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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Xingwen Fa, Doctor
wenxingfan@126.com
+8613651669687
Time Frame
Start Date: 2024-04-09
Estimated Completion Date: 2030-05-01
Participants
Target number of participants: 172
Treatments
Active_comparator: Radiotherapy Arm
Radiotherapy (50Gy/25f), IMRT
Experimental: Chemoradiotherapy Arm
2 cycle of chemotherapy, and then radiotherapy of 50Gy/25f,and then another 2 cycle of chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov