Brief Title
TPF+CCRT vs.CCRT+PF in High Risk Nasopharyngeal Carcinoma
Official Title
Phase Ⅲ Trial of Induction Chemotherapy（TPF） Followed by Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Followed by Adjuvant Chemotherapy (PF) in Patients With High Risk Nasopharyngeal Carcinoma
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 nasopharyngeal carcinoma (NPC).
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 chemotherapy plus concurrent chemoradiotherapy
(investigational arm) or concurrent chemoradiotherapy plus PF (cisplatin+5-fluorouracil)
adjuvant chemotherapy (control arm). Patients in both arms receive intensity-modulated
radiotherapy(IMRT), and cisplatin (100mg/m2) every three weeks for three cycles during
radiotherapy. Patients in the investigational arm receive paclitaxel liposome (135mg/m2 on
day 1), cisplatin (25mg/m2 on day 1-3) and 5-fluorouracil (750mg/m2 civ 120h) every three
weeks for three cycles before the radiotherapy. Patients in the control arm receive adjuvant
cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every four weeks for
three cycles after the radiotherapy. The primary end point is progress-free survival (PFS).
Secondary end points include overall survival(OS),locoregional failure-free survival(LRRFS),
distant metastasis-free survival(DMFS), overall response rates after treatments and toxic
effects(short-term and long-term). All efficacy analyses are conducted in the
intention-to-treat population.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progress-free survival(PFS)
Secondary Outcome
Overall survival(OS)
Condition
Nasopharyngeal Carcinoma
Intervention
TPF+CCRT
Study Arms / Comparison Groups
TPF+CCRT
Description: Patients receive induction chemotherapy with paclitaxel liposome (135mg/m2 on day 1) ,cisplatin (25mg/m2 on day 1-3) and 5-fluorouracil (750mg/m2 civ 120h) every three weeks for three cycles before radiotherapy, then followed by concurrent IMRT and cisplatin (100mg/m2) concurrent every three weeks during radiotherapy (D1,D22,D43 of RT) .
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
322
Start Date
November 13, 2017
Completion Date
November 9, 2023
Primary Completion Date
November 9, 2020
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Gender
All
Ages
18 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Hai-Qiang Mai, MD,PhD, +862087343643, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03306121
Organization ID
2017-FXY-034
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Study Sponsor
Hai-Qiang Mai, MD,PhD, Study Chair, Sun Yat-sen Universitty Cancer Center
Verification Date
July 2019