Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer

Официальное название

A Multicenter Randomized Controlled Study of Modalities of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer

Обзор

Endometrial cancer is the most common gynecological malignancy affecting women's health. About 15% of the patients will have local late disease (stage III) with high risk of recurrence and tumor related mortality. There is a consensus that adjuvant radiochemotherapy is needed for stage Ⅲ endometrial cancer, but the best modality of radiochemotherapy is still uncertain. The retrospective data of our center showed that the sequential radiochemotherapy of "chemotherapy-radiotherapy-chemotherapy" in the "sanwich" mode could improve the survival outcome in patients with advanced endometrial cancer. A multicenter, prospective, randomized controlled study to compare the "sanwich" mode of radiochemotherapy and the "concurrent chemoradiotherapy followed by chemotherapy" mode will be carried out to determine the better modality of radiochemotherapy in stage III endometrial adenocarcinoma.

Вмешательства

• Другое sequential radiochemotherapy in a "sanwich" mode
  Patients will randomized into two different modalities of radiochemotherapy.

Первичные конечные точки

• Progress-free survival [Срок оценки: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 60 months]

Вторичные конечные точки (3)

• Overall survival [Срок оценки: From the date of randomization until the date of death from any cause, assessed up to 60 months]
• adverse effect [Срок оценки: through study completion,an average of 1 year]
• patient-reported Quality of Life [Срок оценки: 3 months after treatment and 1 year after treatment]

Критерии участия

Критерии включения

• patients of primary treatment
• All patients must have undertaken comprehensive staging operation（Surgery must have included a hysterectomy and bilateral salpingooophorectomy and surgical staging).
• Patients with endometrial adenocarcinoma confirmed by postoperative patholog.
• All patients with Surgical Stage III endometrial carcinoma according to FIGO 2009 staging criteria.
• Entry into the study is limited to no more than 8 weeks from the date of surgery.
• Patients with adequate organ function, reflected by the following parameters:

• WBC ≥ Normal value of the institution;
• Absolute neutrophil count (ANC) ≥ Normal value of the institution;
• Platelet count ≥ 100,000/mcl;
• SGOT, SGPT, and alkaline phosphatase ≤ 1.25 X upper limit of normal (ULN) ;
• Bilirubin ≤ 1.5 X ULN;
• Creatinine ≤ institutional ULN.
• Patients with a Karnofsky score≥60.
• The patients should voluntarily join the study, sign an approved informed consent with good compliance and cooperation with the follow-up.

Критерии исключения

• Patients who have received prior adjuvant therapy (radiotherapy or chemotherapy or endocrine therapy).
• Patients with residual tumor after surgery.
• Patients with other invasive malignancies.
• Patients with contraindications of radiotherapy and chemotherapy (with a history of myocardial infarction within 3 month, unstable angina pectoris or history of uncontrolled arrhythmia s from the date of registration) and who cannot receive postoperative adjuvant radiotherapy and chemotherapy.
• Patients with an estimated survival of less than 6 months.
• Those who are unable or unwilling to comply with the research requirements

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

• Jianliu Wang — Пекин

Идентификаторы

NCT: NCT04453904 · 2020PHB013-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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