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
Fudan University
172 participants
Apr 9, 2024
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
Inclusion Criteria8
- Voluntarily participate and sign an informed consent form in writing;
- Age range from 18 to 75 years old, regardless of gender;
- Within 3 months after the surgery is completed;
- Histologically diagnosed with thymic cancer;
- Complete resection based on surgical records, pathological reports, and postoperative imaging;
- Masaoka stage: I-III
- No severe hematopoietic function, heart, lung, liver, kidney dysfunction, or immune deficiency;
- White blood cells ≥ 3 × 109/L; Neutrophils ≥ 1.5 × 109/L; Hemoglobin ≥ 10 g/dL; Platelets ≥ 100 × 109/L; Total bilirubin ≤ 1.5 times the upper limit of normal value; AST (SGOT)/ALT (SGPT) ≤ 2.5 times the upper limit of normal value; Creatinine ≤ 1.5 times the upper limit of normal value;
Exclusion Criteria5
- Having a second primary tumor (excluding cured non malignant melanoma of the skin, papillary thyroid carcinoma, stage I seminomatoma, cervical carcinoma in situ, or other curable tumors that have been tumor free for more than 3 years after treatment);
- Symptomatic coronary heart disease, left heart failure, uncontrollable seizures, or loss of self-awareness due to mental illness;
- Pregnancy and lactation period;
- Patients with drug addiction, chronic alcoholism and AIDS;
- Researchers believe that participants are not suitable for this experiment.
Interventions
paclitaxel 60mg/m2, ivgtt; cisplatin 30mg/m2, ivgtt; 5-FU 500mg/m2, ivgtt and 500mg/m2, civ 24h; calcium folinate 200mg; q3w.
IMRT, 50Gy/25f
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06402708