Zheng 2017.

Study characteristics
Methods	Single‐centre RCT conducted in China with recruitment by 2 departments. The paper was translated, originally written in Mandarin. RCT study on chemoradiotherapy with adjuvant surgery in later‐stage cervical cancer since June 2012. These are the preliminary results of the study. We emailed the corresponding author to ask for any more up‐to‐date results, no reply to date. Primary efficacy endpoint of the chemoradiotherapy group was 5‐year survival rate > 60%. Authors chose lower point of the 5‐year survival rate (60–70%) according to NCI series of studies, because Stage IIIA and IIIB cervical cancer will be included in a further study. 5‐year survival rate was set to be ≥ 70%, and increased by 10% compared to chemoradiotherapy group to be statistically significant (significance level 5% with 80% power). Recruiting period was set for 3 years; follow‐up was 5 years. Lost to follow‐up rate was set for 10%. Median survival rates for chemoradiotherapy + surgery group was set for 9.7 years and for chemoradiotherapy group was 6.8 years. Power and sample size calculation program software was used to calculate the sample size for each group, which was 327. If sample size is not reached before end of recruiting period, this study will be terminated, but statistical analysis will be performed. Inclusion criteria: women with cervical cancer; stage confirmed by 2 gynaeoncologists (oncologist specialised in gynaecology): Stage IB (tumour dimension > 4 cm), Stage IIA–IIIB (2009 FIGO cancer stage system). All participants were followed up for > 5 years, and the case lost to follow‐up from the date of loss to follow‐up was calculated as death. Statistical analysis using SPSS 20.0 software. The Chi2 test or Fisher exact probability method was used to compare the number of data sets. The rate was calculated by Kaplan‐Meier method and the survival curve was drawn. The inspection level was set as α = 0.05. Intentionality score was used for statistical analysis (intention‐to‐treat analysis).
Participants	102 eligible participants were included before this interim analysis, including 52 in the chemoradiotherapy + surgery group and 50 in the chemoradiotherapy group. All the participants were numbered according to the enrolment order. Currently, 102 participants enrolled in study, with the numbers ranging from 1 to 102. Each participant was randomly assigned to 1 and 2 using a random number generator, with 1 as the chemoradiotherapy + surgery group and 2 as the chemoradiotherapy group.
Interventions	Chemoradiotherapy (control group) Chemoradiotherapy + surgery Chemoradiotherapy Women who met the inclusion criteria were first treated with CCRT in the radiotherapy department. Linear accelerator was used for external pelvic irradiation, and the intracavitary 192Ir was used for radiotherapy. Stage 1: the whole basin irradiation before and after the field or left and right field irradiation, 4 or 5 times a week, each time 2.25 Gy or 1.8 Gy, pelvic centre total dose 30 Gy. Stage 2: the lead block protected the uterus, and the uterus continued to be irradiated from the front and back, 5 times a week, 1.8–2.0 Gy each time, and the total periuterine dose 15–20 Gy. At the beginning of the second stage of external irradiation, intracavitary and the back of the cavity were performed at the same time once a week, with 4.6–7.0 Gy at 'point A' and total of 35–42 Gy at 'point A'. Chemotherapy regimen: cisplatin alone: 35–40 mg/m2, once a week. Surgical treatment Participants in the chemoradiotherapy + surgery group underwent radical surgery in the hospital 4–6 weeks after the completion of CCRT. For radical total hysterectomy and pelvic lymphadenectomy, 3 cm of parastatal and vaginal tissues were removed.
Outcomes	Recurrence OS rate Outcome indicators Short‐term efficacy evaluation: evaluate the efficacy according to the tumour regression before and after treatment: complete remission: complete regression of the tumour by gynaecological examination and imaging examination; partial remission: tumour volume reduction ≥ 50%; stability of disease: tumour volume reduction ≤ 50%; progression of disease: tumour enlargement or presence of new lesions. Complete and partial response means an effective treatment.
Notes	6 participants in the chemoradiotherapy + surgery group refused surgery. In the chemoradiotherapy group, 2 participants chose surgery due to tumour regression, 4 participants automatically requested surgery.   Short‐term efficacy evaluation at the end of CCRT Chemoradiotherapy + surgery group: complete remission rate 80.8% (42/52); partial remission rate 13.5% (7/52); stability of disease rate 5.8% (3/52); progression of disease rate 0%. Chemoradiotherapy group: complete response rate 72.0% (36/50); partial response rate 20.0% (10/50), stability of disease rate 4.0% (2/50); progression of disease rate 4.0% (2/50). Chi2 analysis of Kendall's Tau‐b scale data showed no statistically significant difference between groups (P = 0.290). The postoperative pathological results of the chemoradiotherapy + surgery group showed that after radiotherapy, the residual rate of non‐cancer was 82.7%, and the residual rate of cancer was 5.8%. PFS time PFS time was defined as the survival time from the end of chemoradiotherapy to the end of follow‐up without local tumour progression or recurrence. Since it is impossible to judge the progression of the lost follow‐up cases, to avoid overestimating the therapeutic effect, such participants were treated as if they had no progression. The PFS time of the chemoradiotherapy + surgery group was 3–40 months, median survival time was 23 months and 3‐year survival rate was 73.1%. PFS time in the chemoradiotherapy group was 5–41 months, median survival time was 22 months and 3‐year survival rate was 64.8%. Kaplan‐Meier Survival analysis showed that PFS rate was similar between groups (Chi2 = 0.092, P = 0.761). Total survival time OS was defined as the survival time of participants from the enrolment time to the end of follow‐up, and the participants lost to follow‐up were treated as deaths. OS time in the chemoradiotherapy + surgery group was 6–40 months, median survival time was 23 months and 3‐year survival rate was 82.7%. Total survival time in the chemoradiotherapy group was 5–41 months, median survival time was 22.5 months and 3‐year survival rate was 81.8%. Kaplan‐Meier survival analysis showed that the OS rate was similar between groups (Chi2 = 0.338, P = 0.561).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Each participant was randomly assigned to 1 and 2 using a random number generator.
Allocation concealment (selection bias)	Unclear risk	Not reported.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Blinding not possible but should not have introduced bias for objective outcomes.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Unclear.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	102/102 (100%) women analysed.
Selective reporting (reporting bias)	Unclear risk	HRs were not reported in the paper.
Other bias	Unclear risk	Insufficient information to permit judgement.

BOPM: bleomycin, vincristine, mitomycin and cisplatin; CCRT: concurrent chemoradiotherapy; CI: confidence interval; CT: computed tomography; DFS: disease‐free survival; EBRT: external beam radiotherapy; EFS: event‐free survival; FIGO: International Federation of Gynecology and Obstetrics; GOG: Gynecologic Oncology Group; HR: hazard ratio; MRI: magnetic resonance imaging; NACT: neoadjuvant chemotherapy; NCI: National Cancer Institute; OS: overall survival; PFS: progression‐free survival; RCT: randomised controlled trial; RH: radical hysterectomy; RR: risk ratio; SAE: serious adverse event; WHO: World Health Organization.