Adjuvant chemotherapy for thymic cancer after surgery

Postoperative Adjuvant Treatment for Thymic Cancer With Completed Resection (Radiotherapy vs Chemoradiotherapy): A Prospective, Multicenter, Open-label, Phase III, Randomized Controlled Trial

This study is testing if adding chemotherapy to radiation treatment after surgery helps people with thymic cancer stay healthier and avoid the cancer coming back.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 172 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06402708 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of adjuvant chemotherapy in patients with thymic carcinoma who have undergone complete surgical resection. It will compare the outcomes of patients receiving chemoradiotherapy versus those receiving only radiotherapy to determine if the addition of chemotherapy reduces disease progression. Participants will receive a medium dose of a three-drug chemotherapy regimen (paclitaxel, cisplatin, and 5-FU) alongside radiotherapy, with follow-up assessments scheduled every three months for the first two years. The study seeks to clarify the optimal adjuvant treatment approach for this rare cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 who have undergone complete resection of thymic carcinoma within the last three months.

Not a fit: Patients with severe organ dysfunction or those with a second primary tumor may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve disease-free survival rates for patients with thymic carcinoma after surgery.

How similar studies have performed: Previous studies have shown promising results with similar chemotherapy regimens in other cancers, but this specific approach for thymic carcinoma is novel.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xingwen Fa, Doctor

Conditions Thymic Carcinoma; thymic carcinoma; adjuvant treatment; radiotherapy; chemotherapy