RecruitingNot ApplicableNCT05352321

Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Newly Diagnosed Resectable Nasopharyngeal Carcinoma

Multicenter Randomized Controlled Trial of Surgery Plus Target-reduction Chemoradiotherapy vs Regular Chemoradiotherapy for Newly Diagnosed Resectable Nasopharyngeal Carcinoma


Sponsor

Sun Yat-sen University

Enrollment

264 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Through a prospective clinical trial, we intend to combine surgery, induction chemotherapy, target-reduction intensity-modulated radiotherapy and concurrent chemotherapy as an experimental treatment for patients with newly diagnosed resectable nasopharyngeal carcinoma to illuminate whether combined surgery could bring patients better local-regional control and lower adverse reactions.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment strategies for people with a specific type of nasopharyngeal carcinoma (cancer of the back of the nose) that can be removed surgically: one group receives surgery plus chemotherapy and radiation targeting only the remaining disease areas, while the other receives standard chemotherapy and radiation without surgery. **You may be eligible if...** - Your nasopharyngeal cancer is stage II–IVA (per AJCC 8th edition) and has been confirmed as the non-keratinizing type - Your primary tumor and lymph nodes are considered surgically removable based on pre-treatment imaging - You have adequate organ function (blood counts, liver, kidney) **You may NOT be eligible if...** - Your cancer has already spread to distant organs or is a recurrence - You have severe heart or lung problems that prevent surgery - Your tumor invades the internal carotid artery or is too close to major blood vessels - 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

DRUGGemcitabine

for induction chemotherapy

DRUGCisplatin

for induction and concurrent chemotherapy

RADIATIONregular intensity-modulated radiotherapy

in active comparator arm

PROCEDUREsurgery

in experimental arm

RADIATIONTarget-reduction intensity-modulated radiotherapy

in experimental arm


Locations(2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT05352321


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