Standard of Care Lifestyle Support for Stage III NSCLC Patients

Withdrawn

• Conditions: Non Small Cell Lung Cancer

• Registration Number: NCT05287971
• Lead Sponsor: Maastricht Radiation Oncology

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.

Study Timeline

• Study First Submitted: 2022-02-22
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-18
• Status Verified: 2023-08
• Study Start: 2023-08-01
• Last Update Submitted: 2023-08-31
• Last Update Posted: 2023-09-06
• Primary Completion: 2024-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compliance	12 months	Compliance to CCRT and durvalumab treatment

Secondary Outcome Measures

Name	Time	Method
Perctenage use of watch	12 months	Improving standard of care lifestyle support by measuring % use of the watch (and app)
Percentage adhering advice	12 months	Improving standard of care lifestyle support by measuring % patients successfully adhering to the dietary, exercise, smoking advice
Percentage dysphagia	12 months	Improving standard of care lifestyle support by measuring % grade 3 dysphagia and odynophagia
Percentage dyspnea	12 months	Improving standard of care lifestyle support by measuring % grade 2 dyspnea
Standard of care lifestyle support	12 months	Measuring match between lifestyle advice and personal circumstances by questionnaire
Barriers	12 months	Measuring adherence of barriers and facilitators in lifestyle support by questionnaire
Proton/photon	12 months	Improving standard of care lifestyle support by measuring the difference between proton and photon therapy i the above mentioned outcome
Percentage hospitalization	12 months	Improving standard of care lifestyle support by measuring % hospitalization for (treatment-related) complications + specification (from start until 6 weeks after radiotherapy)
Durvalumab	12 months	Improving standard of care lifestyle support by measuring % patients receiving durvalumab
Quality of life questionnaire	12 months	Improving standard of care lifestyle support by measuring the quality of life by EORTC QLQ-C30/-LC13