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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04776083

Enrollment

Registered

2021-03-01

Start date

2020-09-25

Completion date

2023-11-25

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

bronchogenic cancer, lung cancer

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.

Interventions

DRUGfirst line systemic therapy

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

RADIATION3D radiotherapy or IMRT

Hypo-fractionated radiotherapy to the primary lesion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026