Survival Effect of Hepato-celiac Lymphadenectomy In Primary or Relapsed Ovarian Cancer

Официальное название

A Prospective, Multi-center, Single-Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Hepato-celiac Lymphadenectomy in the Treatment of Advanced and Recurrent Ovarian Cancer

Обзор

The purpose of this study is to evaluate the safety and the effectiveness of hepato-celiac lymphadenectomy in the treatment of primarily diagnosed advanced epithelial ovarian cancer and platinum-sensitive recurrent ovarian cancer.

Подробное описание

This single-arm, multi-center, phase II trial is to evaluate the safety and effectiveness of hepato-celiac lymphadenectomy in the treatment of ovarian cancer with hepato-celiac lymph nodes metastases, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy).

Вмешательства

• Процедура Hepato-celiac lymphadenectomy
  Hepato-celiac lymphadenectomy in the treatment of epithelial ovarian cancer, with a maximum cytoreduction, in the circumstance of primarily diagnosed advanced epithelial ovarian cancer (primary debulking surgery or interval debulking surgery) and of platinum-sensitive recurrent ovarian cancer (no more than 4 lines of therapy).

Первичные конечные точки

• 2-years Non-Progression Rate [Срок оценки: Participants will be followed up to 2 years after randomization]

Вторичные конечные точки (8)

• Progression free survival [Срок оценки: Participants will be followed up to 24 months after randomization]
• Overall survival [Срок оценки: Participants will be followed up to 60 months after randomization]
• Objective response rate [Срок оценки: Participants will be followed up to 24 months after randomization]
• Disease control rate [Срок оценки: Participants will be followed up to 24 months after randomization]
• Post-operative complications [Срок оценки: Participants will be followed up to 90 days after randomization]
• Quality of life assessments (QLQ-C30) [Срок оценки: Baseline; 6 months, 12 months and 24 months after randomization]
• Quality of life assessments (FACT-Q) [Срок оценки: Baseline; 6 months, 12 months and 24 months after randomization]
• Patterns of subsequent recurrence [Срок оценки: Participants will be followed up to 24 months after randomization]

Критерии участия

Критерии включения

• Age ≥18 years to ≤ 75 years.
• Pathologic confirmed stage III or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (EOC, PPC, FTC) or platinum sensitive, relapsed EOC, PPC or FTC (no more than 4 lines of therapy)
• Hepato-celiac lymph nodes metastases diagnosed by imaging before surgery and enlarged palpable lymph nodes by surgical findings
• Assessed by the experienced surgeons, complete resection is feasible according to preoperative evaluation
• 1 to 3 episodes of neoadjuvant chemotherapy is allowed in primary settings
• Platinum sensitive relapse is defined as those with platinum-free interval of 6 months or more.
• ASA score of 1 to 2
• ECOG performance status of 0 to 2
• Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
• White blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
• Serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockcroft-Gault formula or to local lab measurement
• Serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL
• Comply with the study protocol and follow-up.
• Written informed consent.

Критерии исключения

• Patients with non-epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.
• Low-grade carcinoma.
• Mucinous ovarian cancer.
• Infeasible complete resection according to preoperative evaluation
• Unresectable pulmonary and hepatic parenchymal metastases, multiple thoracic lymph nodes metastases, brain or bone metastases according to preoperative evaluation.
• Carcinomatosis on small bowel mesentery or intestinal wall by surgical findings and infeasible optimal surgery by bowel resection or peritonectomy.
• Progression after neoadjuvant chemotherapy in primary settings.
• Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast cancer (without any signs of relapse or activity).
• Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
• Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT05236686 · zsfud-GynOncol-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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