Standard of Care Lifestyle Support for Stage III NSCLC Patients

Non Small Cell Lung Cancer Clinical Trial

— PERCUSSION  

Official title:

Improving Standard of Care Lifestyle Support for Stage III NSCLC Cancer Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05287971
• Other study ID #: PERCUSSION
• Status: Withdrawn
• Start date: August 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: August 2023
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Behavioral:
• Lifestyle advice
Patients will receive lifestyle advice regarding nutricion and exercise and will be monitored with regard to exercise and vital signs.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance	Compliance to CCRT and durvalumab treatment	12 months
Secondary	Percentage adhering advice	Improving standard of care lifestyle support by measuring % patients successfully adhering to the dietary, exercise, smoking advice	12 months
Secondary	Perctenage use of watch	Improving standard of care lifestyle support by measuring % use of the watch (and app)	12 months
Secondary	Percentage dysphagia	Improving standard of care lifestyle support by measuring % grade 3 dysphagia and odynophagia	12 months
Secondary	Percentage dyspnea	Improving standard of care lifestyle support by measuring % grade 2 dyspnea	12 months
Secondary	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
Secondary	Standard of care lifestyle support	Measuring match between lifestyle advice and personal circumstances by questionnaire	12 months
Secondary	Barriers	Measuring adherence of barriers and facilitators in lifestyle support by questionnaire	12 months
Secondary	Proton/photon	Improving standard of care lifestyle support by measuring the difference between proton and photon therapy i the above mentioned outcome	12 months
Secondary	Durvalumab	Improving standard of care lifestyle support by measuring % patients receiving durvalumab	12 months
Secondary	Quality of life questionnaire	Improving standard of care lifestyle support by measuring the quality of life by EORTC QLQ-C30/-LC13	12 months