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

August 25, 2020 updated by: Ass. Prof. Jan Nyman, Swedish Lung Cancer Study Group

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
    • Norrland
      • Umeå, Norrland, Sweden, 901 85
        • Recruiting
        • Department of Oncology, Norrlands Universitetssjukhus
        • Contact:
        • Sub-Investigator:
          • Mikael Johansson, MD PhD
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 76
        • Not yet recruiting
        • Department of Oncology, Karolinska University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Signe Friesland, MD PhD
        • Sub-Investigator:
          • Gunnar Wagenius, MD PhD
    • Västra Götaland
      • Gothenburg, Västra Götaland, Sweden, 413 45
        • Recruiting
        • Department of Oncology, Sahlgrenska University Hospital
        • Contact:
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 24 months
From randomization
24 months
Progression free survival
Time Frame: 24 months
From randomization
24 months
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.
During follow-up , up to 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swedish Lung Cancer Study Group

Investigators

  • Principal Investigator: Jan Nyman, Ass.prof, Sahlgrenska University Hospital, Sweden
  • Study Director: Thomas Björk-Eriksson, Prof., Regionalt Cancercentrum Väst

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2026

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MARS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on Thoracic radiotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe