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

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

Study Overview

• Status: Completed
• Conditions: Radiation Therapy; Non-Small Cell Carcinoma of Lung, TNM Stage 4
• Intervention / Treatment: Drug: first line systemic therapy; Radiation: 3D radiotherapy or IMRT

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt, 32511
      • Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: first line systemic therapy; first line systemic therapy according to the genetic mutation 0f the patient; Radiation: 3D radiotherapy or IMRT; Hypo-fractionated radiotherapy to the primary lesion
Active Comparator: no intervention arm; after first line systemic therapy, patients will be kept under follow up	Drug: first line systemic therapy; first line systemic therapy according to the genetic mutation 0f the patient

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Study Chair: Eman AR Tawfeek, MD, Menoufia University; Study Chair: Enas AB Elkhouly, MD, Menoufia University; Study Chair: Reham A Abdel Aziz, MD, Menoufia University; Principal Investigator: Yostena Mekhail, M.Sc, Menoufia University; Study Chair: Ahmed Sohaib, MD, Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Actual): November 25, 2023
• Study Completion (Actual): November 25, 2023

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 25, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: lung cancer; bronchogenic cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: after publishing the primary results. and if further publications will be based on these data, should add us as co investigators.
• IPD Sharing Time Frame: after publishing the primary results.
• IPD Sharing Access Criteria: via mail contact to the primary investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No