Recruiting

A Randomized Phase III Prospective Study of Induction Chemotherapy Combined With Concurrent Chemoradiotherapy Versus Induction Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma

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What is being tested

Gemcitabine,Cisplatin

+ Intensity-modulated radiation therapy (IMRT)

+ Cisplatin

DrugRadiation
Who is being recruted

Nasopharyngeal Carcinoma+11

+ Carcinoma

+ Head and Neck Neoplasms

From 18 to 65 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 2022
See protocol details

Summary

Principal SponsorWei Jiang
Study ContactWei Jiang, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 11, 2022

Actual date on which the first participant was enrolled.

Patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma will be randomized in a 1:1 ratio to experimental arm and active comparator arm. Patients in experimental arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration. Patients in active comparator arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 3 cycles during IMRT.

Official TitleA Randomized Phase III Prospective Study of Induction Chemotherapy Combined With Concurrent Chemoradiotherapy Versus Induction Chemotherapy Combined With Radiotherapy Alone in Locoregionally Advanced Nasopharyngeal Carcinoma
Principal SponsorWei Jiang
Study ContactWei Jiang, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

440 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Nasopharyngeal CarcinomaCarcinomaHead and Neck NeoplasmsStomatognathic DiseasesNasopharyngeal DiseasesNasopharyngeal NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialOtorhinolaryngologic DiseasesOtorhinolaryngologic NeoplasmsPharyngeal DiseasesPharyngeal Neoplasms

Criteria

10 inclusion criteria required to participate
Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type);

Tumor staged as III-IVb (according to the 8th AJCC edition);

No pregnant female;

Age between 18-65;

Show More Criteria

4 exclusion criteria prevent from participating
Disease progression in the process of the treatment;

The presence of uncontrolled life-threatening illness;

History of previous radiotherapy or chemotherapy;

Pregnancy or lactation.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT ) Combined Concurrent Chemotherapy

Group II

Experimental
Induction Chemotherapy(CT) Followed by Intensity-modulated Radiation Therapy (IMRT )alone

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Affiliated Hospital of Guilin Medical University

Guilin, ChinaOpen Affiliated Hospital of Guilin Medical University in Google Maps
Recruiting

Wuzhou Red Cross Hospital

Wuzhou, China
Recruiting
2 Study Centers