Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thymic Carcinoma | Thymus Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy Arm
- description
- Radiotherapy (50Gy/25f), IMRT
- interventionNames
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Chemoradiotherapy Arm
- description
- 2 cycle of chemotherapy, and then radiotherapy of 50Gy/25f，and then another 2 cycle of chemotherapy
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 3 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntarily participate and sign an informed consent form in writing; 2. Age range from 18 to 75 years old, regardless of gender; 3. Within 3 months after the surgery is completed; 4. Histologically diagnosed with thymic cancer; 5. Complete resection based on surgical records, pathological reports, and postoperative imaging; 6. Masaoka stage: I-III 7. No severe hematopoietic function, heart, lung, liver, kidney dysfunction, or immune deficiency; 8. 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: 1. 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); 2. Symptomatic coronary heart disease, left heart failure, uncontrollable seizures, or loss of self-awareness due to mental illness; 3. Pregnancy and lactation period; 4. Patients with drug addiction, chronic alcoholism and AIDS; 5. Researchers believe that participants are not suitable for this experiment.
References
Publications (0)
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