Lung cancer
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
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: o Concurrent chemotherapy and radiotherapy with photons (60 Gy in 30 fractions of 2 Gy) followed by durvalumab in patients with stage III NSCLC o Concurrent chemotherapy and radiotherapy with protons (60 Gy in 30 fractions of 2 Gy) followed by durvalumab in patients with stage III NSCLC • Is able and willing to comply with all trial requirements
Exclusion criteria
Exclusion criteria: - Mixed non-small cell lung cancer with other histology such as small cell lung cancer - Not able to comply with the study protocol - Less than 18 years* old - Pregnancy or not able to comply with adequate contraception in women with child baring potential - Previous radiotherapy to the chest for benign or malignant conditions, including radiation for breast cancer - Previous malignancies treated within 2 years before inclusion in the present study, except for any in situ cancer or non-melanoma skin cancer when radically treated
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained good performance status (=WHO 0 or 1) in at least 90% of the patients, as determined by the patient itself, at the start of immunotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| - % patients successfully adhering to the dietary, exercise, smoking advice - % grade 3 dysphagia and odynophagia - % grade 2 dyspnea - % hospitalization for (treatment-related) complications (from start until 6 weeks after radiotherapy) - Difference between proton and photon therapy - % patients receiving durvalumab - Quality of life | — |
Countries
Netherlands