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

Menoufia University

Status and phase: Completed; Phase 3

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

Treatments: Radiation: 3D radiotherapy or IMRT; Drug: first line systemic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04776083

174 Lung Cancer

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

radiotherapy arm

Experimental group

Description:

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

Treatment:

Drug: first line systemic therapy

Radiation: 3D radiotherapy or IMRT

no intervention arm

Active Comparator group

Description:

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

Treatment:

Drug: first line systemic therapy