RecruitingPhase 3NCT04136886

Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma

Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT)


Sponsor

Sun Yat-sen University

Enrollment

346 participants

Start Date

Jan 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding chemotherapy at the same time as re-irradiation (radiation therapy given a second time) improves outcomes for people with locally recurrent nasopharyngeal carcinoma — a type of cancer at the back of the nose near the throat — that has come back after initial treatment. **You may be eligible if...** - You have confirmed locally recurrent nasopharyngeal carcinoma at stage T3 or T4 (advanced local tumor) - Your cancer has not spread to distant parts of the body - It has been more than 1 year since you finished your first course of radiation - You are between 18 and 70 years old with good performance status (ECOG 0-2) - Your blood counts and organ function are within acceptable limits **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have evidence of only regional (lymph node) recurrence, not local - You have had other cancers (with some exceptions) - You are pregnant or breastfeeding - You have severe heart, brain, or lung problems - Your tissue in the back of the throat has areas of severe dead tissue (necrosis) 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

DRUGCisplatin

cisplatin is to give from the first Day of radiation therapy D1,D22 Q3W for 2 cycles Radiation: IMRT IMRT is to give 60Gy in 27 fraction

RADIATIONIMRT

Radiation: IMRT IMRT is to give 60Gy in 27 fraction


Locations(1)

WangHanYu

Guangzhou, Guangdong, China

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NCT04136886


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