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

Primary Purpose

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

Status

Active

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

first line systemic therapy

3D radiotherapy or IMRT

About this trial

This is an interventional treatment trial for Non-Small Cell Carcinoma of Lung, TNM Stage 4 focused on measuring bronchogenic cancer, lung cancer

Eligibility Criteria

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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.

Sites / Locations

Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

radiotherapy arm

no intervention arm

Arm Description

after first line systemic therapy, patients will receive radiotherapy to the primary lesion, hypo-fractionated regimen 45gy will be given over 15 fractions

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

Outcomes

Primary Outcome Measures

progression free survival

time from randomization till disease progression

patients quality of life

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

Secondary Outcome Measures

overall survival

time from randomization till death from any cause

patients toxicity

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

patients pattern of failure

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

Full Information

NCT ID

NCT04776083

First Posted

February 25, 2021

Last Updated

May 8, 2023

Sponsor

Menoufia University

1. Study Identification

Unique Protocol Identification Number

NCT04776083

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 25, 2021 (Actual)

Primary Completion Date

May 25, 2023 (Anticipated)

Study Completion Date

May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

bronchogenic cancer, lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

radiotherapy arm

Arm Type

Experimental

Arm Description

after first line systemic therapy, patients will receive radiotherapy to the primary lesion, hypo-fractionated regimen 45gy will be given over 15 fractions

Arm Title

no intervention arm

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

first line systemic therapy

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

3D radiotherapy or IMRT

Intervention Description

Hypo-fractionated radiotherapy to the primary lesion

Primary Outcome Measure Information:

Title

progression free survival

Description

time from randomization till disease progression

Time Frame

six months

Title

patients quality of life

Description

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

Time Frame

six months

Secondary Outcome Measure Information:

Title

overall survival

Description

time from randomization till death from any cause

Time Frame

six months

Title

patients toxicity

Description

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

Time Frame

six months

Title

patients pattern of failure

Description

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

Time Frame

six months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: