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

NCT04776083 | Completed Phase 3 DMC

• 1 other identifier: 174 Lung Cancer
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

bronchogenic cancer; lung cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• overall survival

  six months

• patients toxicity

  six months

• patients pattern of failure

  six months

Study Arms (2)

radiotherapy arm

EXPERIMENTAL

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; Radiation: 3D radiotherapy or IMRT

no intervention arm

ACTIVE COMPARATOR

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

Drug: first line systemic therapy

Interventions

first line systemic therapy DRUG

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

no intervention arm; radiotherapy arm

3D radiotherapy or IMRT RADIATION

Hypo-fractionated radiotherapy to the primary lesion

radiotherapy arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Medicine

Shibīn al Kawm, Menoufia, 32511, Egypt

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Yostena Mekhail, M.Sc

  Menoufia University

  PRINCIPAL INVESTIGATOR

• Eman AR Tawfeek, MD

  Menoufia University

  STUDY CHAIR

• Enas AB Elkhouly, MD

  Menoufia University

  STUDY CHAIR

• Reham A Abdel Aziz, MD

  Menoufia University

  STUDY CHAIR

• Ahmed Sohaib, MD

  Menoufia University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: September 25, 2020
• Primary Completion: November 25, 2023
• Study Completion: November 25, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after publishing the primary results.
• Access Criteria: via mail contact to the primary investigator

Locations

EG (1)