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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-25

Study Completion Date

2023-11-25

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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radiotherapy arm

after first line systemic therapy, patients will receive radiotherapy to the primary lesion, hypo-fractionated regimen 45gy will be given over 15 fractions

Group Type EXPERIMENTAL

first line systemic therapy

Intervention Type DRUG

first line systemic therapy according to the genetic mutation 0f the patient

3D radiotherapy or IMRT

Intervention Type RADIATION

Hypo-fractionated radiotherapy to the primary lesion

no intervention arm

after first line systemic therapy, patients will be kept under follow up

Group Type ACTIVE_COMPARATOR

first line systemic therapy

Intervention Type DRUG

first line systemic therapy according to the genetic mutation 0f the patient

Interventions

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first line systemic therapy

first line systemic therapy according to the genetic mutation 0f the patient

Intervention Type DRUG

3D radiotherapy or IMRT

Hypo-fractionated radiotherapy to the primary lesion

Intervention Type RADIATION

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No