Carcinoma, Non-Small-Cell Lung, Stage IV, Thoracic Radiotherapy
Conditions
Brief summary
This phase II trial studies the safety and efficacy of aggressive thoracic radiotherapy in treating patients with non-small cell lung cancer that has not progressed after the first line systemic therapy. In this trial, patients with stage Ⅳ non small cell lung cancer who did not progress after first line systemic therapy will receive the aggressive thoracic radiotherapy, and the safety and efficacy of aggressive thoracic radiotherapy will be evaluated. The primary end points of the study are overall survival (OS), the secondary end points are local control rate, local progression free survival(LPFS), PFS, and toxicity and quality of life(QOL).
Interventions
RADIATIONAggressive Thoracic Radiotherapy
The target of the radiotherapy includes primary tumor and the locoregional positive lymph nodes, with a dose(BED)≥53Gray(Gy)
Sponsors
yu gengsheng
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* histologically or cytologically confirmed NSCLC * stage IV disease * no progression after first line systemic therapy * 18 to 80 years of age * Karnofsky performance status(KPS) score ≥70% * no contraindications to radiation therapy * presumed ability to tolerate thoracic radiation therapy to a BED≥53Gy
Exclusion criteria
* a history of thoracic surgery, radiation therapy, or more than first line chemotherapy * pregnancy or lactation at the time of enrollment * previous malignancy or other concomitant malignant disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OS | two years after the beginning of first line systemic therapy | overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LPFS | 1 year after the beginning of first line systemic therapy | local progression free survival |
| PFS | 1 year after the beginning of first line systemic therapy | progression free survival |
| toxicity related to the radiotherapy | from the beginning of radiotherapy to the 3 month after the completion of radiotherapy | assess according to the National Cancer Institute-Common Terminology Criteria for Adverse Events 3.0 |
Countries
China
Contacts
Primary ContactLi chunming, master
Backup ContactYu Gengsheng, master
Outcome results
None listed