Postoperative Adjuvant Chemotherapy for Thymic Cancer (FUSCC-Thymic 3)

April 22, 2026 updated by: Kailiang Wu, Fudan University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Thymic carcinomas are rare neoplasms found in the anterior mediastinum, with an incidence of 0.38 cases per 100,000 people. Surgery is the primary treatment for patients with thymic carcinomas, and complete surgical resection proves fundamental for enhancing survival. However, the necessity for adjuvant therapy and the optimal type thereof for patients who have undergone complete resection remain unclear due to the lack of high-quality studies.

Our previous retrospective study found that radiotherapy improved overall survival and disease progression free survival significantly for all patients with thymic carcinoma and completed resection, however, chemotherapy only improved disease progression free survival for patients of stage III/IV. We also found that chemotherapy regimens containing paclitaxel were an advantageous combination for thymic cancer, and 1 or 2 cycles of adjuvant chemotherapy were better than more cycles, suggesting reduced dose chemotherapy.

DCF (docetaxel, cisplatin, 5-FU) or TPF (paclitaxel, cisplatin, 5-FU) were widely used in head and neck, esophageal, stomach, and anal canal cancer, and better effect were presented. However, the toxicity of full dose was too toxic to tolerate. Our previous experience in esophageal cancer found TPF with 2/3 of standard dose was well tolerance. Therefore, medium dose of TPF three drugs chemotherapy were chosed to balance efficacy and toxicity.

Study Type

Interventional

Enrollment (Estimated)

172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 212013
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radiotherapy Arm
Radiotherapy (50Gy/25f), IMRT
Radiation: Radiotherapy
IMRT, 50Gy/25f
Experimental: Chemoradiotherapy Arm
2 cycle of chemotherapy, and then radiotherapy of 50Gy/25f，and then another 2 cycle of chemotherapy
Drug: Chemotherapy
paclitaxel 60mg/m2, ivgtt; cisplatin 30mg/m2, ivgtt; 5-FU 500mg/m2, ivgtt and 500mg/m2, civ 24h; calcium folinate 200mg; q3w.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 3 year
From surgery to any disease relapse or death
3 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 3 year
from surgery to any death
3 year
Disease Specific Survival
Time Frame: 3 year
from surgery to death related to thymic carcinoma
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2024

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2030

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 3, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2403293-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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