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Completed

NCT Number: NCT04776083

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

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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Key information

Conditions

Non-Small Cell Carcinoma of Lung, TNM Stage 4 Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Radiation Therapy Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medicine

Shibīn al Kawm, Menoufia, 32511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

first line systemic therapy

Drug

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

3D radiotherapy or IMRT

Radiation

Hypo-fractionated radiotherapy to the primary lesion

Primary outcomes

  1. progression free survival

    Time frame: six months

    time from randomization till disease progression

  2. patients quality of life

    Time frame: six months

    using the European Organization for Research and Treatment of Cancer core quality of life questionnaire, the EORTC QLQ-C30

Secondary outcomes

  1. overall survival

    Time frame: six months

    time from randomization till death from any cause

  2. patients toxicity

    Time frame: six months

    number of participants suffer of different toxicity grades according to Common toxicity criteria of adverse events

  3. patients pattern of failure

    Time frame: six months

    Number of Participants suffer of disease progression in the primary site vs other newly developed sites

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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