Clinical trial NCT03565120: Aggressive Thoracic Radiotherapy for Stage Ⅳ Non Small Cell Lung Cancer
Official title: The Efficacy and Toxicity of Aggressive Thoracic Radiotherapy for Stage Ⅳ Non-Small Cell Lung Cancer Patients With Controlled Extrathoracic Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Stage IV
Thoracic Radiotherapy
Lead sponsor: Jiangmen Central Hospital
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: OS
timeFrame: two years after the beginning of first line systemic therapy
Secondary outcomes:
measure: LPFS
timeFrame: 1 year after the beginning of first line systemic therapy
measure: PFS
timeFrame: 1 year after the beginning of first line systemic therapy
measure: toxicity related to the radiotherapy
timeFrame: from the beginning of radiotherapy to the 3 month after the completion of radiotherapy
Other outcomes:
Locations:
city: Jiangmen
country: China
facility: Jiangmen central hospital
state: Guangdong
Study officials:
affiliation: jiangmen cenctral hospital
name: Yu Gengsheng, master
role: STUDY_DIRECTOR
References:
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