RecruitingPhase 3NCT04898374

Induction Versus Adjuvant Gemcitabine/Cisplatin in Locally Advanced Non-metastatic Nasopharyngeal Carcinoma

Induction Versus Adjuvant Gemcitabine/Cisplatin in Locally Advanced Non-metastatic Nasopharyngeal Carcinoma: A Randomized Phase III Trial


Sponsor

Kuwait Cancer Control Center

Enrollment

120 participants

Start Date

May 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The standard of care for locally advanced nasopharyngeal carcinoma is radical chemoradiation(CRT).Recent advances in radiation techniques and supportive measures resulted in improvemnent of locoregional control and quality of life.However distant failure is still the main challenging reason of poor survival Addition of systemic therapy to concurrent CRT is widely used and accepted as an option to reduce these failures ,however selection of chemotherapy regimen and timing in relation to CRT is controversial. Doublet and triplet chemotherapy regimens using cisplatin and 5FU are throughly investigated in this setting.Inspite of significant improvement in disease free survival and overall survival they were poorly tolerated.Hence,minority of patients in the daily practice could tolerate those studied regimens as propsed. Recently, in multicenter randomized trial, Zhang and his group investigated gemcitabine and cisplatin as induction chemotherapy (ICT) added to CRT.It showed improvement in recurrence free survival and overall survival.More importantly 96.7% of the experimental arm completed the treatment protocol. This was further confirmed by an updated network of meta analysis by Bongiovanni et al.Again the question of "when" is still valid.Our proposal is to compare tolerable regimen in induction versus adjuvant settings.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two timing approaches for chemotherapy — given before versus after radiation — in people with locally advanced nasopharyngeal cancer (a cancer in the back of the nose and throat). Researchers want to find out which approach works better. **You may be eligible if...** - You have been newly diagnosed with nasopharyngeal carcinoma confirmed by biopsy - Your cancer is stage III (excluding T3N0) or stage IVA - You are between 18 and 69 years old - You are in generally good health (able to carry out normal daily activities) - Your blood counts, kidney function, and liver function meet study requirements **You may NOT be eligible if...** - Your cancer has spread to other parts of your body - You have received chemotherapy in the past 3 years - You have had previous surgery or radiation to the head or neck for this tumor - You are pregnant or breastfeeding - You have HIV or a serious heart condition - You have had a severe allergic reaction to cisplatin or gemcitabine 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

DRUGGemcitabin/cisplatin

chemotherapy combination


Locations(1)

Kuwait Cancer Control Center

Kuwait City, Kuwait

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NCT04898374


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