Addition of Radiotherapy to Standard Medical Treatment for Stage IV NSCLC
NCT ID: NCT04530708
Last Updated: 2020-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
162 participants
INTERVENTIONAL
2017-02-01
2026-02-01
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A: Standard of care
Normal standard of care and follow-up.
No interventions assigned to this group
B: Thoracic radiotherapy
Addition of thoracic radiotherapy to 36 Gy after medical treatment.
Thoracic radiotherapy
36 Gy to the primary lung tumor and present mediastinal node metastases after three months of medical treatment.
Interventions
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Thoracic radiotherapy
36 Gy to the primary lung tumor and present mediastinal node metastases after three months of medical treatment.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Swedish Lung Cancer Study Group
NETWORK
Responsible Party
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Ass. Prof. Jan Nyman
Head of Swedish Lung Cancer Study Group, Ass. Prof.
Principal Investigators
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Jan Nyman, Ass.prof
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Thomas Björk-Eriksson, Prof.
Role: STUDY_DIRECTOR
Regionalt Cancercentrum Väst
Locations
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Department of Oncology, Norrlands Universitetssjukhus
Umeå, Norrland, Sweden
Department of Oncology, Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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MARS
Identifier Type: -
Identifier Source: org_study_id
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