Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

Not Applicable

Completed

• Conditions: Thymoma and Thymic Carcinoma
• Interventions: Radiation: concurrent chemoradiation

• Registration Number: NCT02636556
• Lead Sponsor: Fudan University

Brief Summary

This study is designed to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Detailed Description

Complete resection is difficult to achieve without damaging the main organs in advanced thymoma or thymic carcinoma. 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 advanced thymoma or thymic carcinoma. However, whether concurrent chemoradiotherapy is safety in advanced thymoma or thymic carcinoma is still unknown. The purpose of this study is to evaluate the feasibility and safety of concurrent chemoradiotherapy for limited advanced unresectable thymoma or thymic carcinoma.

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-18
• Study First Posted: 2015-12-21
• Primary Completion: 2018-08
• Status Verified: 2020-02
• Study Completion: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1.18~75 years old; 2.Eastern Cooperative Oncology Group performance status of 0 to 2; 3.Pathologically or cytologically confirmed untreated thymoma or thymic carcinoma; 4.Unresectable, limited adanced disease could be encompassed within a tolerable radiotherapy field; 5.Have adequate bone marrow, hepatic, and renal function; 6.Patients who cannot receive surgery resection; 7.Written informed consent.

Exclusion Criteria

1. Distant metastases could not be encompassed within a tolerable radiotherapy field;
2. Underwent surgery, radiotherapy or chemotherapy before entering this study ;
3. Have other malignancy history excluding carcinoma in situ of cervix in the previous five years;
4. Active clinical pulmonary infection;
5. Pregnant or nursing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chemoradiation	concurrent chemoradiation	concurrent chemoradiation.

Primary Outcome Measures

Name	Time	Method
Objective response rate	3 months after treatment	Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria

Secondary Outcome Measures

Name	Time	Method
Overall survival	2 years	from registration to death as a result of any cause.
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0	up to 2 years	Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
Progression free survival	2 years	from registration to first documentation of disease progression or death.

Trial Locations

Locations (1)

Kailiang Wu; 🇨🇳 Shanghai, Shanghai, China