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

NCT06402708 | Recruiting Phase 3

• 1 other identifier: 2403293-1
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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. 1.Does adjuvant chemotherapy decrease disease progression?
2. 2.Does medium dose of three drugs (paclitaxel, cisplatin, 5-FU) well tolerance?
3. 3.Take radiotherapy (50Gy/25f) with or without 4 cycles of chemotherapy (TPF).
4. 4.Follow up every 3 months in the first two year, and then every 6 months.

Conditions

Thymic Carcinoma

Keywords

thymic carcinoma; adjuvant treatment; radiotherapy; chemotherapy

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  From surgery to any disease relapse or death

  3 year

Secondary Outcomes (2)

• Overall survival

  3 year

• Disease Specific Survival

  3 year

Study Arms (2)

Radiotherapy Arm

ACTIVE COMPARATOR

Radiotherapy (50Gy/25f), IMRT

Radiation: Radiotherapy

Chemoradiotherapy Arm

EXPERIMENTAL

2 cycle of chemotherapy, and then radiotherapy of 50Gy/25f，and then another 2 cycle of chemotherapy

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

paclitaxel 60mg/m2, ivgtt; cisplatin 30mg/m2, ivgtt; 5-FU 500mg/m2, ivgtt and 500mg/m2, civ 24h; calcium folinate 200mg; q3w.

Chemoradiotherapy Arm

Radiotherapy RADIATION

IMRT, 50Gy/25f

Radiotherapy Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 212013, China

RECRUITING

MeSH Terms

Conditions

Thymoma

Interventions

Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Xingwen Fa, Doctor

CONTACT

+8613651669687; wenxingfan@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: April 9, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)