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Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC (MARS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04530708
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group

Study Description
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Brief 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 NSCLC.

Condition or disease Intervention/treatment Phase
Radiotherapy Non Small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Quality of Life Radiation: Thoracic radiotherapy Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicentre randomized phase 3 trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentre Phase III Study: Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
No Intervention: A: Standard of care
Normal standard of care and follow-up.
Experimental: B: Thoracic radiotherapy
Addition of thoracic radiotherapy to 36 Gy after medical treatment.
 Radiation: Thoracic radiotherapy
36 Gy to the primary lung tumor and present mediastinal node metastases after three months of medical treatment.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 24 months ]
    From randomization

  2. Progression free survival [ Time Frame: 24 months ]
    From randomization

  3. Toxicity of esophagitis, pneumonitis, dyspnea, fatigue, cough [ Time Frame: During follow-up , up to 24 months. ]
    CTC (common toxicity criteria) version 4.0. Esophagitis, pneumonitis, dyspnea, fatigue, cough, worst grade.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04530708


Contacts
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Contact: Jan Nyman, Ass.prof. 0046313421000 ext 27927 jan.nyman@oncology.gu.se
Contact: Andreas Hallqvist, MD, PhD 0046739845114 andreas.hallqvist@vgregion.se

Locations
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Sweden
Department of Oncology, Norrlands Universitetssjukhus Recruiting
Umeå, Norrland, Sweden, 901 85
Contact: Mikael Johansson, MD PhD    0046703711414    mikael.johansson@onkologi.umu.se   
Sub-Investigator: Mikael Johansson, MD PhD         
Department of Oncology, Karolinska University Hospital Not yet recruiting
Stockholm, Stockholm County, Sweden, 171 76
Contact: Signe Friesland, MD PhD       signe.friesland@sll.se   
Contact: Gunnar Wagenius, MD PhD       gunnar.wagenius@sll.se   
Principal Investigator: Signe Friesland, MD PhD         
Sub-Investigator: Gunnar Wagenius, MD PhD         
Department of Oncology, Sahlgrenska University Hospital Recruiting
Gothenburg, Västra Götaland, Sweden, 413 45
Contact: Jan Nyman, Ass prof    0046313427927    jan.nyman@oncology.gu.se   
Contact: Bengt Bergman, Ass.prof.    0046706187880    bengt.bergman@vgregion.se   
Sub-Investigator: Andreas Hallqvist, MD PhD         
Principal Investigator: Jan Rzepecki, MD         
Sub-Investigator: Hillevi Rylander, MD         
Sub-Investigator: Hedda Haugen, MD PhD         
Principal Investigator: Erik Lundin, MD         
Principal Investigator: Mihalj Seke, MD         
Principal Investigator: Jan Nyman, Ass prof         
Principal Investigator: Kristina Lamberg, MD         
Principal Investigator: Hirsh Koyi, MD PhD         
Sponsors and Collaborators
Swedish Lung Cancer Study Group
Investigators
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Principal Investigator: Jan Nyman, Ass.prof Sahlgrenska University Hospital, Sweden
Study Director: Thomas Björk-Eriksson, Prof. Regionalt Cancercentrum Väst
  Study Documents (Full-Text)

Documents provided by Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group:
Study Protocol  [PDF] October 17, 2019

More Information
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Responsible Party: Ass. Prof. Jan Nyman, Head of Swedish Lung Cancer Study Group, Ass. Prof., Swedish Lung Cancer Study Group
ClinicalTrials.gov Identifier: NCT04530708    
Other Study ID Numbers: MARS
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group:
NSCLC
Radiotherapy
Quality of life
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms