Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

Thymoma and Thymic Carcinoma Clinical Trial

Official title:

A Randomized Phase III Study of Adjuvant Radiotherapy Versus Adjuvant Radiochemotherapy in Patients With Incomplete ResectionThymoma or Thymic Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02633514
• Other study ID #: 1508151-6
• Status: Recruiting
• Phase: Phase 3
• Start date: December 1, 2023
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: Fudan University
• Contact: Kailiang Wu, MD.PhD.
• Phone: +86 64175590
• Email: wukailiang[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate whether adjuvant radiochemotherapy after incomplete resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.

Description:

The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with thymoma or thymic carcinoma.However,whether patients with thymoma or thymic carcinoma could benefit from adjuvant radiochemotherapy after incomplete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiochemotherapy after incomplete resection can improve survival for thymoma or thymic carcinoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

18~75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed ; incomplete resection (R1 or R2);have adequate bone marrow, hepatic, and renal function;Patients receive incomplete 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.

Related Conditions & MeSH terms

• Carcinoma
• Thymoma
• Thymoma and Thymic Carcinoma
• Thymus Neoplasms

Intervention

Drug:
• Cisplatin
25mg/m2,iv gtt,d1-3
• Etoposide
75mg/m2,iv gtt,d1-3

Radiation:
• radiotherapy
60Gy/30Fx

Locations

Country	Name	City	State
China	Kailiang Wu	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	from registration to disease progression or death.	2 years
Secondary	Overall survival	from registration to death as a result of any cause	2 years
Secondary	Number of Participants with Treatment- Related Adverse Events as Assessed by CTCAE v4.0	Assessed by CTCAE v4.0	2 years