Induction Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma, Concurrent chemoradiotherapy, Induction chemotherapy, Clinical trial

Brief summary

The purpose of this study is to compare induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of induction chemotherapy in NPC patients.

Detailed description

Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive induction chemotherapy (docetaxel+cisplatin+fluorouracil) plus concurrent chemoradiotherapy (investigational arm) or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy, and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Patients in the investigational arm 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. Patients are stratified according to the treatment centers and stage. The primary end point is failure-free survival (FFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), initial response rates after treatments and toxic effects. All efficacy analyses are conducted in the intention-to-treat population; the safety population include only patients who receive their randomly assigned treatment.

Fangxing Zhu, Xinyu Zhou, Yiyi Zhang, Zhihang Zhou, Yingying Huang et al. (8 authors)

Cancers2024-07-30

10.3390/cancers16152707

Radiotherapy interruption due to holidays adversely affects the survival of patients with nasopharyngeal carcinoma: a joint analysis based on large-scale retrospective data and clinical trials

Cheng Xu, Kai‐Bin Yang, Ruijia Feng, Lei Chen, Xiaojing Du et al. (10 authors)

Radiation Oncology2022-02-1911 citations

10.1186/s13014-022-02006-5

Differential benefit of induction chemotherapy according to body mass index in nasopharyngeal carcinoma - Pooled analysis of two randomized trials.

Liu X, Li WF, Ding C, Chen L, Sun Y, Li JH, Ma J, Zhang Y.

2022-01-18

10.1016/j.oraloncology.2022.105718

Identifying optimal clinical trial candidates for locoregionally advanced nasopharyngeal carcinoma: Analysis of 9468 real-world cases and validation by two phase 3 multicentre, randomised controlled trial.

Tang SQ, Chen L, Li WF, Chan ATC, Huang SH, Chua MLK, O'Sullivan B, Lee AWM, Lee NY, Zhang Y, Chen YP, Xu C, Sun Y, Tang LL, Ma J.

2021-12-2819 citations

10.1016/j.radonc.2021.12.029

Selection and Validation of Induction Chemotherapy Beneficiaries Among Patients With T3N0, T3N1, T4N0 Nasopharyngeal Carcinoma Using Epstein-Barr Virus DNA: A Joint Analysis of Real-World and Clinical Trial Data

Cheng Xu, Shu Zhang, Wen-Fei Li, Lei Chen, Yan‐Ping Mao et al. (9 authors)

Frontiers in Oncology2019-11-2933 citations

10.3389/fonc.2019.01343

Development and validation of a novel MR imaging predictor of response to induction chemotherapy in locoregionally advanced nasopharyngeal cancer: a randomized controlled trial substudy (NCT01245959).

Dong D, Zhang F, Zhong LZ, Fang MJ, Huang CL, Yao JJ, Sun Y, Tian J, Ma J, Tang LL.

2019-10-2359 citations

10.1186/s12916-019-1422-6

Induction chemotherapy with paclitaxel liposome, nedaplatin, and fluorouracil in patients with locally advanced nasopharyngeal carcinoma: A phase II study.

Jing Yan, Ju Yang, Wei Ren, Kongcheng Wang, Bin Huang et al. (15 authors)

Journal of Clinical Oncology2018-05-201 citations

10.1200/jco.2018.36.15_suppl.e18024

Nomogram to predict the benefit of additional induction chemotherapy to concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: Analysis of a multicenter, phase III randomized trial.

Zhang Y, Li WF, Liu X, Chen L, Sun R, Sun Y, Liu Q, Ma J.

2017-12-1613 citations

10.1016/j.radonc.2017.12.002

Induction chemotherapy for locoregionally advanced nasopharyngeal carcinoma

Wen-Fei Li, Lei Chen, Ying Sun, Jun Ma

Chinese Journal of Cancer2016-11-1520 citations

10.1186/s40880-016-0157-4

Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial.

Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J.

2016-09-27684 citations

10.1016/s1470-2045(16)30410-7

Interventions

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.

RADIATIONConcurrent chemoradiotherapy

Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 59 Years

Healthy volunteers

No

Inclusion criteria

* Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type). * Tumor staged as T3-4N1/N2-3 (according to the 7th American Joint Commission on Cancer edition). * No evidence of distant metastasis (M0). * Satisfactory performance status: Karnofsky scale (KPS) \> 70. * 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 ≥60 years or \<18 years. * 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.

Design outcomes

Primary

Measure	Time frame	Description
Failure-free survival	3-year	Failure-free survival is calculated from the date of randomisation to the date of treatment failure or death from any cause, whichever is first.

Secondary

Measure	Time frame	Description
Overall survival	3-year	Overall survival is calculated from randomization to death from any cause.
Locoregional failure-free survival	3-year	The latency (ie, time from randomisation) to the first locoregional failure
Distant failure-free survival	3-year	The latency (ie, time from randomisation) to the first remote failure
The initial response rates after treatments	A week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy	—
Toxic effects	During and after treatment	—

Countries

China

Outcome results

None listed