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

Who is this study for? Patients with stage IV NSCLC
What treatments are being studied? Thoracic radiotherapy
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Department of Oncology, Sahlgrenska University Hospital
RECRUITING
Gothenburg
Department of Oncology, Karolinska University Hospital
NOT_YET_RECRUITING
Stockholm
Department of Oncology, Norrlands Universitetssjukhus
RECRUITING
Umeå
Contact Information
Primary
Jan Nyman, Ass.prof.
jan.nyman@oncology.gu.se
0046313421000
Backup
Andreas Hallqvist, MD, PhD
andreas.hallqvist@vgregion.se
0046739845114
Time Frame
Start Date: 2017-02-01
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 162
Treatments
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.
Sponsors
Leads: Swedish Lung Cancer Study Group

This content was sourced from clinicaltrials.gov