outcome data (attrition bias) All outcomes | Low risk | |
Selective reporting (reporting bias) | Low risk | |
Other bias | Low risk |