A confirmatory trial of hysterectomy with minimal parametrectomy for stage IB1 cervical cancer involving a tumor diameter of 2 cm or less: a Japan Clinical Oncology Group study (JCOG1101)

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OBJECTIVE: The standard surgery for stage IB uterine cervical cancer is radical hysterectomy (RH). However, RH is highly invasive, and there is a need to establish less invasive techniques. METHODS: We conducted a prospective, single-arm trial to evaluate the efficacy and safety of modified radical hysterectomy (MRH)in patients with International Federation of Gynecology and Obstetrics 2008 stage IB1 cervical cancer involving a tumor diameter of ≤2 cm measured on magnetic resonance imaging. The protocol treatment consisted of MRH and adjuvant (chemo)radiotherapy if indicated. The primary endpoint was 5-year overall survival (OS). The expected OS was set at 95.8%; i.e., the OS of RH in our previous observational study. RESULTS: Of 225 eligible patients, 193 (85.8%) had pT1b1 (Union for International Cancer Control 7th) disease, and 184 (81.8%) had a pathological maximum tumor diameter of ≤2 cm. Parametrial involvement, lymph node metastasis, stromal invasion involving ≥2/3 of the stroma, and surgical margins of <1 cm (including carcinoma in situ) were observed in 3 (1.3%), 16 (7.1%), 30 (13.3%), and 11 (4.9%) patients, respectively. The 5-year OS and relapse-free survival rates were 98.2% (90% confidence interval [CI]=96.0%-99.2%) and 94.7% (95% CI=90.8%-96.9%), respectively. The median time to the disappearance of residual urine after urethral catheter removal was 1 day. There were no treatment-related deaths. Grade 3/4 adverse events were observed in 17 patients (7.6%). CONCLUSION: MRH may be as effective as and less invasive than RH for stage IB1 uterine cervical cancer involving a tumor diameter of ≤2 cm. TRIAL REGISTRATION: Japan Registry of Clinical Trials Identifier: jRCTs031180167.

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