Actively Recruiting
Postoperative Adjuvant Treatment for Thymic Cancer With Completed Resection Radiotherapy vs Chemoradiotherapy: A Prospective, Multicenter, Open-label, Phase III, Randomized Controlled Trial
Led by Fudan University · Updated on 2026-04-27
172
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the role of adjuvant chemotherapy in patients with thymic carcinoma who have undergone complete surgical removal of the tumor. This trial aims to determine whether adding chemotherapy to radiotherapy reduces the chance of the disease progressing and to assess the tolerance of a medium-dose chemotherapy regimen consisting of paclitaxel, cisplatin, and 5-FU. The study compares chemoradiotherapy with radiotherapy alone to address these questions. Participants will be assigned to one of two groups: one receiving radiotherapy alone (50 Gy over 25 fractions using IMRT) and the other receiving two cycles of chemotherapy followed by radiotherapy and then another two cycles of chemotherapy. The chemotherapy drugs are given intravenously every three weeks at specified doses. This design balances treatment effectiveness with potential side effects. Throughout the study, participants will have regular follow-ups every three months for the first two years, then every six months afterwards. Researchers will monitor disease-free survival over three years as the main outcome, along with overall survival and disease-specific survival. Safety assessments and laboratory tests will be conducted to ensure participants' well-being during the trial, which is expected to continue until 2030.
CONDITIONS
Brief Title
Postoperative Adjuvant Chemotherapy for Thymic Cancer (FUSCC-Thymic 3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 weeks
Participants receive either radiotherapy alone or a combination of chemotherapy and radiotherapy as postoperative adjuvant treatment for thymic cancer.
Multiple visits for chemotherapy and radiotherapy over the course of treatment
Duration - Up to 3 years
Participants are monitored for disease-free survival and overall health after completion of treatment.
Periodic follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 212013
Actively Recruiting
Research Team
X
Xingwen Fa, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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