Radiotherapy to the Primary in Metastatic Non-small Cell Lung Cancer Patients

Phase 3

Completed

• Conditions: Radiation Therapy; Non-Small Cell Carcinoma of Lung, TNM Stage 4
• Interventions: Drug: first line systemic therapy; Radiation: 3D radiotherapy or IMRT

• Registration Number: NCT04776083
• Lead Sponsor: Menoufia University

Brief Summary

study the effect of radiotherapy to the primary lesion after first line systemic therapy in metastatic non-small cell lung cancer patients.

Detailed Description

Metastatic non-small cell lung cancer patients after receiving their first line systemic therapy according to their genetic mutation will be randomized to follow up versus radiotherapy to the primary lesion.

Study Timeline

• Study Start: 2020-09-25
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-01
• Primary Completion: 2023-11-25
• Study Completion: 2023-11-25
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Confirmed histological diagnosis of NSCLC.
2. Stage IV disease.
3. Patients with P.S ≤ 2.
4. finished at least 4 cycles of platinum-based doublet chemotherapy if patient has no diver mutation, or at least 3 months of anti-EGFR, Anti-ALK according to their driver mutation with SD, PR or CR.

Exclusion Criteria

1. History of prior irradiation to the lung.
2. residual Malignant pleural or pericardial effusion at randomization time.
3. History of prior malignant tumor likely to interfere with the treatment protocol.
4. Severe comorbidities as measured by morbidity index.
5. Disease progression on first line systemic therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radiotherapy arm	3D radiotherapy or IMRT	after first line systemic therapy, patients will receive radiotherapy to the primary lesion, hypo-fractionated regimen 45gy will be given over 15 fractions
no intervention arm	first line systemic therapy	after first line systemic therapy, patients will be kept under follow up
radiotherapy arm	first line systemic therapy	after first line systemic therapy, patients will receive radiotherapy to the primary lesion, hypo-fractionated regimen 45gy will be given over 15 fractions

Primary Outcome Measures

Name	Time	Method
progression free survival	six months	time from randomization till disease progression
patients quality of life	six months	using the European Organization for Research and Treatment of Cancer core quality of life questionnaire, the EORTC QLQ-C30

Secondary Outcome Measures

Name	Time	Method
patients toxicity	six months	number of participants suffer of different toxicity grades according to Common toxicity criteria of adverse events
overall survival	six months	time from randomization till death from any cause
patients pattern of failure	six months	Number of Participants suffer of disease progression in the primary site vs other newly developed sites

Trial Locations

Locations (1)

Medicine; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt