Chemoradiotherapy for Limited Advanced Unresectable Thymic Epithelial Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2020-02-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Thymoma and Thymic Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Intensity modulated radiotherapy with VP-16/Cisplatin

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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chemoradiation

concurrent chemoradiation.

Group Type EXPERIMENTAL

concurrent chemoradiation

Intervention Type 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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No