BackgroundThe standard treatment for stage IB–IIB cervical cancer is radiotherapy or radical hysterectomy; after radical hysterectomy, adjuvant concurrent chemoradiotherapy is recommended for patients with high risk factors. However, adjuvant concurrent chemoradiotherapy can cause severe gastrointestinal and urinary toxicity.Primary ObjectiveTo assess whether postoperative adjuvant chemotherapy is not inferior to adjuvant concurrent chemoradiotherapy for overall survival in patients with high risk cervical cancer.Study HypothesisAdjuvant chemotherapy is not inferior to adjuvant concurrent chemoradiotherapy for overall survival and will reduce severe toxicities.Trial DesignPatients with high risk factors after radical hysterectomy will be randomized 1:1 to receive adjuvant concurrent chemoradiotherapy or adjuvant chemotherapy. Treatment will be started within 6 weeks of surgery. The concurrent chemoradiotherapy group will receive whole pelvis irradiation (50.4 Gy) and cisplatin (40 mg/m2/week). The chemotherapy group will receive paclitaxel (175 mg/m2) plus cisplatin (50 mg/m2) or carboplatin (AUC=6) every 3 weeks for six cycles.Major Inclusion/Exclusion CriteriaPatients with high risk stage IB–IIB cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma) who underwent radical hysterectomy are eligible for the study. High risk is defined as the presence of pelvic lymph node metastasis and/or parametrial invasion.Primary EndpointThe primary endpoint is overall survival.Sample Size250 patients in total are required.Estimated Dates for Completing AccrualThis study began in November 2019, and 250 patients will be accrued within 5 years.Trial Registration NumberThe study has been registered with the Japan Registry of Clinical Trials (jRCTs041190042).
Concurrent chemotherapy and radiotherapy in invasive cervical cancer patients with high risk factors
