A Randomized Clinical Trial Comparing Laparoscopic or Robot-assisted Radical/Simple Hysterectomy Versus Abdominal Radical/Simple Hysterectomy in Patients With Early-stage Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 756
- 试验地点
- 28
- 主要终点
- Disease-free survival
研究概览
简要总结
The G-LACC trial is a prospective, interventional, multicenter, open-label, randomized and controlled non-inferiority operative trial.
The main goal of this clinical trial is to evaluate the non-inferiority of minimally invasive radical hysterectomy in contrast to abdominal radical hysterectomy in patients with early-stage cervical cancer. In the case of SHAPE criteria, surgery may also be performed as minimally invasive or abdominal simple hysterectomy. The primary criterion for assessment is disease-free survival (DFS). As secondary outcomes, overall survival (OS), disease recurrence, quality of life, intra-/postoperative complications, and serious adverse events are recorded for assessment.
详细描述
Eligible patients will be randomly allocated to both treatment arms in a 1:1 ratio. Within an accrual period of 4 years, 378 patients will be included per arm (756 in total) across all sites. The Follow-up period after surgery will take a minimum of 5 years.
In the standard arm, radical hysterectomy is performed as per standard technique abdominal radical hysterectomy (Piver type 2 or 3 or Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Surgery includes pelvic lymph node dissection or optional sentinel lymph node biopsy (SNB) according to current guidelines in both arms.
In the experimental arm, radical hysterectomy is performed as per standard conventional 2D/3D laparoscopic or robotic assisted technique (Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. The following protective measures are mandatory for the minimally invasive arm: LEEP/conization prior to randomization or vaginal closure prior to colpotomy. Transcervical manipulators are not permitted. Use of uterus manipulators/ cervical adapter (without transcervical device) is allowed only after LEEP/conization. Meticulous dissection of pelvic (sentinel) lymph nodes including use of endobags and avoiding the dissemination of cancer cells will be implemented (tumor hygiene).
Due to the positive results of the SHAPE trial published at Plante et al. NEJM 2024, in both arms simple hysterectomy can be considered for patients with low-risk early-stage cervical cancer (SHAPE criteria: tumor < 2 cm, < 10 mm depth of stromal invasion (LEEP/cone) BUT has to be determined BEFORE randomization. Simple hysterectomy has to be performed as extrafascial hysterectomy and the preparation of a max. 5 mm vaginal cuff is required to ensure negative margins. Surgery can be performed including removal of the sentinel lymph nodes following the concept of sentinel lymph node biopsy (SNB) and according to the current guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix
- •Patients with FIGO stage IA2, IB1, or IB2 disease (<4 cm)
- •Patients undergoing radical hysterectomy according either to Type II or III (Piver Classification) or to Type B or C (Querleu and Morrow classification)
- •Simple hysterectomy can be considered for patients with low-risk early-stage cervical cancer (SHAPE criteria: tumor < 2cm, < 10 mm depth of stromal invasion (LEEP/cone). Simple hysterectomy has to be performed as extrafascial hysterectomy and the preparation of a max. 5mm vaginal cuff is required to ensure negative margins.
- •Performance status of ECOG 0-1
- •Patient must be suitable candidates for surgery with preoperative MRI and available for assessment of serious adverse events up to one year post-surgery
- •Patients who have signed an approved Informed Consent
- •Patients with a prior malignancy only if > 5 years previous with no evidence of disease
- •Females, aged 18 years or older
排除标准
- •Any histology other than an adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the uterine cervix
- •Tumor size of 4 cm and greater, estimated by either magnetic resonance imaging (MRI) or clinical examination
- •FIGO stage IB3 - IV
- •Patients with a history of pelvic or abdominal radiotherapy
- •Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes > 2 cm, or histologically positive lymph nodes
- •Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- •Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
- •Patient compliance and geographic proximity that do not allow adequate follow-up
- •Women who are pregnant
- •Patients with contraindications to surgery
- •Patients with secondary invasive neoplasm in the last 5 years (except non-melanoma skin cancer, breast cancer T1 N0 M0 grade 1 or 2 without any signs of recurrence or activity)
结局指标
主要结局
Disease-free survival
时间窗: up to year 5
Disease-free survival (DFS) is defined as the time from randomization to disease recurrence or death from any course (whichever occurs first). The date of disease recurrence is defined as the date of biopsy.
次要结局
- Overall survival(up to year 5)
- Disease recurrence(up to year 5 starting 6 months post-surgery)
- Health Related Quality of Life (HRQoL): Core questionnaire(up to year 5)
- Health Related Quality of Life (HRQoL): Cervical cancer questionnaire(up to year 5)
- Health Related Quality of Life (HRQoL): General health status(up to year 5)
- Health Related Quality of Life (HRQoL): Sexual activity(up to year 5)
- Lymphatic side effects: Investigator assessment(up to year 5)
- Lymphatic side effects: Patient assessment(up to year 5)
- Complications and treatment-associated morbidity(up to one year after surgery)
- Serious adverse events(up to one year after surgery)
- Health care costs: Cost-effectiveness(up to year 5)
- Health care costs: Direct cost assessment(up to year 5)
- Health care costs: Cost-utility analysis(up to year 5)
研究者
Peter Hillemanns
Prof. Dr. med., Director Department of Gynecology and Obstetrics
Hannover Medical School