An observational study in Non Small Cell Lung Cancer, sponsored by Maastricht Radiation Oncology. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by Maastricht Radiation Oncology · Observational
Offering an early-initiated supportive care program to stage III NSCLC patients to prevent deterioration of performance status and increase compliance of patients that complete chemoradiation as well as the patients receiving 12 months of durvalumab.
In inoperable Stage III Non-Small Cell Lung Cancer (NSCLC), consolidation immune checkpoint inhibition with the PD-L1 inhibitor durvalumab, given within 6 weeks after completion of concurrent platinum-based chemoradiotherapy (CCRT) for 12 months results in remarkable improvement of 3-year overall survival rates (57% vs 43.5%). This tri-modal therapy has become the new standard of care. Unfortunately, the tri-modal therapy frequently causes adverse events such as fatigue and, to a much lesser degree, cough, dyspnea and pneumonitis, resulting in treatment cessation in 15% - 53% of the patients (15%) (53%). For the most optimal overall survival (OS) and disease-free survival (DFS), compliance to the full treatment regimen, i.e. in the ideal situation 100% of patients completing their full course of CCRT and receiving durvalumab for one year, is expected to have significant and relevant beneficial effects. Optimizing patients' fitness is essential in order to handle the tough full treatment regimen.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →Maastricht Radiation Oncology is the lead sponsor of 104 studies on the registry; 9 are open to participants now.
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Patients with stage III NSCLC who are eligible for curative intent concurrent chemotherapy and radiotherapy as well as willing to adhere to the study protocol will be enrolled in the study. They receive standard radiotherapy (60 Gy in 30 fractions of 2 Gy) with photons (group 1) or protons (group 2) according to the standard of care. Eligible patients will thereafter receive standard durvalumab immune therapy for 12 months. Eligibility criteria for this study are therefore similar to those for standard of care treatment.
Scheduled to receive one of the following two therapeutic strategies:
Exclusion Criteria:
Patients will receive lifestyle advice regarding nutricion and exercise and will be monitored with regard to exercise and vital signs.
Compliance
Compliance to CCRT and durvalumab treatment
Time frame: 12 months
Percentage adhering advice
Improving standard of care lifestyle support by measuring % patients successfully adhering to the dietary, exercise, smoking advice
Time frame: 12 months
Perctenage use of watch
Improving standard of care lifestyle support by measuring % use of the watch (and app)
Time frame: 12 months
Percentage dysphagia
Improving standard of care lifestyle support by measuring % grade 3 dysphagia and odynophagia
Time frame: 12 months
Percentage dyspnea
Improving standard of care lifestyle support by measuring % grade 2 dyspnea
Time frame: 12 months
Percentage hospitalization
Improving standard of care lifestyle support by measuring % hospitalization for (treatment-related) complications + specification (from start until 6 weeks after radiotherapy)
Time frame: 12 months
Standard of care lifestyle support
Measuring match between lifestyle advice and personal circumstances by questionnaire
Time frame: 12 months
Barriers
Measuring adherence of barriers and facilitators in lifestyle support by questionnaire
Time frame: 12 months
Proton/photon
Improving standard of care lifestyle support by measuring the difference between proton and photon therapy i the above mentioned outcome
Time frame: 12 months
Durvalumab
Improving standard of care lifestyle support by measuring % patients receiving durvalumab
Time frame: 12 months
Quality of life questionnaire
Improving standard of care lifestyle support by measuring the quality of life by EORTC QLQ-C30/-LC13
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Maastricht Radiation Oncology