Standard of Care Lifestyle Support for Stage III NSCLC Patients (PERCUSSION)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Behavioral: Lifestyle advice

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 Type: Observational

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	Compliance to CCRT and durvalumab treatment	12 months

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Maastricht Radiation Oncology
• Investigators: Principal Investigator: Dirk De Ruysscher, MD, PhD, Maastro; Principal Investigator: Karen Zegers, MD, PhD, Maastro; Principal Investigator: Lizza Hendriks, MD, PhD, Maastricht University Hospital (MUMC+); Study Director: Cheryl Roumen, PhD, Maastro

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: February 22, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: PERCUSSION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No