Nedaplatin Versus Cisplatin and Capecitabine Versus Fluorouracil in IC + CCRT for Locoregionally Advanced NPC
- Conditions
- Nasopharyngeal Carcinoma
- Interventions
- Drug: docetaxel, nedaplatin, and capecitabine
- Registration Number
- NCT03503136
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 632
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description A (TPF+P-RT) docetaxel, cisplatin, and fluorouracil Induction docetaxel, cisplatin, and fluorouracil plus concurrent chemoradiotherapy with cisplatin A (TPF+P-RT) cisplatin Induction docetaxel, cisplatin, and fluorouracil plus concurrent chemoradiotherapy with cisplatin B (TNF+N-RT) nedaplatin Induction docetaxel, nedaplatin, and fluorouracil plus concurrent chemoradiotherapy with nedaplatin C (TPX+P-RT) cisplatin Induction docetaxel, cisplatin, and capecitabine plus concurrent chemoradiotherapy with cisplatin C (TPX+P-RT) docetaxel, cisplatin, and capecitabine Induction docetaxel, cisplatin, and capecitabine plus concurrent chemoradiotherapy with cisplatin D (TNX+N-RT) docetaxel, nedaplatin, and capecitabine Induction docetaxel, nedaplatin, and capecitabine plus concurrent chemoradiotherapy with nedaplatin D (TNX+N-RT) nedaplatin Induction docetaxel, nedaplatin, and capecitabine plus concurrent chemoradiotherapy with nedaplatin B (TNF+N-RT) docetaxel, nedaplatin, and fluorouracil Induction docetaxel, nedaplatin, and fluorouracil plus concurrent chemoradiotherapy with nedaplatin
- Primary Outcome Measures
Name Time Method Progression-free survival 3 years Progression-free survival is calculated from the date of randomisation to the date of disease progression or death from any cause, whichever is first.
- Secondary Outcome Measures
Name Time Method Overall survival 3 years Overall survival is calculated from randomization to death from any cause.
Distant failure-free survival 3 years Distant failure-free survival 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.
Locoregional failure-free survival 3 years Locoregional failure-free survival 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.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (acute toxicity) and RTOG/EORTC (late toxicity) Up to 3 years Incidence of acute and late toxicity
Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-C30 Up to 16 weeks QOL was assessed by EORTC QLQ-C30 during the treatment period
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China