Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma After Concomitant Radiotherapy And Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 263
- 主要终点
- Distant-metastasis-free survival
研究概览
简要总结
This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.
详细描述
The standard treatment for stage II-III nasopharyngeal carcinoma is radiotherapy with concomitant chemotherapy and adjuvant chemotherapy. A subset of these patients has very low risk for distant metastasis that adjuvant chemotherapy is probably unnecessary. The investigators would like to know if same therapeutic effect and survival rate can be achieved without adjuvant chemotherapy, (i.e. less chemotherapy, same effect)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) biopsy-proven carcinoma of the nasopharynx,
- •(2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease,
- •(3) normal renal function (Cr < 1.6 mg/dl),
排除标准
- •open-neck lymph node biopsy
- •previous chemotherapy or radiotherapy to the head and neck region
- •distant metastasis or other malignant diseases except skin cancer
研究组 & 干预措施
CCRT alone
External beam radiotherapy > 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy
干预措施: Radiotherapy (Radiation)
CCRT alone
External beam radiotherapy > 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy
干预措施: Cisplatin (Drug)
CCRT alone
External beam radiotherapy > 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy
干预措施: 5-FU (Drug)
结局指标
主要结局
Distant-metastasis-free survival
时间窗: 5 years
percentage of patients who survived and has no distant metastasis
次要结局
- overall survival(5 years)
- disease-free survival(5 years)
研究者
Jia-Shing Wu
Attending Physician, M.D.
Sun Yat-sen University