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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04776083
Other study ID # 174
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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