Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)

Официальное название

A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)

Обзор

The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB1, IB2, IIA1).

Подробное описание

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB1, IB2, IIA1), by a multicenter stratified randomized controlled study, mainly including the following aspects:

1. To compare the differences in PFS and OS between patients receiving LRH and ARH. 2. To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes). 3. To assess postoperative complications and quality of survival.

Вмешательства

• Другое Total Laparoscopic or Robotic Radical Hysterectomy
  Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.
• Другое Total Abdominal Radical Hysterectomy
  Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.

Первичные конечные точки

• the rate of PFS at 5 years [Срок оценки: 5 years from surgery]

Вторичные конечные точки (1)

• the rate of OS at 5 years [Срок оценки: 5 years from surgery]

Критерии участия

Критерии включения

• Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB1,IB2,IIA1).
• Age ≥ 21 years and ≤ 70 years.
• Surgery type B and C (refer to Q-M surgical staging)
• Normal range of liver and kidney function and blood count (specific details below) Hemoglobin > 60g/L Platelets > 70\*109/L Leukocytes > 3\*109/L Creatinine < 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value.
• No history of other malignancies.
• Non-pregnancy.
• Physical strength classification: Karnofsky score ≥ 60;
• Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.
• No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI)

Критерии исключения

• Those who are contraindicated for various surgeries and cannot undergo surgery.
• Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.
• Patients with recurrent cervical cancer
• Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter >2cm after further improvement of preoperative examination.

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

• The Obstetrics and Gynecology Hospital of Fudan University — Шанхай

Публикации

• Wu X, Qiu L, Lou W, Wang X, Zhu T, Zhang Y, Hu W, Xue X, Zhu Z, Xiang L, Li J, Fang X, Gao S, Feng H, Diao W, Zhang H, Du M, Bai Y, Hou Y, Yan W, Feng H, Yu H, Zhu S, Du Y, Jiang H. A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial. PMID 35395868

Идентификаторы

NCT: NCT04929769 · FUOBGY2021-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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