Clinical Efficacy of Adjuvant Chemotherapy in Patients With Locally Advanced Cervical Cancer Who Did Not Meet the NCCN Guidelines for Adjuvant Treatment After NACT Combined With Surgery

Обзор

This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients with FIGO stage IB3, Ⅱ A2 or IIB with tumor size\> 4 cm will be enrolled. Patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (NACT) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. Patients meet criteria of adjuvant therapy according to NCCN guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. The primary endpoint was disease-free survival (DFS) rate at 5 year. The secondary endpoints were 5-year overall survival (OS), safety and quality of life.

Вмешательства

• Препарат Adjuvant chemotherapy
  Drug: Paclitaxel or docetaxel + Cisplatin or carboplatin Paclitaxel 135-175mg/m2 over 3 hours or docetaxel 70-75 mg/m2， 30min ＋ Cisplatin 75-80mg/m2 or carboplatin AUC = 5, repeat per 21 days.

Первичные конечные точки

• Disease-free survival (DFS) [Срок оценки: 5 year]

Вторичные конечные точки (4)

• Overall survival （OS） [Срок оценки: 5 year]
• Quality of Life Outcomes [Срок оценки: 5 years]
• Quality of Life Outcomes of cervical cancer [Срок оценки: 5 years]
• Incidence of Toxicity [Срок оценки: 5 years]

Критерии участия

Критерии включения

• Clinical stage IB3-IIB cervical cancer (FIGO, 2018 standard) with the tumor diameter > 4cm before treatment.
• Pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma.
• Age：18-70 years old.
• ECOG status score ≤1;
• WBC≥3.5\*10\^9/L, NEU≥1.5\*10\^9/L, Platelet≥80×10\^9 /L; AST and ALT ≤1.5 times normal upper limit; Total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value.
• Well-compliance and willing to keep in touch.
• Able to sign informed consent, including complying with the requirements and restrictions listed in the Informed Consent (ICF) and this protocol.

Критерии исключения

• After 2-3 cycles of neoadjuvant chemotherapy, patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator.
• Neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens.
• Postoperative high risk factors: ① lymph node metastasis, ② parauterine infiltration, ③ positive surgical margin.
• Postoperative risk factors meet the Sedlis standard of the NCCN guideline.
• Participate in other clinical trials.
• Severe diseases of other important systems and organs.
• Persons without disposing capacity.
• Drug and/or alcohol abuse.
• Unable or unwilling to sign informed consents.
• Not eligible for the study judged by researchers.

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

• Tongji Hospital — Ухань

Идентификаторы

NCT: NCT04733820 · 2020-S111

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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