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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Induction Chemotherapy Plus Radiotherapy Alone Versus Induction Chemotherapy Plus Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04414566
• Other study ID #: 2020HXFH037
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 1, 2020
• Est. completion date: May 30, 2025

Study information

• Verified date: May 2020
• Source: West China Hospital
• Contact: Xingchen Peng, MD, PhD
• Phone: +86 18980606753
• Email: pxx2014[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 562
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil
Patients receive GP gemcitabine (1000 mg/m^2 d1,8) and cisplatin (80mg/m^2 d1) or TPF docetaxel (60mg/m^2 on day 1), cisplatin (60mg/m^2 on day 1) and fluorouracil (600mg/m^2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.

Radiation:
• IMRT
Intensity modulated-radiotherapy (IMRT) is given as 2.0 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
• IMRT and concurrent cisplatin
Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor, concurrently with cisplatin 100 mg/m^2 every 3 weeks for 3 cycles.

Locations

Country	Name	City	State
China	Xingchen Peng	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival	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.	3-year
Secondary	Overall survival	Overall survival is calculated from randomization to death from any cause.	3-year
Secondary	Locoregional recurrence-free survival	Locoregional recurrence-free survival is calculated from randomization to the first locoregional recurrence.	3-year
Secondary	Distant metastasis-free survival	Distant metastasis-free survival is calculated from randomization to the first remote metastases.	3-year
Secondary	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
Secondary	Number of participants with adverse events	Incidence of acute toxicity	Every week during treatment, up to 4 weeks after treatment.