Radiotherapy Alone Versus Concurrent Chemo-radiotherapy for Nasopharyngeal Carcincoma Patients With Undectable EBV DNA After One Cylce Neoadjuvant Chemotherpy

Официальное название

A Multicenter, Randomized, Non-inferior Phase III Study of Radiotherapy Alone Versus Concurrent Chemo-radiotherapy in Locally Advanced Nasopharyngeal Carcinoma Patients With Complete Remission of EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy

Обзор

The goal of this multicenter randomized non-inferior study is to compare radiotherapy alone versus concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA drop to undetectable level after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: the omission of concurrent chemotherapy is safe in the relatively good prognostic patients identified by the response of EBV DNA. Participants will be randomized to either radiotherapy alone or the standard treatment concurrent chemoradiotherapy if their EBV DNA decrease to undetectable level post first cycle of neoadjuvant chemotherapy and don't rebound in the second and third cycle.

Вмешательства

• Препарат Radiotherapy
  IMRT for primary and regional field
• Препарат Cisplatin
  Cisplatin 80mg/m2, 21days/cycle, 2 cycles

Первичные конечные точки

• Progression-free survival [Срок оценки: 2 years]

Вторичные конечные точки (3)

• Overall survival [Срок оценки: 2 years]
• Toxicities [Срок оценки: 2 years]
• change of quality of life [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III.
• Age 18-70 years.
• Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer\[AJCC\] edition).
• Patients with detectable pre-treatment plasma EBV DNA but undetectable EBV DNA after one cycle neoadjuvant and no EBV DNA rebound during the second and third cycle.
• ECOG (Eastern Cooperative Oncology Group) score: 0-1
• Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
• Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)< 1.5 times the upper limit of normal value (ULN), total bilirubin <1.0×ULN.
• Renal function: serum creatinine <1×ULN.
• Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.

Критерии исключения

• Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
• Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
• Receiving radiotherapy or chemotherapy or targeted therapy previously
• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
• Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
• Severe, uncontrolled medical conditions and infections.
• At the same time using other test drugs or in other clinical trials.
• Refusal or inability to sign informed consent to participate in the trial.
• Emotional disturbance or mental illness, no civil capacity or limited capacity for civil conduct

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

• Fudan Universtiy Shanghai Cancer Centre — Шанхай

Идентификаторы

NCT: NCT05674305 · 20122229-15

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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