Status:
ACTIVE_NOT_RECRUITING
TPF+CCRT vs.CCRT+PF in High Risk Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Nasopharyngeal Carcinoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
To see the effect of induction chemotherapy（TPF） followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by adjuvant chemotherapy (PF) in treating patients with high risk...
Detailed Description
Patients presented with non-keratinizing NPC and stage AnyTN2-3M0 and plasma EBV DNA≥1500copies/ml are randomly assigned to receive TPF(paclitaxel liposome+cisplatin+5-fluorouracil) induction chemothe...
Eligibility Criteria
Inclusion
- Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type).
- Original clinical staged as anyT N2-3M0（according to the American Joint Committee on Cancer(AJCC) 7th edition）and plasma EBVDNA≥1500copies/ml
- No evidence of distant metastasis (M0).
- Age 18-65 years old.
- ECOG Performance status less or equal to 1
- Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
- Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- Adequate renal function: creatinine clearance ≥60 ml/min.
- Patients must be informed of the investigational nature of this study and give written informed consent.
Exclusion
- WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Age \<18 or \>65years.
- Treatment with palliative intent.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation.
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.
Key Trial Info
Start Date :
November 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT03306121
Start Date
November 13 2017
End Date
December 31 2026
Last Update
May 22 2023
Active Locations (1)
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1
Sun Yat-sen Universitty Cancer Center
Guangzhou, Guangdong, China, 510060