Postoperative Adjuvant Chemotherapy for Thymic Cancer (FUSCC-Thymic 3) (NCT06402708) | Clinical Trial Compass
RecruitingPhase 3
Postoperative Adjuvant Chemotherapy for Thymic Cancer (FUSCC-Thymic 3)
China172 participantsStarted 2024-04-09
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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);