Skip to main content
OpenTrials
Completed

NCT Number: NCT02636556

Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thymoma and Thymic Carcinoma Hemic and Lymphatic Diseases Lymphatic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Thoracic Neoplasms Thymoma Thymus Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kailiang Wu

Shanghai, Shanghai Municipality, 20032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Concurrent Chemoradiation

Radiation

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.

Primary outcomes

  1. Objective response rate

    Time frame: 3 months after treatment

    Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria

Secondary outcomes

  1. Overall survival

    Time frame: 2 years

    from registration to death as a result of any cause.

  2. Progression free survival

    Time frame: 2 years

    from registration to first documentation of disease progression or death.

  3. Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0

    Time frame: up to 2 years

    Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2018
Study completion
2020
First posted
Dec 21, 2015
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.