A randomized phase III trial of adjuvant chemotherapy versus concurrent chemoradiotherapy (CCRT) for postoperative cervical cancer: Japanese Gynecologic Oncology Group study (JGOG1082).

Abstract

TPS6094 Background: Cervical cancer is one of the common gynecologic cancer and the incidence of invasive cervical cancer has increased over the past few decades, particularly in younger women. The standard treatment for stage IB to IIB cervical cancer is a radical hysterectomy. In Japan, more than 80% of institutions, radical hysterectomy is chosen as the primary treatment for patients with stage IB1 and IIA1 cervical cancer. Patients with high-risk factors would be recommend adjuvant concurrent chemoradiotherapy (CCRT). However, adjuvant CCRT might not reduce distant metastasis and might cause of severe gastrointestinal and urinal toxicity. To avoid those adverse events of adjuvant CCRT, many Japanese gynecologic oncologists perform chemotherapy as adjuvant therapy. In the first multi-institutional phase II trial conducted in stage IB-IIA cervical cancer with pelvic lymph node metastasis (JGOG1067), we found a 5-years disease free-survival rate of 86.5%, suggesting the adjuvant chemotherapy had promising efficacy and would be feasible for a long time. No prospective study reported that adjuvant chemotherapy would improve overall survival in patients with the high-risk cervical cancer. Methods: High risk stage IB-IIB cervical cancer patients who underwent radical hysterectomy are eligible for the study. Patients with high risk are defined as those with pelvic lymph-node metastasis and/or parametrial invasion. Patents with SCC, adenocarcinoma, adenosquamous cell carcinoma are eligible for the study. After providing informed consent, patients are randomized on a 1:1 basis to receive CCRT or chemotherapy. Randomization is stratified by the faculty, FIGO stage, and pathological subtype (SCC or non-SCC). Treatment have to be started within 6 weeks after surgery. CCRT group is given whole pelvis irradiation 50.4Gy and cisplatin (40mg/m2/week). Chemotherapy group is given paclitaxel (175mg/m2) plus cisplatin (50mg/m2) or paclitaxel (175mg/m2) plus carboplatin(AUC of 6). The primary endpoint is overall survival (OS). Secondary endpoints are disease free survival (DFS), adverse events and QOL. This study began in November 2019 and a total of 290 patients will be accrued within 5 years. The study is coordinated by of the JGOG cervical cancer committee. Clinical trial information: 041190042.