RadiotherapyMARSNCT04530708
Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC
A study testing Thoracic radiotherapy in people with Radiotherapy and Non Small Cell Lung Cancer, run by Swedish Lung Cancer Study Group at 3 sites in Sweden.
Trial summary
The hypothesis for this study is that addition of a moderate dose of radiotherapy to the primary tumor and mediastinal nodes after three months of medical treatment could reduce the tumor burden, partly as an abscopal effect, and thereby improving quality of life and possible also prolonging survival for stage IV… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy, Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- What is being tested?
- Thoracic radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Feb 2017to 1 Feb 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological confirmed non-small cell lung cancer (NSCLC)
- Stage IV disease
- Previously untreated disease (before first line treatment)
- No symptomatic brain metastases
- Performance status (WHO) 0-2
- FEV1 (forced expiratory volume one second) ≥ 1 L or >40% of predicted
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- Written informed consent
- Life expectancy ≥ 12 weeks
- Platelet count ≥ 100,00/mm3
- Hemoglobin ≥ 10 g/dl
- WBC (White blod cells) ≥ 3,000/mm3
- Kidney function allowing chemotherapy
- Patients scheduled for standard platinum based chemotherapy, chemo-immunotherapy or immunotherapy
- Willing and able to comply with study treatment
Who cannot join
- Requirement for daily supplemental oxygen
- Second primary malignancy within 3 years, except for any of the following which can be included even if diagnosed within the past 3 years: Carcinoma in situ of the cervix, nonmelanoma skin cancer, history of low-grade (Gleason score ≤ 6) localized prostate cancer, definitely treated stage I breast cancer, other malignancy that was diagnosed and definitely treated ≥ 3 years ago with no subsequent evidence of recurrence
- Concurrent severe and/or uncontrolled medical condition, including any of the following:
- Angina pectoris
- Congestive heart failure within the past 3 months, unless LVEF (left ventricular ejection fraction) > 40%
- Myocardial infarction within the past 6 months
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- Clinically significant infection
- Psychiatric illness or social situation that would limit compliance with study requirements
- EGFR (epidermal growth factor receptor) mutation or ALK (anaplastic lymphoma kinas) - rearrangement detected
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites, 3 recruiting
- Recruiting
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, 413 45
Jan Nyman, Ass prof, 0046313427927, jan.nyman@oncology.gu.se
Bengt Bergman, Ass.prof., 0046706187880, bengt.bergman@vgregion.se
- Not yet recruiting
Department of Oncology, Karolinska University Hospital
Stockholm, Stockholm County, 171 76
Signe Friesland, MD PhD, signe.friesland@sll.se
Gunnar Wagenius, MD PhD, gunnar.wagenius@sll.se
- Recruiting
Department of Oncology, Norrlands Universitetssjukhus
Umeå, Norrland, 901 85
Mikael Johansson, MD PhD, 0046703711414, mikael.johansson@onkologi.umu.se
Mikael Johansson, MD PhD
About this study
Official title: Multicentre Phase III Study: Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC
The hypothesis for this study is that addition of a moderate dose of radiotherapy to the primary tumor and mediastinal nodes after three months of medical treatment could reduce the tumor burden, partly as an abscopal effect, and thereby improving quality of life and possible also prolonging survival for stage IV NSCLC.
Read the detailed description
Primary objective: To assess whether the addition of radiotherapy to the remaining thoracic tumor burden following standard medical treatment results in a superior quality of life measured with lung cancer symptom scale (LCSS) in patients with stage IV non-small cell lung cancer. The comparison will be made at three months after randomization.
Secondary objectives: Overall survival, progression-free survival, toxicity and longitudinal quality of life measurements.
Design: Multicentre, randomized, phase III trial. Patients will be registered for the study up-front but randomization will be performed after evaluation of response, three months after initiating medical treatment with chemotherapy/ chemo-immunotherapy or immunotherapy. Randomization will be to thoracic radiotherapy or follow-up (1:1).
- Conditions
- Radiotherapy, Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Quality of Life
- Being tested
- Thoracic radiotherapy
- Keywords
- NSCLC, Radiotherapy, Quality of life
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic radiotherapyRadiation
36 Gy to the primary lung tumor and present mediastinal node metastases after three months of medical treatment.
| Study group | Role | What they receive |
|---|---|---|
| A: Standard of care | No intervention | Normal standard of care and follow-up. |
| B: Thoracic radiotherapy | Experimental | Addition of thoracic radiotherapy to 36 Gy after medical treatment. Receives: Radiation: Thoracic radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in quality of life
LCSS, lung cancer symptom scale. A scale from zero to one-hundred, higher number indicate worse symptoms.
