Standard of Care Lifestyle Support for Stage III NSCLC Patients

NCT05287971 | Withdrawn

• 1 other identifier: PERCUSSION
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Compliance

  Compliance to CCRT and durvalumab treatment

  12 months

Secondary Outcomes (10)

• Percentage adhering advice

  12 months

• Perctenage use of watch

  12 months

• Percentage dysphagia

  12 months

• Percentage dyspnea

  12 months

• Percentage hospitalization

  12 months

Interventions

Lifestyle advice BEHAVIORAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dirk De Ruysscher, MD, PhD

  Maastro

  PRINCIPAL INVESTIGATOR

• Karen Zegers, MD, PhD

  Maastro

  PRINCIPAL INVESTIGATOR

• Lizza Hendriks, MD, PhD

  Maastricht University Hospital (MUMC+)

  PRINCIPAL INVESTIGATOR

• Cheryl Roumen, PhD

  Maastro

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 18, 2022
• Study Start: August 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share