TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma

Официальное название

TPC Versus GP Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma, a Multi-center Phase II Randomized Trial

Обзор

The NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy as the standard treatment for locoregionally advanced nasopharyngeal carcinoma (NPC). However, meta-analyses have shown significant survival differences between different induction chemotherapy regimens. How to choose an induction chemotherapy regimen and treatment course that ensures definitive therapeutic effects and low incidence of toxic side effects remains a hot spot in clinical research. Polymeric micellar paclitaxel are an innovative form of paclitaxel drugs, with high penetration and long retention effects, which can enter the vascularly disordered tumor microenvironment through passive targeting and form higher concentrations in tumor tissue. It remains to be investigated whether the TPC (paclitaxel, cisplatin and capecitabine) regimen based on polymeric micellar paclitaxel compared to the current standard first-line induction chemotherapy GP (gemcitabine, cisplatin) regimen can further improve therapeutic effects in high-risk patients with locally advanced disease. There is still a lack of head-to-head studies for comparison. This study aims to compare, through a prospective, parallel-controlled, randomized, open-label, multicenter phase II clinical trial, the TPC induction chemotherapy vs. the GP induction chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk locoregionally advanced NPC (T4 or N2-3) in terms of 2-year progression-free survival, overall survival, overall response rate, toxic side effects, etc.

Вмешательства

• Препарат TPC induction chemotherapy
  TPC induction chemotherapy regimen contains Polymeric micellar paclitaxel, which is a novel Cremophor EL-free, nanoparticle micellar formulation of paclitaxel, cisplatin and capecitabine. TPC induction chemotherapy regimen (polymeric micellar paclitaxel 200 mg/m2 D1, cisplatin 75 mg/m2 D1, capecitabine 1000 mg/m2/day D1-14, every 3 weeks for 3 cycles).
• Препарат GP induction chemotherapy
  GP induction chemotherapy regimen (gemcitabine 1000 mg/m2 D1/8, cisplatin 80 mg/m2 D1, every 3 weeks for 3 cycles)

Первичные конечные точки

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

Вторичные конечные точки (5)

• Overall survival [Срок оценки: 2 years]
• Distant progression [Срок оценки: 2 years]
• Locoregional progression [Срок оценки: 2 years]
• Short-term response rate [Срок оценки: 32 weeks]
• Incidence of acute and late toxicity [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Age between 18 and 65 years;
• Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma (WHO type II or III);
• Staged as T4N0-3M0 or T1-4N2-3M0 (UICC 8th edition);
• Easte Cooperative Oncology Group performance status of 0 or 1;
• Adequate bone marrow: leucocyte count ≥ 4×109/L, hemoglobin ≥ 90g/L and platelet count ≥ 100×109/L;
• Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and AST or ALT ≤ 1.5 xULN;
• Adequate renal function: creatinine clearance rate ≥ 60 ml/min or creatinine ≤ 1.5× ULN;
• Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control throughout protocol treatment;
• Patients must be appraised of the investigational nature of the study and provide written informed consent.

Критерии исключения

• WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma;
• Treatment with palliative intent;
• Prior malignancy (except for adequately treated carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin);
• History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume);
• Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
• Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period);
• Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance;
• Prior allergic reaction to the study drug(s) involved in this protocol.

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 · 8 центров

• Sun Yat-sen University Cancer Center — Гуанчжоу
• Affiliated cancer hospital and institute of guangzhou medical university — Гуанчжоу
• Sun Yat-Sen Memorial Hospital — Гуанчжоу
• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• Dongguan people's hospital — Дунгуань
• Foshan First People's Hospital — Foshan
• Peking university shenzhen hospital — Шэньчжэнь
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT06301165 · 2023-FXY-129

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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