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Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

Fudan University logo

Fudan University

Status

Completed

Conditions

Thymoma and Thymic Carcinoma

Treatments

Radiation: concurrent chemoradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT02636556
1508151-5

Details and patient eligibility

About

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

Full 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.

Enrollment

56 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

56 participants in 1 patient group

chemoradiation
Experimental group
Description:
concurrent chemoradiation.
Treatment:
Radiation: concurrent chemoradiation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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