Adjuvant Chemotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma, Concurrent chemoradiotherapy, Adjuvant chemotherapy, Clinical trial

Brief summary

The purpose of this study is to compare concurrent chemoradiotherapy plus adjuvant chemotherapy with concurrent chemoradiotherapy in patients with locoregionally advanced NPC, in order to evaluate the value of adjuvant chemotherapy in nasopharyngeal carcinoma (NPC) patients.

Detailed description

Patients presented with non-keratinizing NPC and stage T3-4N1M0/TxN2-3M0 are randomly assigned to receive concurrent chemoradiotherapy plus adjuvant chemotherapy (investigational arm)or concurrent chemoradiotherapy (control arm). Patients in both arms receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy. Patients in the investigational arm receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy. Patients are stratified according to the treatment centers. The primary end point was failure-free survival (FFS). Secondary end points included overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), the initial response rates after treatments, toxic effects and treatment compliance. All efficacy analyses were conducted in the intention-to-treat population; the safety population included only patients who received their randomly assigned treatment.

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

Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial.

Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J.

2017-02-22110 citations

10.1016/j.ejca.2017.01.002

Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial.

Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J.

2011-12-07433 citations

10.1016/s1470-2045(11)70320-5

Interventions

DRUGCisplatin,fluorouracil

Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy, then receive cisplatin (80mg/m2 on day 1) and fluorouracil (800mg/m2 on Day 1 to 5) every four weeks for three cycles after completion of radiotherapy.

DRUGCisplatin

Patients receive radical radiotherapy and cisplatin (40mg/m2 on day 1) weekly during radiotherapy.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

No

Inclusion criteria

1. Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type) 2. Tumor staged as N2-3or T3-4N1 (according to 6th American Joint Committee on Cancer staging system) 3. No evidence of distant metastasis (M0) 4. Performance status: KPS ≥70 5. With normal liver function test (Alanine Aminotransferase、Aspartate Aminotransferase ≤2.5×upper limit of normal) 6. Renal: creatinine clearance ≥60ml/min 7. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥80g/L and platelet count ≥100000/μL 8. Written informed consent

Exclusion criteria

1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. 2. Age ≥70 or \<18 3. With a history of renal disease 4. Prior malignancy 5. Previous chemotherapy or radiotherapy 6. Patient is pregnant or lactating 7. Unstable cardiac disease requiring treatment. 8. Emotion disturbance

Design outcomes

Primary

Measure	Time frame	Description
Failure-free survival	2-yr	Failure-free survival is calculated from the date of randomization to the date of the first failure at any site.

Secondary

Measure	Time frame	Description
Overall survival, distant failure-free survival and locoregional failure-free survival	2-yr	Overall survival is calculated from randomization to death from any cause. For distant failure-free survival and locoregional failure-free survival analyses, the latencies to the first remote or local failure, respectively, are recorded.

Countries

China

Outcome results

None listed