Measured: Three months after randomization
Secondary outcomes (3)
Overall survival
From randomization
Measured: 24 months
Progression free survival
From randomization
Measured: 24 months
Toxicity of esophagitis, pneumonitis, dyspnea, fatigue, cough
CTC (common toxicity criteria) version 4.0. Esophagitis, pneumonitis, dyspnea, fatigue, cough, worst grade.
Measured: During follow-up , up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Feb 2017
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre randomized phase 3 trial
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swedish Lung Cancer Study Group
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group
- Investigators
- Jan Nyman, Ass.prof, Principal investigator, Sahlgrenska University HospitalThomas Björk-Eriksson, Prof., Study director, Regionalt Cancercentrum Väst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530708
- Sponsor's protocol ID
- MARS
- Acronym
- MARS
- Status last verified
- Aug 2020
- First submitted
- 27 Mar 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Phase III Study: Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC
- ClinicalTrials.gov ID
- NCT04530708
- Acronym / sponsor ID
- MARS / MARS
- Conditions
- Radiotherapy, Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Quality of Life
- Keywords
- NSCLC, Radiotherapy, Quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Swedish Lung Cancer Study GroupResearch network
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 28 Aug 2020 (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.
The hypothesis for this study is that addition of a moderate dose of radiotherapy to the primary tumor and mediastinal nodes after three months of medical treatment could reduce the tumor burden, partly as an abscopal effect, and thereby improving quality of life and possible also prolonging survival for stage IV NSCLC.
Detailed description
Primary objective: To assess whether the addition of radiotherapy to the remaining thoracic tumor burden following standard medical treatment results in a superior quality of life measured with lung cancer symptom scale (LCSS) in patients with stage IV non-small cell lung cancer. The comparison will be made at three months after randomization.
Secondary objectives: Overall survival, progression-free survival, toxicity and longitudinal quality of life measurements.
Design: Multicentre, randomized, phase III trial. Patients will be registered for the study up-front but randomization will be performed after evaluation of response, three months after initiating medical treatment with chemotherapy/ chemo-immunotherapy or immunotherapy. Randomization will be to thoracic radiotherapy or follow-up (1:1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentre randomized phase 3 trial
| Arm | Type | Receives |
|---|---|---|
| A: Standard of care | No intervention | –Normal standard of care and follow-up. |
| B: Thoracic radiotherapy | Experimental | Radiation: Thoracic radiotherapyAddition of thoracic radiotherapy to 36 Gy after medical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histological or cytological confirmed non-small cell lung cancer (NSCLC)
- Stage IV disease
- Previously untreated disease (before first line treatment)
- No symptomatic brain metastases
- Performance status (WHO) 0-2
Key exclusion criteria (9 listed)
- Requirement for daily supplemental oxygen
- Second primary malignancy within 3 years, except for any of the following which can be included even if diagnosed within the past 3 years: Carcinoma in situ of the cervix, nonmelanoma skin cancer, history of low-grade (Gleason score ≤ 6) localized prostate cancer, definitely treated stage I breast cancer, other malignancy that was diagnosed and definitely treated ≥ 3 years ago with no subsequent evidence of recurrence
- Concurrent severe and/or uncontrolled medical condition, including any of the following:
- Angina pectoris
- Congestive heart failure within the past 3 months, unless LVEF (left ventricular ejection fraction) > 40%
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 |
|---|---|---|
| Thoracic radiotherapy36 Gy to the primary lung tumor and present mediastinal node metastases after three months of medical treatment. | Radiation | B: Thoracic radiotherapy |
Primary outcome
Difference in quality of life
Time frame: Three months after randomization
LCSS, lung cancer symptom scale. A scale from zero to one-hundred, higher number indicate worse symptoms.
3 secondary outcomes
Overall survival
Time frame: 24 months
Progression free survival
Time frame: 24 months
Toxicity of esophagitis, pneumonitis, dyspnea, fatigue, cough
Time frame: During follow-up , up to 24 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
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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.
Jan Nyman, Ass.prof principal investigator
Sahlgrenska University Hospital
Thomas Björk-Eriksson, Prof. study director
Regionalt Cancercentrum Väst
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic radiotherapy in people with Radiotherapy and Non Small Cell Lung Cancer, run by Swedish Lung Cancer Study Group at 3 sites in Sweden.
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 14 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Nyman, Ass.prof. (0046313421000 ext. 27927, jan.nyman@oncology.gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in quality of life (time frame: Three months after randomization). 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 28 Aug 2020.