Cibula David, Borčinová Martina, Kocian Roman, Feltl David, Argalacsova Sona, Dvorak Pavel, Fischerová Daniela, Dundr Pavel, Jarkovsky Jiri, Höschlová Eva, Slama Jiri, Scambia Giovanni
Gynaecologic Oncology Centre, First Faculty of Medicine, Charles University and General University Hospital in Prague, Prague, Czech Republic
Central and Eastern European Gynecologic Oncology Group (CEEGOG), Prague, Czech Republic.
Int J Gynecol Cancer. 2022 Oct 3;32(10):1327-1331. doi: 10.1136/ijgc-2022-003918.
The role of adjuvant treatment in the intermediate-risk group of patients with early-stage cervical cancer is controversial and is supported by a single randomized Gynecologic Oncology Group (GOG) 92 study performed more than 20 years ago. Recent retrospective studies have shown excellent local control in this group of patients after radical surgery with no additional adjuvant treatment.
To evaluate if adjuvant (chemo)radiation is associated with a survival benefit after radical surgery in patients with intermediate-risk cervical cancer.
Radical surgery alone is non-inferior to the combined treatment of radical surgery followed by adjuvant (chemo)radiation in disease-free survival in patients with intermediate-risk cervical cancer.
This is a phase III, international, multicenter, randomized, non-inferiority trial in which patients with intermediate-risk cervical cancer will be randomized 1:1 into arm A, with no additional treatment after radical surgery, and arm B, receiving adjuvant external beam radiotherapy±brachytherapy ± concomitant chemotherapy. Patient data will be collected over 3 years post-randomization of the last enrolled patient for primary endpoint analysis or for 6 years for the overall survival analysis.
MAJOR INCLUSION/EXCLUSION CRITERIA: Patients with intermediate-risk early-stage cervical cancer (IB1-IIA), defined as lymph node-negative patients with a combination of negative prognostic factors (tumor size >4 cm; tumor size >2 cm and lymphovascular space invasion; deep stromal invasion >2/3; or tumor-free distance <3 mm) with squamous cell carcinoma or human papillomavirus (HPV)-related adenocarcinoma, are eligible for the trial.
Disease-free survival defined as time from randomization to recurrence diagnosis.
514 patients from up to 90 sites will be randomized.
It is estimated that the accrual will be completed by 2027 (with 3 additional years of follow-up) and primary endpoint results will be published by 2031. Estimated trial completion is by 2034.
NCT04989647.
辅助治疗在早期宫颈癌中危组患者中的作用存在争议，仅由20多年前进行的一项妇科肿瘤学组（GOG）92随机研究提供支持。近期的回顾性研究表明，该组患者在根治性手术后无需额外辅助治疗即可实现良好的局部控制。
评估辅助（化疗）放疗是否能使中危宫颈癌患者在根治性手术后获得生存获益。
在中危宫颈癌患者的无病生存方面，单纯根治性手术不劣于根治性手术联合辅助（化疗）放疗的联合治疗。
这是一项III期国际多中心随机非劣效试验，中危宫颈癌患者将按1:1随机分为A组（根治性手术后不进行额外治疗）和B组（接受辅助外照射放疗±近距离放疗±同步化疗）。在最后一名入组患者随机分组后3年收集患者数据进行主要终点分析，或6年进行总生存分析。
主要纳入/排除标准：中危早期宫颈癌（IB1-IIA）患者，定义为淋巴结阴性且合并阴性预后因素（肿瘤大小>4 cm；肿瘤大小>2 cm且有脉管间隙浸润；深层间质浸润>2/3；或切缘距肿瘤<3 mm）的鳞状细胞癌或人乳头瘤病毒（HPV）相关腺癌患者符合试验条件。
无病生存，定义为从随机分组到复发诊断的时间。
来自多达90个地点的514例患者将被随机分组。
预计入组将于2027年完成（另有3年随访），主要终点结果将于2031年公布。预计试验于2034年完成。
NCT04989647。
