Aggressive Thoracic Radiotherapy for Stage Ⅳ Non Small Cell Lung Cancer

yu gengsheng

Status: Unknown

Conditions: Stage IV; Thoracic Radiotherapy; Carcinoma, Non-Small-Cell Lung

Treatments: Radiation: Aggressive Thoracic Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03565120

ATR-NSCLC

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Arm-R

Experimental group

Description:

patients in this arm will receive aggressive thoracic radiotherapy.

Treatment:

Radiation: Aggressive Thoracic Radiotherapy