Lung cancer Lung carcinoma Lung cancer
Conditions
Interventions
The intervention group (n = 345) consists of usual care until 3 years of follow-up (see control group) with additional whole-body 18F FDG PET/CT scans (from the skull to, at least, the midfemoral regi
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Cytological or histologically proven stage III non-small cell lung cancer before start of curative intent treatment • Treated with curative intent and started follow-up care • All adjuvant treatments are permitted as co-intervention during follow-up care • Age 18 years or older • ECOG Performance Status classification 0-2 at moment of inclusion • Written and signed informed consent by the patient or their representative (with the understanding that consent may be withdrawn by the patient or their representative at any time without consequences to future medical care)
Exclusion criteria
Exclusion criteria: • Life expectancy shorter than 6 months at the end of curative intent treatment • Evidence of recurrence after end of curative intent treatment and before randomization (4 months follow-up) • Any condition that, in the opinion of the investigator, would interfere with evaluation of the intervention or interpretation of HRQOL or other study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) will be defined as time from end of curative intent treatment until death or loss to follow-up or end of study defined as 3 years after end of curative treatment. OS will be recorded in the eCRF and cross-validated through a linkage with the National Cancer Registry. Primary analyses will be performed on an intention-to-treat basis. The secondary analyses will include per protocol analyses as well. | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrences, possible treatment after a recurrence, and event-free survival will be recorded in the eCRF, filled out by the Health Care Practitioners (HCP's) or a representative. Health-related quality of life and cost-effectiveness will be investigated at baseline and every six months until 24 months of follow-up and then yearly until three years, using the following validated questionnaires: EORTC-QLQ C30, EORTC-LC13, the PRO-CTCAE lung cancer subset, EQ-5D-5L, Medical Consumption Questionnaire (iMCQ), and the Productivity Costs Questionnaire (iPCQ). Hospital resource use will be retrieved from the EHR, and will include all diagnostic testing, hospital visits, telephone consultations, email consultations and medical use known by the hospital. The impact of the additional 18F FDG PET/CT scans in follow-up care on distress will be evaluated every six months until 24 months of follow-up and then yearly until three years, using the Cancer Worry Scale (CWS) and the Hospital Anxiety and Depression Scale (HADS). Semi-structured interviews with some patients will be conducted in the weeks after their 18F FDG PET/CT scans to to assess their experiences whether the (possible) benefits outweigh the burden of the additional 18F FDG PET/CT scan in their follow-up care (in terms of time and investment). To uniform the direction of the interviews, a semi-structured interview guide will be developed based on literature and the experience within the research team. Some hospitals will participate in obtaining blood samples to assess the beneficial value of ctDNA in the detection of recurrences. For patients in the intervention group that give additional consent for collecting blood, three cell-free DNA tubes will be collected around every follow-up scan, when the IV is inserted or at a planned blood test. The tubes will subsequently be sent to the sponsor within 24 hours, where the cell-stabilizing tubes will be centrifuged at room temperature for 10 min at 1600 g. Cell-free plasma | — |
Countries
Netherlands
Contacts
Public ContactI. Walraven
Radboud Universitair Medisch Centrum
Outcome results
None listed