Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer

Официальное название

Para-aortic Prophylactic Irradiation for Locally Advanced Cervical Cancer: a Prospective, Randomized, Multicenter Study

Обзор

Para-aortic lymph node metastasis is a poor prognostic factor for locally advanced cervical cancer, but false negative diagnosis is easy to occur. The aim of this trial was to investigate whether para-aortic prophylactic radiotherapy improves disease-free survival in patients with positive pelvic lymph nodes below the common iliac artery.

Подробное описание

This clinical trial enrolled participants with locally advanced cervical cancer with positive pelvic lymph nodes below the common iliac region diagnosed by Positron emission tomography-computed tomography(PET-CT). Participants should be able to receive concurrent cisplatin chemotherapy. No anti-tumor treatment was given before randomization. Participants will be randomly assigned to two groups. The study group will receive radiotherapy of pelvic and para-aorta, concurrent chemotherapy and brachytherapy, and the control group will receive pelvic radiotherapy, concurrent chemotherapy and brachytherapy.

Вмешательства

• Лучевая терапия Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation
  The para-aortic area, from left renal vein level to abdominal aorta bifurcation level，will be prophylactic irradiation. The other intervention is the same as control arm.
• Лучевая терапия Pelvic definitive concurrent chemoradiation
  Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.

Первичные конечные точки

• Progression-free survival rate [Срок оценки: 3-year]

Вторичные конечные точки (6)

• Overall survival rate [Срок оценки: 3-year]
• Para-aortic recurrence rate [Срок оценки: 3-year]
• Distant recurrence rate [Срок оценки: 3-years]
• Side effects [Срок оценки: 3-year]
• Quality of life (QOL) assessed by EORTC QLQ-C30 v3 [Срок оценки: 1-month and 6-month]
• Quality of life (QOL) assessed by EORTC QLQ-CX24 [Срок оценки: 1-month and 6-month]

Критерии участия

Критерии включения

• The patients voluntarily participated in the study and signed the informed consent
• 18-75 female
• Cervical squamous cell carcinoma / adenocarcinoma / adenosquamous cell carcinoma
• According to International Federation of Gynecology and Obstetrics(FIGO) 2009 stage, stage ⅠB2 - ⅣA with positive pelvic lymph nodes and negative common iliac and paraaortic lymph nodes diagnosed by PET-CT
• Cisplatin chemotherapy is acceptable
• Eastern Cooperative Oncology Group(ECOG) score 0-1
• The expected survival was more than 6 months
• Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and they are willing to use appropriate contraceptive methods during the test
• According to the judgment of the researcher, those who can comply with the trial protocol

Критерии исключения

• Uncontrolled severe infection
• Combined with other malignant tumor patients who need treatment and / or new diagnosis within 5 years
• The patient has received anti-tumor treatment
• Liver cirrhosis, decompensated liver disease, chronic renal insufficiency and renal failure
• History of immunodeficiency, including HIV positive or other acquired congenital immunodeficiency disease
• Myocardial infarction, severe arrhythmia and grade 2 or more congestive heart failure (NYHA classification)
• Patients with previous pelvic artery embolization
• Previous radiotherapy for pelvic malignant tumor
• There was a history of severe allergic reaction to platinum containing chemotherapy drugs
• Complications, need to be taken during the treatment of liver and kidney function damage drugs, such as tuberculosis
• The patients who could not understand the content of the experiment and could not cooperate and refused to sign the informed consent
• Patients with accompanying diseases or other special circumstances that seriously endanger the safety of patients or affect the completion of the study

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 · 7 центров

• Zhejiang Cancer Hospital — Ханчжоу
• The First Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу
• Jinhua Municipal Central Hospital Medical Group — Jinhua
• Lishui People's Hospital — Lishui
• Ningbo First Hospital — Ningbo
• Taizhou Central Hospiatl — Taizhou
• Chongqing University Three Gorges Hospital — Wanzhou

Идентификаторы

NCT: NCT04974346 · CARTOnG 2101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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