Rotman 1990.

Methods	Multicentre, 2‐armed parallel, RCT conducted by the RTOG; study number RTOG 79‐20 Study duration: November 1979 to October 1986
Participants	Enrolled 367 women to receive either pelvic RT alone or pelvic + para‐aortic radiation. However, 23 participants had insufficient data for any evaluation, leaving 335 participants for final analysis. Inclusion criteria: cervical cancer stage IIB without clinical evidence of para‐aortic nodal involvement; and people with stages IB and IIA who had large tumour sizes (≥ 4 cm in lateral dimension) determined by digital examination. Exclusion criteria: Karnofsky performance status < 40; inadequate bone marrow reserve; poor renal function (urea > 30 mg%); and prior curative surgery. 73.1% of participants were diagnosed with cervical cancer stage IIB. The distribution of pretreatment characteristics of the participants including stage of disease, histological subtypes of cancer, proportion of participants undergoing para‐aortic node evaluation, age, and performance status were well balanced between groups.
Interventions	Control arm: pelvic RT Intervention arm: pelvic and para‐aortic RT RT technique: RT to the pelvis was accomplished through megavoltage equipment with energy of ≥ 60Co delivering a total mid‐depth dose of 40–50 Gy in 4.5–6.5 weeks. The dose rate was 1.6–1.8 Gy per day for 5 days per week. Either 2 fields or 4 fields (box technique) for field configuration during EBRT used. Maximum of 30 Gy was allowed to be delivered to the pelvis through opposing anterior‐posterior portals. Minimum of 20 Gy was to be delivered through opposing lateral portals to the mid depth on the central axis of the fields. Opposing fields were treated daily throughout the course of treatment. External RT was delivered prior to intracavitary applications. For participants given para‐aortic node RT, 44–45 Gy was delivered in 4.5–5 weeks. After completion of EBRT, all participants received additional RT delivered by intracavitary brachytherapy using radium or caesium sources delivering 30–40 Gy to Point A. No chemotherapy administered.
Outcomes	Primary endpoints: 2‐year and 5‐year overall survival Other endpoints: rate of complete response, locoregional control, time to distant metastases, disease‐free survival, and rate of severe (grade ≥ 3) complications
Notes	Median follow‐up time of the early report was 6 years. Rotman 1995 is updated results of Rotman 1990. In this updated report, every participant could have been followed up for at least 8 years, and 55% of the participants could have been followed up for at least 10 years. In Rotman 1995, the primary endpoints were the 5‐year and 10‐year overall survival. Other endpoints were rate of complete response, locoregional control, time to distant metastases, disease‐free survival, and rate of severe (grade ≥ 3) complications. The final analyses for this updated report were carried out among 337 participants (167 in pelvic only RT and 170 in pelvic plus para‐aortic RT). 30 cases that were included in the first report were subsequently excluded from all analyses in the updated report due to a withdrawal of 1 participating site and incomplete data.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	No methods of random sequence generation provided in the published article. Kathryn Winter, Co‐Director, Division of Biostatistics and Science, NRG Oncology SDMC/RTOG and Senior Director of Statistics, American College of Radiology; however, confirmed that this RCT (RTOG 7902) applied an algorithm that implemented a permuted block randomisation scheme (Winter 2017 [pers comm]).
Allocation concealment (selection bias)	Low risk	Central allocation using a telephone call to RTOG Headquarters was made where eligibility was confirmed to conceal allocation.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	No statement regarding blinding of participants and personnel; however, outcomes of interest were unlikely to be affected by lack of blinding of participants.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	No statement regarding blinding of outcome assessor; however, outcomes of interest were unlikely to be affected by lack of blinding of outcome assessment. There was a well‐defined protocol for post‐treatment surveillance.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Only 30 (8.2%) participants included in this report were subsequently excluded from all analyses in this updated report due to a withdrawal of 1 participating site and incomplete data.
Selective reporting (reporting bias)	High risk	No data on quality of life and cost‐effectiveness reported.
Other bias	Low risk	Data analysed according to an intention‐to‐treat basis.

3D‐CRT: 3‐dimensional conformal radiotherapy; CT: computed tomography; EBRT: external‐beam radiotherapy; ECOG: Eastern Cooperative Oncology Group; EF‐CCRT: extended‐field concurrent chemoradiation; EORTC: European Organisation for Research and Treatment of Cancer; FDG‐PET: ¹⁸F‐fluorodeoxyglucose positron emission tomography; FIGO: Federation of Gynecology and Obstetrics; HDR: high‐dose rate; IMRT: intensity‐modulated radiotherapy; MRI: magnetic resonance imaging; RCT: randomised controlled trial; RT: radiotherapy; RTOG: Radiation Therapy Oncology Group; WP‐CCRT: whole‐pelvis concurrent chemoradiation.