RecruitingPhase 1NCT06611150

Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma

A Phase I Study of Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma


Sponsor

Sun Yat-sen University

Enrollment

24 participants

Start Date

Aug 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to determine the maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy in nasopharyngeal carcinoma. Researchers will observe the toxicity response of patients receiving nab-paclitaxel at 180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m².


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding nab-paclitaxel (a chemotherapy drug delivered in a special nanoparticle form) to standard radiation therapy improves outcomes for patients with Stage III–IVa nasopharyngeal carcinoma — a type of head and neck cancer that starts in the back of the nose. The study is looking at whether this combination is safe and more effective than radiation alone or with standard chemotherapy. **You may be eligible if...** - You have been diagnosed with nasopharyngeal carcinoma confirmed by biopsy - Your cancer is Stage III or IVa - You are between 18 and 70 years old - You are in good general health (performance status 0–1) - Your organs can tolerate chemotherapy and radiation **You may NOT be eligible if...** - You have had another cancer in the past 5 years (except certain very early-stage cancers) - You have heart failure, unstable angina, recent heart attack, active serious infections, psychiatric disorders, or major social/family circumstances that prevent participation 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

DRUGNab-paclitaxel

All participants enrolled in the study will be treated with nab-paclitaxel during radical radiotherapy following induction chemotherapy. The doses are increased progressively (180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m²).


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06611150


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