Thymoma and Thymic Carcinoma
Conditions
Keywords
thymoma, thymic carcinoma, chemoradiotherapy, inoperable
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.
Interventions
RADIATIONconcurrent 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.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Intensity modulated radiotherapy with VP-16/Cisplatin
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 3 months after treatment | Evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Overall survival | 2 years | from registration to death as a result of any cause. |
| Progression free survival | 2 years | from registration to first documentation of disease progression or death. |
Countries
China
Outcome results
None listed