Clinical trial NCT01536223: Efficacy Study of Neoadjuvant Chemotherapy With Chemoradiation Therapy for Nasopharyngeal Carcinoma
Official title: Cisplatin and 5-fluorouracil(PF) or Docetaxel,Cisplatin and 5-fluorouracil (TPF) Neoadjuvant Chemotherapy With Chemoradiation Therapy for Locally Advanced Nasopharyngeal Carcinoma--A Randomised Prospective Multicenter Phase 3 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chemoradiation
Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma (NPC)
cisplatin and 5-fluorouracil (PF)
docetaxel,cisplatin and 5-fluorouracil(TPF)
Neoadjuvant Chemotherapy
intensity modulated radiotherapy(IMRT)
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Zhejiang University
name: Zhejiang Provincial People's Hospital
name: Sir Run Run Shaw Hospital
name: Wenzhou Medical University
First posted: 2012-02-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb) will receive either cisplatin plus 5-fluorouracil (PF) or docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy with concurrent chemoradiation.

Detailed description: For locally advanced nasopharyngeal carcinoma patients(UICC7th stageIII to IVb),the investigators randomised assign to either 3 cycles of cisplatin plus 5-fluorouracil plus (PF) or 3 cycles of docetaxel plus cisplatin and 5-fluorouracil(TPF) neoadjuvant chemotherapy. 21 days a cycle.

After the neoadjuvant chemotherapy ,the patients will receive the intensity modulated radiotherapy(IMRT) with 2 cycles of concurrent chemotherapy of cisplatin 80mg/m2.

Eligibility criteria: Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing carcinoma.
2. Tumor staged as N2-3 or T3-4N1(according to the 7th AJCC staging system)
3. No evidence of distant metastasis(M0)
4. Performance status:KPS\>70
5. With normal liver function test(ALT, AST\<1.5ULN)
6. Renal:creatinine clearance \>60ml/min
7. Without hematopathy,marrow:WBC\>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L.
8. With controled blood glucose for diabetes patients
9. Written informed consent

Exclusion Criteria:

1. WHO type I squamous cell carcinoma or adenocarcinoma
2. Age\>70 or \<18
3. With a history of renal disease
4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin0
5. Previous chemotherapy or radiotherapy(except non-melanomatous skin cancers outside the intended RT treatment volume)
6. Patient is pregnant or lactating .
7. Peripheral neuropathy
8. Emotional disturbance

Primary outcomes:
measure: 3-year progress free survival(PFS)
timeFrame: 3 years after the inception assignment
Secondary outcomes:
measure: overall survival(OS)
timeFrame: 2 years ,3 years and 5 years after the inception of the assignment
measure: Adverse events
timeFrame: participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years
measure: local control rate (LCR)
timeFrame: 1 year ,2 years,3 years and 5 years after the inception of the study
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiaozhong Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jin T, Qin WF, Jiang F, Jin QF, Wei QC, Jia YS, Sun XN, Li WF, Chen XZ. Cisplatin and Fluorouracil Induction Chemotherapy With or Without Docetaxel in Locoregionally Advanced Nasopharyngeal Carcinoma. Transl Oncol. 2019 Apr;12(4):633-639. doi: 10.1016/j.tranon.2019.01.002. Epub 2019 Feb 20.