Aggressive Thoracic Radiotherapy for Stage Ⅳ Non Small Cell Lung Cancer

Not Applicable

• Conditions: Thoracic Radiotherapy; Carcinoma, Non-Small-Cell Lung; Stage IV
• Interventions: Radiation: Aggressive Thoracic Radiotherapy

• Registration Number: NCT03565120
• Lead Sponsor: yu gengsheng

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-21
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-21
• Status Verified: 2018-12
• Study Start: 2018-12-10
• Last Update Submitted: 2018-12-23
• Last Update Posted: 2018-12-26
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm-R	Aggressive Thoracic Radiotherapy	patients in this arm will receive aggressive thoracic radiotherapy.

Primary Outcome Measures

Name	Time	Method
OS	two years after the beginning of first line systemic therapy	overall survival

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jiangmen central hospital; 🇨🇳 Jiangmen, Guangdong, China