Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

Thymoma and Thymic Carcinoma Clinical Trial

Official title:

Phase Ⅱ Study of Concurrent Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636556
• Other study ID #: 1508151-5
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: February 2020

Study information

• Verified date: February 2020
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2020
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Thymoma
• Thymoma and Thymic Carcinoma
• Thymus Neoplasms

Intervention

Radiation:
• concurrent chemoradiation
The patients receive chemotherapy concurrent with Radiotherapy. The prescription dose is 60Gy in 30 fractions in 6 weeks.The chemotherapy regimen is cisplatin (25mg/m2,iv drip,d1-3) and etoposide (75mg/m2,iv drip,d1-3),q4w*4.

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	Objective response rate	Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria	3 months after treatment
Secondary	Overall survival	from registration to death as a result of any cause.	2 years
Secondary	Progression free survival	from registration to first documentation of disease progression or death.	2 years
Secondary	Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0	Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0	up to 2 years