RecruitingPhase 3NCT05979961

Phase III Trial of Concurrent Chemotherapy Alone in Patients With Low-risk Nasopharyngeal Carcinoma

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


Sponsor

Sun Yat-sen University

Enrollment

454 participants

Start Date

Sep 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to compare concurrent chemoradiotherapy (CCRT) alone with induction chemotherapy (gemcitabine+cisplatin) plus CCRT in patients with low-risk locoregionally advanced nasopharyngeal carcinoma(NPC).


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether chemotherapy alone — without the usual addition of radiation — is enough to treat certain patients with low-risk nasopharyngeal carcinoma (a type of cancer in the back of the nose and throat). The goal is to reduce treatment side effects while maintaining effectiveness. **You may be eligible if:** - You are 18–70 years old - You have a newly diagnosed, confirmed nasopharyngeal cancer of a specific tissue type - Your cancer is at stage III–IVa (but not the most advanced substages) - Your EBV virus levels in the blood are below 4,000 copies/mL - You are male, or a female who is not pregnant - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if:** - Your cancer has spread to distant parts of the body - You have a different tissue type of nasopharyngeal cancer (keratinizing or basaloid type) - You have already received radiation, chemotherapy, or surgery for this cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONIMRT and concurrent cisplatin

Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated radiotherapy (IMRT)

DRUGgemcitabine and cisplatin (Induction chemotherapy)

Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy


Locations(8)

Guangzhou Panyu Central Hospital

Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Cancer Hospital of Guizhou Province

Guiyang, Guizhou, China

Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College,Huazhong University of Science and Technology;

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

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NCT05979961


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