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

Radiation Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04776083
• Other study ID #: 174
• Status: Completed
• Phase: Phase 3
• Start date: September 25, 2020
• Est. completion date: November 25, 2023

Study information

• Verified date: December 2023
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 25, 2023
• Est. primary completion date: November 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Egypt	Medicine	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

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