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

Primary Purpose

Radiotherapy, Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Thoracic radiotherapy

About this trial

This is an interventional treatment trial for Radiotherapy focused on measuring NSCLC, Radiotherapy, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Oncology, Norrlands UniversitetssjukhusRecruiting
Department of Oncology, Karolinska University Hospital
Department of Oncology, Sahlgrenska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

A: Standard of care

B: Thoracic radiotherapy

Arm Description

Normal standard of care and follow-up.

Addition of thoracic radiotherapy to 36 Gy after medical treatment.

Outcomes

Primary Outcome Measures

Difference in quality of life

LCSS, lung cancer symptom scale. A scale from zero to one-hundred, higher number indicate worse symptoms.

Secondary Outcome Measures

Overall survival

From randomization

Progression free survival

From randomization

Toxicity of esophagitis, pneumonitis, dyspnea, fatigue, cough

CTC (common toxicity criteria) version 4.0. Esophagitis, pneumonitis, dyspnea, fatigue, cough, worst grade.

Full Information

NCT ID

NCT04530708

First Posted

March 27, 2020

Last Updated

August 25, 2020

Sponsor

Swedish Lung Cancer Study Group

1. Study Identification

Unique Protocol Identification Number

NCT04530708

Brief Title

Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC

Acronym

MARS

Official Title

Multicentre Phase III Study: Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2017 (Actual)

Primary Completion Date

February 1, 2024 (Anticipated)

Study Completion Date

February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Swedish Lung Cancer Study Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

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

Radiotherapy, Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Quality of Life

Keywords

NSCLC, Radiotherapy, Quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Multicentre randomized phase 3 trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

A: Standard of care

Arm Type

No Intervention

Arm Description

Normal standard of care and follow-up.

Arm Title

B: Thoracic radiotherapy

Arm Type

Experimental

Arm Description

Addition of thoracic radiotherapy to 36 Gy after medical treatment.

Intervention Type

Radiation

Intervention Name(s)

Thoracic radiotherapy

Intervention Description

36 Gy to the primary lung tumor and present mediastinal node metastases after three months of medical treatment.

Primary Outcome Measure Information:

Title

Difference in quality of life

Description

LCSS, lung cancer symptom scale. A scale from zero to one-hundred, higher number indicate worse symptoms.

Time Frame

Three months after randomization

Secondary Outcome Measure Information:

Title

Overall survival

Description

From randomization

Time Frame

24 months

Title

Progression free survival

Description

From randomization

Time Frame

24 months

Title

Toxicity of esophagitis, pneumonitis, dyspnea, fatigue, cough

Description

CTC (common toxicity criteria) version 4.0. Esophagitis, pneumonitis, dyspnea, fatigue, cough, worst grade.

Time Frame

During follow-up , up to 24 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jan Nyman, Ass.prof.

Phone

0046313421000

Ext

27927

jan.nyman@oncology.gu.se

First Name & Middle Initial & Last Name or Official Title & Degree

Andreas Hallqvist, MD, PhD

Phone

0046739845114

andreas.hallqvist@vgregion.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Nyman, Ass.prof

Organizational Affiliation

Sahlgrenska University Hospital, Sweden

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thomas Björk-Eriksson, Prof.

Organizational Affiliation

Regionalt Cancercentrum Väst

Official's Role

Study Director

Facility Information:

Facility Name

Department of Oncology, Norrlands Universitetssjukhus

City

Umeå

State/Province

Norrland

ZIP/Postal Code

901 85

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mikael Johansson, MD PhD

Phone

0046703711414

mikael.johansson@onkologi.umu.se

First Name & Middle Initial & Last Name & Degree

Mikael Johansson, MD PhD

Facility Name

Department of Oncology, Karolinska University Hospital

City

Stockholm

State/Province

Stockholm County

ZIP/Postal Code

171 76

Country

Sweden

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Signe Friesland, MD PhD

signe.friesland@sll.se

First Name & Middle Initial & Last Name & Degree

Gunnar Wagenius, MD PhD

gunnar.wagenius@sll.se

First Name & Middle Initial & Last Name & Degree

Signe Friesland, MD PhD

First Name & Middle Initial & Last Name & Degree

Gunnar Wagenius, MD PhD

Facility Name

Department of Oncology, Sahlgrenska University Hospital

City

Gothenburg

State/Province

Västra Götaland

ZIP/Postal Code

413 45

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jan Nyman, Ass prof

Phone

0046313427927

jan.nyman@oncology.gu.se

First Name & Middle Initial & Last Name & Degree

Bengt Bergman, Ass.prof.

Phone

0046706187880

bengt.bergman@vgregion.se

First Name & Middle Initial & Last Name & Degree

Andreas Hallqvist, MD PhD

First Name & Middle Initial & Last Name & Degree

Jan Rzepecki, MD

First Name & Middle Initial & Last Name & Degree

Hillevi Rylander, MD

First Name & Middle Initial & Last Name & Degree

Hedda Haugen, MD PhD

First Name & Middle Initial & Last Name & Degree

Erik Lundin, MD

First Name & Middle Initial & Last Name & Degree

Mihalj Seke, MD

First Name & Middle Initial & Last Name & Degree

Jan Nyman, Ass prof

First Name & Middle Initial & Last Name & Degree

Kristina Lamberg, MD

First Name & Middle Initial & Last Name & Degree

Hirsh Koyi, MD PhD

12. IPD Sharing Statement

Learn more about this trial

Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC

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