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Through randomized controlled phase III multicenter clinical trials, TPF induction chemotherapy vs. PF regimen adjuvant chemotherapy concurrently Radiotherapy and chemotherapy for the treatment of locally advanced nasopharyngeal carcinoma: the efficacy, toxicity and quality of life, and further improvement Survival rate and improve the quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPF+CCRT | Experimental | TPF neoadjuvant chemotherapy followed by cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy |
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| CCRE+PF | Other | Cisplatin chemotherapy concurrent combined with intensity-modulated radiation therapy followed by PF adjuvant chemotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPF+CCRT | Drug | Patients receive Neoadjuvant Docetaxel (75mg/m2 on day1 03:30-04:30) and cisplatin (75mg/m2 on day 1-5 10:00-22:00) and 5-FU(750mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 10:00-22:00)every 21 days for three cycles during radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progress-free survival(PFS) | Progress-free survival(year) is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival(OS) | The OS(year) was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up. | 3 years |
| Locoregional failure-free survival(LRFS) |
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Inclusion Criteria:
Exclusion Criteria:
5.pregnancy (via the urine or serum β-HCG test confirmed) or during lactation. 6.serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Jin, Bachelor | Contact | 0851-86512802 | jinf8865@yeah.net | |
| Yuanyuan Li, Master | Contact | 0851-86512802 | lilyuanyuan@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuanyuan Li, Master | Guizhou Provincial Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | 550000 | China |
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| CCRT+PF | Drug | Patients receive concurrent cisplatin (100mg/m2 on day1 10:00-22:00)every 21 days for three cycles during radiotherapy followed by adjuvant cisplatin (80mg/m2 on day 1-5 10:00-22:00) and 5-FU(800mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles |
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The LRFS(year) is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit.
| 3 years |
| Distant metastasis-free survival(DMFS) | The DMFS(year) is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit. | 3 years |
| Overall response rate | Tumour response(CR/PR/SD/PD) was classified according to RECIST v1.1 | 12 weeks after completion of concurrent chemoradiotherapy |
| Incidence of acute and late toxicity | Incidence of acute toxicity（Grade1/2/3/4） is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme | 3 years |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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