Brief Title
Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in IC + CCRT for Locoregionally Advanced NPC
Official Title
Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in Induction Chemotherapy Plus Concurrent Chemoradiotherapy for Locoregionally Advanced NPC： a Phase 3, Multicentre, Non-inferiority, Randomised Factorial Trial
Brief Summary
This is a phase 3, multicentre, non-inferiority, randomised factorial trial. The purpose of
this study is to study the efficacy and safety of nedaplatin versus cisplatin, and
capecitabine versus fluorouracil in induction docetaxel, cisplatin, and fluorouracil (TPF)
plus concurrent chemoradiotherapy with cisplatin (P-RT) in locoregionally advanced
nasopharyngeal carcinoma (NPC).
Detailed Description
In this study, patients with non-keratinizing NPC and staged III-IVA (except T3-4N0) are
randomly assigned to one of the four groups: Group A: TPF+P-RT; Group B: TNF+N-RT; Group C:
TPX+P-RT; Group D: TNX+N-RT. In induction chemotherapy, patients will receive docetaxel(60
mg/m2 on day 1), cisplatin or nedaplatin (60 mg/m2 on day 1) and fluorouracil (600 mg/m2 on
Days 1 to 5) or capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three
cycles before the radical radiotherapy. Concurrent cisplatin or nedaplatin (100mg/m2 on day
1) was given every three weeks for two cycles during radiotherapy. Patients are stratified
according to the treatment centers and stage. The primary endpoint is progression-free
survival (PFS). Secondary end points include overall survival (OS), distant failure-free
survival (D-FFS), locoregional failure-free survival (LR-FFS), toxic effects, and quality of
life (QOL). All efficacy analyses are conducted in the intention-to-treat population, and the
safety population include only patients who receive their randomly assigned treatment.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Progression-free survival
Secondary Outcome
Overall survival
Condition
Nasopharyngeal Carcinoma
Intervention
docetaxel, nedaplatin, and capecitabine
Study Arms / Comparison Groups
A (TPF+P-RT)
Description: Induction docetaxel, cisplatin, and fluorouracil plus concurrent chemoradiotherapy with cisplatin
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
632
Start Date
June 2018
Completion Date
June 2026
Primary Completion Date
June 2024
Eligibility Criteria
Inclusion Criteria:
- Age 18-60
- Patients with newly histologically confirmed non-keratinizing (according to World
Health Organization (WHO) histologically type)
- Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0 or 1
- Tumor staged as American Joint Committee on Cance (AJCC) III-IVA (except T3-4N0)
- Adequate marrow: leucocyte count ≥ 4×10^9/L, hemoglobin ≥ 90g/L and platelet count ≥
100×10^9/L.
- Normal liver and renal 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; 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.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in
situ cervical cancer.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and
emphasize effective contraception during the treatment period).
- History of previous RT (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.
- Patients who could not tolerate or allergic to capecitabine.
- Illness that would interfere with oral medication, including dysphagia, chronic
diarrhea, or ileus.
Gender
All
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Principal Investigator Principal Investigator, M.D., +86-20-87343469, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03503136
Organization ID
2018-FXY-076
Responsible Party
Principal Investigator
Study Sponsor
Sun Yat-sen University
Collaborators
Tongji Hospital
Study Sponsor
Principal Investigator Principal Investigator, M.D., Principal Investigator, Sun Yat-sen University
Verification Date
May 2018