Clinical trial NCT05287971: Standard of Care Lifestyle Support for Stage III NSCLC Patients
Official title: Improving Standard of Care Lifestyle Support for Stage III NSCLC Cancer Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility 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:

  * Concurrent chemotherapy and radiotherapy with photons (60 Gy in 30 fractions of 2 Gy) followed by durvalumab in patients with stage III NSCLC
  * Concurrent chemotherapy and radiotherapy with protons (60 Gy in 30 fractions of 2 Gy) followed by durvalumab in patients with stage III NSCLC
* Able and willing to comply with all trial requirements

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 malignancy treated with chemotherapy, immune therapy or radiotherapy (irrespective of when this happened)
* Previous malignancies treated with surgery only are allowed if 2 years or more before inclusion in the present study

Primary outcomes:
measure: Compliance
timeFrame: 12 months
Secondary outcomes:
measure: Percentage adhering advice
timeFrame: 12 months
measure: Perctenage use of watch
timeFrame: 12 months
measure: Percentage dysphagia
timeFrame: 12 months
measure: Percentage dyspnea
timeFrame: 12 months
measure: Percentage hospitalization
timeFrame: 12 months
measure: Standard of care lifestyle support
timeFrame: 12 months
measure: Barriers
timeFrame: 12 months
measure: Proton/photon
timeFrame: 12 months
measure: Durvalumab
timeFrame: 12 months
measure: Quality of life questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Maastro
name: Dirk De Ruysscher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastro
name: Karen Zegers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University Hospital (MUMC+)
name: Lizza Hendriks, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastro
name: Cheryl Roumen, PhD
role: STUDY_DIRECTOR
References: