RecruitingPhase 3NCT05044117

Single-agent Capecitabine as Metronomic Chemotherapy in LAHNSCC (CMHN)

Single-agent Capecitabine as Metronomic Chemotherapy in Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (CMHN):A Phase III, Multicentre, Randomised Controlled Trial


Sponsor

Sun Yat-sen University

Enrollment

220 participants

Start Date

Oct 18, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to investigate whether the addition of metronomic capecitabine to the standard treatment can improve prognosis in locoregionally advanced head and neck squamous cell carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether low-dose continuous capecitabine (an oral chemotherapy) taken after completing standard treatment can reduce the risk of head and neck squamous cell cancer coming back in patients who had locally advanced disease. **You may be eligible if...** - You have completed treatment (surgery plus radiation, or chemoradiation) for stage III or IV squamous cell cancer of the mouth, throat, larynx, or hypopharynx - You are within 4–8 weeks of finishing your last radiation dose - There is no sign of remaining or spread cancer - Your blood counts and organ function are adequate - Your performance status is ECOG 0 or 1 **You may NOT be eligible if...** - Your cancer has come back or spread at the time of enrollment - You have had a prior head and neck cancer - You have significant heart, kidney, or liver disease - You are pregnant or breastfeeding - You have a known allergy to capecitabine or fluorouracil - You cannot swallow tablets 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

DRUGCapecitabine

Metronomic capecitabine (650 mg/m2 bid, d1-21, q3w) for 1 year


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT05044117


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