Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC

NCT04530708 | Unknown

• 1 other identifier: MARS
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

NSCLC; Radiotherapy; Quality of life

Outcome Measures

Primary Outcomes (1)

• Difference in quality of life

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

  Three months after randomization

Secondary Outcomes (3)

• Overall survival

  24 months

• Progression free survival

  24 months

• Toxicity of esophagitis, pneumonitis, dyspnea, fatigue, cough

  During follow-up , up to 24 months.

Study Arms (2)

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.

Radiation: Thoracic radiotherapy

Interventions

Thoracic radiotherapy RADIATION

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

B: Thoracic radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swedish Lung Cancer Study Group: lead

Study Sites (3)

Department of Oncology, Norrlands Universitetssjukhus

Umeå, Norrland, 901 85, Sweden

RECRUITING

Department of Oncology, Karolinska University Hospital

Stockholm, Stockholm County, 171 76, Sweden

NOT YET RECRUITING

Department of Oncology, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 413 45, Sweden

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jan Nyman, Ass.prof

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

• Thomas Björk-Eriksson, Prof.

  Regionalt Cancercentrum Väst

  STUDY DIRECTOR

Central Study Contacts

Jan Nyman, Ass.prof.

CONTACT

0046313421000; jan.nyman@oncology.gu.se

Andreas Hallqvist, MD, PhD

CONTACT

0046739845114; andreas.hallqvist@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Swedish Lung Cancer Study Group, Ass. Prof.

Model Details: Multicentre randomized phase 3 trial

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: August 28, 2020
• Study Start: February 1, 2017
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2026
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

SE (3)