Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection

Overview

This study is designed to investigate whether adjuvant radiotherapy after complete resection has a better survival for stage II or III thymoma.

Full Title of Study: “An Open-label, Multi-center, Randomized Phase III Study of Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2025

Detailed Description

It is confirmed by many studies that patients of thymoma with complete resection have better prognosis than those with either incomplete resection or without surgery. However,whether patients with stage II or III thymoma could benefit from adjuvant radiotherapy after complete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiotherapy after complete resection can improve survival for stage II or III thymoma.

Interventions

  • Radiation: adjuvant radiotherapy
    • 50Gy/25Fx

Arms, Groups and Cohorts

  • Experimental: radiotherapy group
    • complete resection and adjuvant radiotherapy
  • No Intervention: observation group
    • complete resection

Clinical Trial Outcome Measures

Primary Measures

  • DFS (Disease free survival)
    • Time Frame: 5 years
    • from registration to disease progression or death.

Secondary Measures

  • OS(overall survival)
    • Time Frame: 5 years
    • from registration to death
  • Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0
    • Time Frame: 5 years
    • Adverse Events Assessed by CTCAE v4.0

Participating in This Clinical Trial

Inclusion Criteria

18~75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed masaoka stage II or III thymoma; Have adequate bone marrow, hepatic, and renal function; Patients receive complete resection within 3 months; Written informed consent. Exclusion Criteria:

Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kailiang Wu, professor – Fudan University
  • Overall Contact(s)
    • Kailiang Wu, MD.PhD., +86 64175590, wukailiang@aliyun.com

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