RecruitingPhase 3NCT06402708

Postoperative Adjuvant Chemotherapy for Thymic Cancer (FUSCC-Thymic 3)

Postoperative Adjuvant Treatment for Thymic Cancer With Completed Resection (Radiotherapy vs Chemoradiotherapy): A Prospective, Multicenter, Open-label, Phase III, Randomized Controlled Trial


Sponsor

Fudan University

Enrollment

172 participants

Start Date

Apr 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn the role of adjuvant chemotherapy for patients with thymic carcinoma and completed resection. The main questions it aims to answer are: 1. Does adjuvant chemotherapy decrease disease progression? 2. Does medium dose of three drugs (paclitaxel, cisplatin, 5-FU) well tolerance? Researchers will compare chemoradiotherapy to radiotherapy to see whether chemoradiotherapy could decrease disease progression or not. Participants will: 1. Take radiotherapy (50Gy/25f) with or without 4 cycles of chemotherapy (TPF). 2. Follow up every 3 months in the first two year, and then every 6 months.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether chemotherapy given after surgery can improve outcomes in patients who have had their thymic cancer (a rare cancer that grows in the thymus gland in the chest) completely removed. **You may be eligible if...** - You are between 18 and 75 years old with a confirmed diagnosis of thymic cancer - Your surgery was completed within the past 3 months and the entire tumor was removed - Your cancer was at an early-to-intermediate stage (Masaoka stage I–III) - Your blood counts and organ function (liver, kidneys, heart, lungs) are within acceptable ranges **You may NOT be eligible if...** - You have another active cancer (with some exceptions for early or previously cured cancers) - You have serious heart disease, uncontrolled seizures, or a severe psychiatric condition - You are pregnant or breastfeeding - You have a history of drug addiction or alcoholism - You have HIV/AIDS 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

DRUGChemotherapy

paclitaxel 60mg/m2, ivgtt; cisplatin 30mg/m2, ivgtt; 5-FU 500mg/m2, ivgtt and 500mg/m2, civ 24h; calcium folinate 200mg; q3w.

RADIATIONRadiotherapy

IMRT, 50Gy/25f


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06402708


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