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

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

Detailed Description
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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.

Official Title
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Role of Radiotherapy to the Primary Lesion in Metastatic Non-small Cell Lung Cancer Patients After First Line Systemic Therapy

Conditions
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Non-Small Cell Carcinoma of Lung, TNM Stage 4, Radiation Therapy

Intervention / Treatment
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* Drug: first line systemic therapy
* Radiation: 3D radiotherapy or IMRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed histological diagnosis of NSCLC. Stage IV disease. Patients with P.S ≤ 2. 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: History of prior irradiation to the lung. residual Malignant pleural or pericardial effusion at randomization time. History of prior malignant tumor likely to interfere with the treatment protocol. Severe comorbidities as measured by morbidity index. Disease progression on first line systemic therapy.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiotherapy arm<br>after first line systemic therapy, patients will receive radiotherapy to the primary lesion, hypo-fractionated regimen 45gy will be given over 15 fractions | Drug: first line systemic therapy<br>* first line systemic therapy according to the genetic mutation 0f the patient<br>Radiation: 3D radiotherapy or IMRT<br>* Hypo-fractionated radiotherapy to the primary lesion<br>|
| Active Comparator: no intervention arm<br>after first line systemic therapy, patients will be kept under follow up | Drug: first line systemic therapy<br>* first line systemic therapy according to the genetic mutation 0f the patient<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchogenic cancer, lung cancer