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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle advice | Behavioral | Patients will receive lifestyle advice regarding nutricion and exercise and will be monitored with regard to exercise and vital signs. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance | Compliance to CCRT and durvalumab treatment | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage adhering advice | Improving standard of care lifestyle support by measuring % patients successfully adhering to the dietary, exercise, smoking advice | 12 months |
| Perctenage use of watch |
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Inclusion Criteria:
Pathological diagnosis of adequately staged (according to standard practice using chest-CT, FDG-PET, brain imaging MRI/CT) NSCLC
Participant is willing and able to give informed consent for participation in the trial
Aged 18 years or above
Scheduled to receive one of the following two therapeutic strategies:
Able and willing to comply with all trial requirements
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Dirk De Ruysscher, MD, PhD | Maastro | Principal Investigator |
| Karen Zegers, MD, PhD | Maastro | Principal Investigator |
| Lizza Hendriks, MD, PhD | Maastricht University Hospital (MUMC+) | Principal Investigator |
| Cheryl Roumen, PhD | Maastro | Study Director |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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Improving standard of care lifestyle support by measuring % use of the watch (and app)
| 12 months |
| Percentage dysphagia | Improving standard of care lifestyle support by measuring % grade 3 dysphagia and odynophagia | 12 months |
| Percentage dyspnea | Improving standard of care lifestyle support by measuring % grade 2 dyspnea | 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) | 12 months |
| Standard of care lifestyle support | Measuring match between lifestyle advice and personal circumstances by questionnaire | 12 months |
| Barriers | Measuring adherence of barriers and facilitators in lifestyle support by questionnaire | 12 months |
| Proton/photon | Improving standard of care lifestyle support by measuring the difference between proton and photon therapy i the above mentioned outcome | 12 months |
| Durvalumab | Improving standard of care lifestyle support by measuring % patients receiving durvalumab | 12 months |
| Quality of life questionnaire | Improving standard of care lifestyle support by measuring the quality of life by EORTC QLQ-C30/-LC13 | 12 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |