Cisplatin-based and Carboplatin-based Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

Phase 3

Recruiting

• Conditions: NPC; Carboplatin; Cisplatin
• Interventions: Drug: Docetaxel,Carboplatin; Drug: Docetaxel,Cisplatin; Radiation: Carboplatin-based concurrent chemoradiotherapy; Radiation: Cisplatin-based concurrent chemoradiotherapy

• Registration Number: NCT03919552
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

The purpose of this study is to compare cisplatin-based with carboplatin-based chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC), in order to confirm the value of carboplatin-based chemoradiotherapy in NPC patients.

Detailed Description

Patients presented with non-keratinizing NPC and stage T3-4NxM0/TxN2-3M0 are randomly assigned to receive cisplatin-based (control arm) with carboplatin-based (investigational arm) chemoradiotherapy. Patients in the investigational arm receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and carboplatin (AUC 5 on day 1) every three weeks for three cycles during radiotherapy. Patients in the control arm receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during radiotherapy. Patients are stratified according to stage. The primary end point is overall survival (OS). Secondary end points include failure-free survival (FFS), 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.

Study Timeline

• Study Start: 2018-01-31
• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2019-04-14
• Study First Posted: 2019-04-18
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-18
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 482

Inclusion Criteria

• Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
• Tumor staged as T3-4Nx/TxN2-3 (according to the 8th 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 ≥65 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carboplatin	Docetaxel,Carboplatin	Patients receive carboplatin (AUC 4 on day 1) every three weeks
Carboplatin	Carboplatin-based concurrent chemoradiotherapy	Patients receive carboplatin (AUC 4 on day 1) every three weeks
Cisplatin	Docetaxel,Cisplatin	Patients receive cisplatin (75mg/m2 on day 1) every three weeks
Cisplatin	Cisplatin-based concurrent chemoradiotherapy	Patients receive cisplatin (75mg/m2 on day 1) every three weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Toxic effects	3-year	Radiation and chemotherapy related toxic effects as assessed by CTCAE v4.0.
Locoregional failure-free survival	3-year	Locoregional failure-free survival is calculated from randomisation to the first locoregional failure.
Distant failure-free survival	3-year	Distant failure-free survival is calculated from randomisation to the first locoregional 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.	The initial response rates is calculated at the time 1 week after completion of the last cycle of induction chemotherapy and 16 weeks after completion of radiotherapy.
Overall survival	3-year	Overall survival is calculated from randomization to death from any cause.

Trial Locations

Locations (1)

Southern medical university; 🇨🇳 Guangzhou, Guangdong, China