NCT06402708 Postoperative Adjuvant Chemotherapy for Thymic Cancer (FUSCC-Thymic 3)
| NCT ID | NCT06402708 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Thymic Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 172 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 172 participants in total. It began in 2024-04-09 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06402708 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Thymic Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06402708 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 172 participants.
Is NCT06402708 currently recruiting?
Yes, NCT06402708 is actively recruiting participants. Contact the research team at wenxingfan@126.com for enrollment information.
Where is the NCT06402708 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06402708 clinical trial?
NCT06402708 is sponsored by Fudan University. The trial plans to enroll 172 participants.