German-funded Laparoscopic Approach to Cervical Cancer

Официальное название

A Randomized Clinical Trial Comparing Laparoscopic or Robot-assisted Radical/Simple Hysterectomy Versus Abdominal Radical/Simple Hysterectomy in Patients With Early-stage Cervical Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Laparoscopic or robot-assisted radical/simple hysterectomy
  In the experimental arm, patients with early-stage cervical cancer will be treated by using laparoscopic or robot-assisted radical, or in the case of SHAPE criteria, simple hysterectomy.
• Процедура Abdominal radical/simple hysterectomy
  In the control arm, patients with early-stage cervical cancer will be treated by using abdominal radical, or in the case of SHAPE criteria, simple hysterectomy as standard therapy.

Первичные конечные точки

• Disease-free survival [Срок оценки: up to year 5]

Вторичные конечные точки (12)

• Overall survival [Срок оценки: up to year 5]
• Disease recurrence [Срок оценки: up to year 5 starting 6 months post-surgery]
• Health Related Quality of Life (HRQoL): Core questionnaire [Срок оценки: up to year 5]
• Health Related Quality of Life (HRQoL): Cervical cancer questionnaire [Срок оценки: up to year 5]
• Health Related Quality of Life (HRQoL): General health status [Срок оценки: up to year 5]
• Health Related Quality of Life (HRQoL): Sexual activity [Срок оценки: up to year 5]
• Lymphatic side effects: Investigator assessment [Срок оценки: up to year 5]
• Lymphatic side effects: Patient assessment [Срок оценки: up to year 5]
• Complications and treatment-associated morbidity [Срок оценки: up to one year after surgery]
• Serious adverse events [Срок оценки: up to one year after surgery]
• Health care costs: Cost-effectiveness [Срок оценки: up to year 5]
• Health care costs: Direct cost assessment [Срок оценки: up to year 5]

Критерии участия

Критерии включения

• 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)

OR

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 14 центров

• Ludwigsburg Hospital, Department of Gynecology and Obstetrics — Ludwigsburg
• University Medical Center Tübingen, Department of Gynecology — Tübingen
• Hochtaunus-Clinics Bad Homburg, Department of Gynecology — Bad Homburg
• University Medical Center Göttingen, Department of Gynecology and Obstetrics — Göttingen
• Hannover Medical School, Department of Gynecology and Obstetrics — Hanover
• Hospital Lüneburg, Department of Gynecology — Lüneburg
• Hospital Bielefeld - Center, Department of Gynecology — Bielefeld
• University Medical Center Düsseldorf, Department of Gynecology and Obstetrics — Düsseldorf
• … и ещё 6 центров

Идентификаторы

NCT: NCT06489795 · G-LACC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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