Perez 1987.
Study characteristics | ||
Methods | Single‐centre RCT conducted in Washington University, USA. Women were randomised to radiotherapy + RH or radiotherapy alone. |
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Participants | 118 eligible women with Stage IB to IIA cervical cancer. It was not reported how many women were Stage IB1 and how many Stage IB2 (the latter group is area of interest for this Cochrane Review). Women with barrel‐shaped cervix (endocervical lesion with cervix diameter > 5 cm) were excluded. Age distribution was comparable between groups. No additional information given regarding the age (i.e. range, median age, mean age) of the participating women. In women treated with radiotherapy + RH (62 women) Stage IB women: 43 had squamous cell carcinoma, 4 had adenocarcinoma and 1 had adenosquamous carcinoma. Stage IIA women: 14 had squamous cell carcinoma. In women treated with radiotherapy alone (56 women) Stage IB women: 35 had squamous cell carcinoma, 4 had adenocarcinoma and 1 had adenosquamous carcinoma. Stage IIA women: 16 had squamous cell carcinoma. |
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Interventions |
2000 Gy whole pelvis irradiation and 1 intracavitary insertion for 5000–6000 milligram‐hours, followed 2–6 weeks later by a RH and bilateral pelvic lymphadenectomy (up to the bifurcation of the common iliac chain). The dose to the cervix was about 7000 Gy and to the pelvic lymph nodes 3000 Gy.
1000–2000 Gy delivered to the whole pelvis and an additional parametrial dose to total of 5000 Gy to the external iliac lymph nodes combined with 2 intracavitary insertions for a total of approximately 7500 milligram‐hours (6500–7000 Gy to 'point A'). The dose to the paracervical tissues was about 8500 Gy and to the pelvic lymph nodes 6000 Gy. |
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Outcomes | 5‐year tumour‐free actuarial survival Sites of failure after therapy Complications |
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Notes | All women were available for 5‐year follow‐up and the median period of observation was 6 years. No women were lost to follow‐up. In the women with Stage IB, 48 received preoperative radiotherapy + RH and 40 received radiotherapy alone. In women with Stage IIA, 14 received preoperative radiotherapy + RH and 16 received radiotherapy alone. 5‐year, tumour‐free actuarial survival for Stage IB women was 80% in the preoperative radiotherapy + RH group and 89% in the radiotherapy alone group. In Stage IIA, 5‐year survival was 79% in the preoperative radiotherapy + RH group and 56% in the radiotherapy alone group. The difference was not statistically significant. An analysis of the chronological distribution of recurrences showed that 85% of the failures occurred within 3 years from therapy, at about the same rate in both groups. The overall incidence of major complications was 11% in the preoperative radiotherapy + RH group and 16% in the radiotherapy alone group. This difference was not statistically significant. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were … randomised by the flip of a coin". |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind participants and clinicians to these interventions. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 118/118 randomised women were analysed and 0 women were lost to follow‐up. |
Selective reporting (reporting bias) | High risk | 5‐year tumour‐free survival was reported but OS was not, even though the number of deaths would have been known. |
Other bias | Unclear risk | Insufficient information to assess whether an additional risk of bias existed. |