Induction Chemotherapy Plus Radiotherapy Alone in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Phase 3

Not yet recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil; Radiation: IMRT; Radiation: IMRT and concurrent cisplatin

• Registration Number: NCT04414566
• Lead Sponsor: West China Hospital

Brief Summary

The purpose of this study is to compare induction chemotherapy (TPF or GP) plus radiotherapy alone with induction chemotherapy plus concurrent chemoradiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (LA-NPC).

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-24
• Study First Submitted QC: 2020-05-31
• Last Update Submitted: 2020-05-31
• Study Start: 2020-06-01
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04
• Primary Completion: 2022-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 562

Inclusion Criteria

• Newly pathologically confirmed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, ie WHO type II or III).
• Age ≥ 18 and ≤ 65 years old.
• Tumor staged as III/IVa (according to the 8th AJCC edition).
• No evidence of distant metastasis (M0).
• Satisfactory performance status: Karnofsky scale (KPS) ≥ 70.
• Adequate marrow: White blood cells (WBC) ≥ 4 × 10^9/L, hemoglobin (HGB) ≥ 90 g/L, platelets (PLT) ≥ 100 × 10^9/L (or within the normal range of the laboratory)
• 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.
• Written informed consent.

Exclusion Criteria

• WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
• Age > 65 or < 18.
• Treatment with palliative intent.
• Previous history of malignant tumors, well-treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ outer.
• Pregnancy or lactation.
• History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume), chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
• Any other serious diseases, which may bring greater risk or affect the compliance of the test, 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
IC plus CCRT	gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil	Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy.
IC plus RT	gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil	Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m\^2) every three weeks for three cycles during radiotherapy.
IC plus RT	IMRT	Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy and cisplatin (100mg/m\^2) every three weeks for three cycles during radiotherapy.
IC plus CCRT	IMRT and concurrent cisplatin	Patients receive GP(gemcitabine+cisplatin) or TPF(docetaxel+cisplatin+fluorouracil) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3-year	Disease-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first.

Secondary Outcome Measures

Name	Time	Method
Overall survival	3-year	Overall survival is calculated from randomization to death from any cause.
Number of participants with adverse events	Every week during treatment, up to 4 weeks after treatment.	Incidence of acute toxicity
Locoregional recurrence-free survival	3-year	Locoregional recurrence-free survival is calculated from randomization to the first locoregional recurrence.
Distant metastasis-free survival	3-year	Distant metastasis-free survival is calculated from randomization to the first remote metastases.
Objective response rates after treatments	At the end of Cycle 3 of induction chemotherapy (each cycle is 21 days) and 16 weeks after completion of radiotherapy

Trial Locations

Locations (1)

Xingchen Peng; 🇨🇳 Chengdu, Sichuan, China