Standard of Care Lifestyle Support for Stage III NSCLC Patients

NCT ID: NCT05287971

Last Updated: 2023-09-06

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-05-01

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.

Conditions

Non Small Cell Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Lifestyle advice

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht Radiation Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dirk De Ruysscher, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastro

Karen Zegers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastro

Lizza Hendriks, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Hospital (MUMC+)

Cheryl Roumen, PhD

Role: STUDY_DIRECTOR

Maastro

Other Identifiers

PERCUSSION

Identifier Type: -

Identifier Source: org_study_id