Randomized Phase III Study in EBV Positive Locally Advanced Nasopharyngeal Carcinoma Treated With Concurrent Chemo-radiotherapy With or Without Anti-Viral Drug
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.
研究概览
简要总结
PCR-DNA of EBV test is a good prognostic indicator for survival after treatment (report: Prognostic Impact of Plasma, Epstein-Barr Virus DNA in Patients with Nasopharyngeal Carcinoma Treated using Intensity-Modulated Radiation Therapy.
The chances of the local recurrence or metastasis are higher in the patients at same stage with positive PCR-DNA of EBV in Nasopharyngeal carcinoma after same treatment.(ref.) Antiviral drugs have been used to inhibit EBV replication and target viral DNA polymerase are Foscarnet and phosphonoacetic acid both interact directly with the pyrophosphate-binding site of the enzyme, where Acyclovir as antiviral drug act at two levels: as competitive alternative substrates, competing with GTP on the substrate-binding site, and as DNA chain terminators, by incorporating into the growing DNA chain and blocking its elongation due to their acyclic structure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed histopathologic diagnosis of nasopharyngeal squamous cell carcinoma, types WHO II-III.
- •Stage II-IVB
- •Requiring primary concomitant Radiotherapy and Chemotherapy.
- •No head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies.
- •Positive PCR-DNA EBV
- •≥ 18 years of age
- •ECOG performance status 0-1
- •WBC ≥ 4,000/µl, platelets ≥ 100,000/µl; serum creatinine ≤ 1.6 mg/dl or 24 hr. calculated creatinine clearance ≥ 60 ml/min (see Section 3.1.6).
- •Pre-treatment evaluation of tumor extent and tumor measurement.
- •Nutritional and general physical condition must be considered compatible with the proposed radio-therapeutic treatment.
- •Signed study-specific consent form prior to study entry Assessment.
排除标准
- •Prior radiotherapy to the head and neck or any prior chemotherapy ≤ 6 months prior to study entry.
- •Other malignancy except non-melanoma skin cancer or a carcinoma not of head and neck origin ≤ 5 years
- •Evidence of distant metastasis.
- •on any experimental therapeutic cancer treatment.
- •major medical or psychiatric illness.
- •pregnant females.
- •Age ≤ 18 years old
研究组 & 干预措施
Antiviral Drug with Chemoradiotherapy
Antiviral therapy Acyclovir 800 mg per day during the whole course of treatment.
干预措施: Acyclovir 800 MG (Drug)
Antiviral Drug with Chemoradiotherapy
Antiviral therapy Acyclovir 800 mg per day during the whole course of treatment.
干预措施: Radiotherapy and chemotherapy (Combination Product)
Chemoradiotherapy
Patients will receive concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.
干预措施: Radiotherapy and chemotherapy (Combination Product)
结局指标
主要结局
Number of participants with Eliminated EBV titre as assessed by quantitative PCR-DNA in patients with NPC.
时间窗: 3 months
次要结局
未报告次要终点
研究者
Khaled Alsaleh,MD
Chairman, Radiation Oncology Department
Kuwait Cancer Control Center