Randomized Trial to Evaluate Therapeutic Gain by Changing Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 803
- 试验地点
- 7
- 主要终点
- Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.
研究概览
简要总结
The objectives of this clinical study are threefold:
- To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation.
- To test whether replacing fluorouracil with Xeloda in combining with cisplatin in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay.
- To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.
详细描述
-
primary objectives include
-
comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF)
-
comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF)
-
comparing accelerated fractionation versus conventional fractionation (AF vs CF)radiotherapy.
-
secondary objectives include
-
comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P)
-
Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy sequence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically proven nasopharyngeal carcinoma for primary treatment with radical intent
- •non-keratinizing or undifferentiated type
- •stage III-IVB (by AJCC/UICC 6th edition)
- •ECOG Performance status less or equal to 2
- •Marrow: WBC >= 4 and platelet >=100
- •Renal: creatinine clearance >=60
- •Informed consent
排除标准
- •Primary treatment with palliative intent
- •WHO type I squamous cell carcinoma or adenocarcinoma
- •Evidence of distant metastases
- •Patient is pregnant or lactating
- •Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years
研究组 & 干预措施
1A
Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy
干预措施: Adjuvant chemotherapy using PF (5-Fluorouracil ) (Drug)
1B
Concurrent-Adjuvant CRT using P-PF regimen and accelerated fractionation radiotherapy
干预措施: Adjuvant chemotherapy using PF (5-Fluorouracil ) (Drug)
2A
Induction-Concurrent CRT using PF-P regimen and conventional fractionation radiotherapy
干预措施: Induction chemotherapy using PF (5-Fluorouracil) (Drug)
2B
Induction-Concurrent CRT using PF-P regimen and accelerated fractionation radiotherapy
干预措施: Induction chemotherapy using PF (5-Fluorouracil) (Drug)
3A
Induction-Concurrent CRT using PX-P regimen and conventional fractionation radiotherapy
干预措施: Capecitabine (Drug)
3B
Induction-Concurrent CRT using PX-P regimen and accelerated fractionation radiotherapy
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.
时间窗: 5 years
Overall Survival, defined as the time to death due to any cause, at 5-year.
时间窗: 5 years
次要结局
- Distant Failure-Free Rate, defined as time to distant failure)(5 years)
- overall Failure-Free Rate, defined as time to failure at any site)(5 years)
- Loco-regional Failure-Free Rate, defined as time to local or nodal failure)(5 years)
- Incidence of chemotherapy toxicity and acute RT toxicity grade > 3(treatment)
- Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3)(5 years)
研究者
Dr. ANNE W M LEE
Consultant, Dept of Clinical Oncology, PYNEH
Hong Kong Nasopharyngeal Cancer Study Group Limited