Non-Small Cell Carcinoma of Lung, TNM Stage 4Phase 3NCT04776083
Radiotherapy to the Primary in Metastatic Non-small Cell Lung Cancer Patients
A Phase 3 study testing first line systemic therapy and 3D radiotherapy or IMRT in people with Non-Small Cell Carcinoma of Lung, TNM Stage 4 and Radiation Therapy, run by Menoufia University at 1 site in Egypt.
Trial summary
study the effect of radiotherapy to the primary lesion after first line systemic therapy in metastatic non-small cell lung cancer patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-Small Cell Carcinoma of Lung, TNM Stage 4, Radiation Therapy
- What is being tested?
- first line systemic therapy and 3D radiotherapy or IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Sep 2020to 25 Nov 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- first line systemic therapy, 3D radiotherapy or IMRT
- Keywords
- bronchogenic cancer, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first line systemic therapyDrug
first line systemic therapy according to the genetic mutation 0f the patient
3D radiotherapy or IMRTRadiation
Hypo-fractionated radiotherapy to the primary lesion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: first line systemic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
time from randomization till disease progression
Measured: 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
Measured: six months
Secondary outcomes (3)
overall survival
time from randomization till death from any cause
Measured: six months
patients toxicity
number of participants suffer of different toxicity grades according to Common toxicity criteria of adverse events
Measured: six months
patients pattern of failure
Number of Participants suffer of disease progression in the primary site vs other newly developed sites
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start25 Sep 2020
- Primary completion25 Nov 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Carcinoma of Lung, TNM Stage 4Studies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yostena nagy kamel mekhail, Menoufia University
- Investigators
- Yostena Mekhail, M.Sc, Principal investigator, Menoufia UniversityEman AR Tawfeek, MD, Study chair, Menoufia UniversityEnas AB Elkhouly, MD, Study chair, Menoufia UniversityReham A Abdel Aziz, MD, Study chair, Menoufia UniversityAhmed Sohaib, MD, Study chair, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776083
- Sponsor's protocol ID
- 174 Lung Cancer
- Status last verified
- Sep 2024
- First submitted
- 25 Feb 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after publishing the primary results. and if further publications will be based on these data, should add us as co investigators.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Radiotherapy to the Primary Lesion in Metastatic Non-small Cell Lung Cancer Patients After First Line Systemic Therapy
- ClinicalTrials.gov ID
- NCT04776083
- Acronym / sponsor ID
- 174 Lung Cancer
- Keywords
- bronchogenic cancer, lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiotherapy arm | Experimental | Drug: first line systemic therapy, Radiation: 3D radiotherapy or IMRTafter first line systemic therapy, patients will receive radiotherapy to the primary lesion, hypo-fractionated regimen 45gy will be given over 15 fractions |
| no intervention arm | Active comparator | Drug: first line systemic therapyafter first line systemic therapy, patients will be kept under follow up |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| first line systemic therapyfirst line systemic therapy according to the genetic mutation 0f the patient | Drug | no intervention arm, radiotherapy arm |
| 3D radiotherapy or IMRTHypo-fractionated radiotherapy to the primary lesion | Radiation | radiotherapy arm |
Primary outcome
progression free survival
Time frame: six months
time from randomization till disease progression
patients quality of life
Time frame: six months
using the European Organization for Research and Treatment of Cancer core quality of life questionnaire, the EORTC QLQ-C30
3 secondary outcomes
overall survival
Time frame: six months
patients toxicity
Time frame: six months
patients pattern of failure
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. after publishing the primary results. and if further publications will be based on these data, should add us as co investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yostena Mekhail, M.Sc principal investigator
Menoufia University
Eman AR Tawfeek, MD study chair
Menoufia University
Enas AB Elkhouly, MD study chair
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing first line systemic therapy and 3D radiotherapy or IMRT in people with Non-Small Cell Carcinoma of Lung, TNM Stage 4 and Radiation Therapy, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.