Lymphadenectomy in Early Ovarian Cancer

Официальное название

A Prospective Randomized Multicentre Trial for Lymphadenectomy in Early-stage Ovarian Cancer

Обзор

To assess the impact of comprehensive staging surgery with no lymphadenectomy on survival and quality of life in patients with early-stage ovarian cancer.

Подробное описание

OBJECTIVES: Compare the efficacy and safety in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA -IIA epithelial ovarian cancer, undergo completion staging surgery including systematic pelvic and para-aortic lymphadenectomy versus comprehensive staging surgery without lymphadenectomy.

OUTLINE: This is a randomized phase III multicenter study. Patients will receive comprehensive staging surgery without Lymphadenectomy or completion staging surgery including systematic pelvic and para-aortic lymphadenectomy, and the adjuvant chemotherapy will accord to National Comprehensive Cancer Network (NCCN) guidelines. Patients are followed up every 3 months within the first 2 years, and then every 6 months.

PROJECTED ACCRUAL: A total of 656 patients will be recruited for this study within 5 years.

Вмешательства

• Процедура Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy
  * open or minimally invasive surgical approach * cytologic examinations * All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied * BSO and hysterectomy * For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered * Omentectomy * Para-aortic lymph node dissection should be performed by stripping the nodal tissue from the vena cava and the aorta bilaterally to at least th
• Процедура Comprehensive staging surgery with no Lymphadenectomy
  * open or minimally invasive surgical approach * cytologic examinations * All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied * BSO and hysterectomy * For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered * Omentectomy * In open approach surgery, exploring the pelvic and Para-aortic lymph node with hand. In minimally invasive surgery, the peritoneal above the pe

Первичные конечные точки

• PFS(Progression-free survival) [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]

Вторичные конечные точки (4)

• OS(Overall Survival) [Срок оценки: From date of randomization until the date of death from any cause or date of last follow up, up to 100 mons]
• Recurrence rate of lymph node [Срок оценки: 3 years]
• QoL(Quality of life) [Срок оценки: Baseline, 6 months and 1 year after surgery]
• Postoperative complications [Срок оценки: 3 years]

Критерии участия

Критерии включения

• Women aged 18 years to 70 years.
• Primary diagnosis of epithelial ovarian cancer FIGO stage IA-IIA ( recevive no prior treatment or receive incomplete initial surgery)，with indications of adjuvant chemotherapy：①High-grade serous carcinoma; ②Grade 3 endometrioid carcinoma; ③Clear cell carcinoma; ④Grade 2 endometrioid carcinoma with capsule ruptured or pelvic tissues extension ⑤Low-grade serous carcinoma、Grade 1 endometrioid carcinoma and Mucinous carcinoma of the ovary with pelvic tissues extension.
• Patients who have given their signed and written informed consent.
• Good performance status (ECOG 0/1).

Критерии исключения

• Non epithelial ovarian malignancies and borderline tumors.
• Suspicious lymph nodes at preoperative radiological evaluation.
• Intraoperative clinically suspicious lymph nodes (bulky nodes).
• Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity.
• Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy.
• Diseases of the lymph system (including lymph edema of unknown origin).
• Prior retroperitoneal lymph node dissection (systematic or sampling).
• Any other concurrent medical conditions contraindicating surgery.
• Pregnancy.
• Any reasons interfering with giving of informed consent , abiding by protocol, or regular follow-up.

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

Китай · 1 центр

• Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center — Гуанчжоу

Публикации

• Deng T, Liu K, Chen L, Chen X, Li HW, Guo H, Zhang H, Xiang L, Feng X, Wang X, Ngan HY, Zhao J, Zou D, Liu Q, Liu J. A prospective randomized multicenter trial for lymphadenectomy in early-stage ovarian cancer: LOVE study. J Gynecol Oncol. 2023 May;34(3):e52. doi: 10.3802/jgo.2023.34.e52. Epub 2023 Apr 10. PMID 37116952

Идентификаторы

NCT: NCT04710797 · 2020-FXY-405

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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