Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal Carcinoma, Induction chemotherapy, Concurrent chemoradiotherapy, Nedaplatin, Capecitabine
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.
Interventions
DRUGdocetaxel, nedaplatin, and capecitabine
Patients receive docetaxel(60 mg/m2 on day 1), nedaplatin (60 mg/m2 on day 1) and capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radiotherapy.
DRUGnedaplatin
Patients receive concurrent nedaplatin (100mg/m2) every three weeks for two cycles during radiotherapy.
DRUGdocetaxel, cisplatin, and fluorouracil
Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
DRUGcisplatin
Patients receive concurrent cisplatin (100mg/m2) every three weeks for two cycles during radiotherapy.
DRUGdocetaxel, cisplatin, and capecitabine
Patients receive docetaxel(60 mg/m2 on day 1), cisplatin (60 mg/m2 on day 1) and capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radiotherapy.
DRUGdocetaxel, nedaplatin, and fluorouracil
Patients receive docetaxel (60mg/m2 on day 1), nedaplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
Sponsors
Tongji Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Peking University
Air Force Military Medical University, China
Second Affiliated Hospital of Soochow University
The First Affiliated Hospital of Guangdong Pharmaceutical University
First People's Hospital of Foshan
Fifth Affiliated Hospital, Sun Yat-Sen University
Cancer Hospital of Guizhou Province
Xiangya Hospital of Central South University
Jilin Provincial Tumor Hospital
Henan Cancer Hospital
Hunan Cancer Hospital
Cancer Hospital of Guangxi Medical University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Zhejiang Cancer Hospital
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactJun Ma, M.D.
Outcome results
None listed