Non Small Cell Lung CancerPERCUSSIONNCT05287971
Standard of Care Lifestyle Support for Stage III NSCLC Patients
An observational study of Non Small Cell Lung Cancer, run by Maastricht Radiation Oncology.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Lifestyle advice
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Being tested
- Lifestyle advice
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle adviceBehavioural
Patients will receive lifestyle advice regarding nutricion and exercise and will be monitored with regard to exercise and vital signs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
Compliance to CCRT and durvalumab treatment
Measured: 12 months
Secondary outcomes (10)
Percentage adhering advice
Improving standard of care lifestyle support by measuring % patients successfully adhering to the dietary, exercise, smoking advice
Measured: 12 months
Perctenage use of watch
Improving standard of care lifestyle support by measuring % use of the watch (and app)
Measured: 12 months
Percentage dysphagia
Improving standard of care lifestyle support by measuring % grade 3 dysphagia and odynophagia
Measured: 12 months
Percentage dyspnea
Improving standard of care lifestyle support by measuring % grade 2 dyspnea
Measured: 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)
Measured: 12 months
Standard of care lifestyle support
Measuring match between lifestyle advice and personal circumstances by questionnaire
Measured: 12 months
Barriers
Measuring adherence of barriers and facilitators in lifestyle support by questionnaire
Measured: 12 months
Proton/photon
Improving standard of care lifestyle support by measuring the difference between proton and photon therapy i the above mentioned outcome
Measured: 12 months
Durvalumab
Improving standard of care lifestyle support by measuring % patients receiving durvalumab
Measured: 12 months
Quality of life questionnaire
Improving standard of care lifestyle support by measuring the quality of life by EORTC QLQ-C30/-LC13
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start1 Aug 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2025 (estimated)
Why it stopped: Never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk De Ruysscher, MD, PhD, Principal investigator, MaastroKaren Zegers, MD, PhD, Principal investigator, MaastroLizza Hendriks, MD, PhD, Principal investigator, Maastricht University Hospital (MUMC+)Cheryl Roumen, PhD, Study director, Maastro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287971
- Sponsor's protocol ID
- PERCUSSION
- Acronym
- PERCUSSION
- Status last verified
- Aug 2023
- First submitted
- 22 Feb 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Standard of Care Lifestyle Support for Stage III NSCLC Cancer Patients
- ClinicalTrials.gov ID
- NCT05287971
- Acronym / sponsor ID
- PERCUSSION / PERCUSSION
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
- Able and willing to comply with all trial requirements
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle advicePatients will receive lifestyle advice regarding nutricion and exercise and will be monitored with regard to exercise and vital signs. | Behavioural | – |
Primary outcome
Compliance
Time frame: 12 months
Compliance to CCRT and durvalumab treatment
10 secondary outcomes
Percentage adhering advice
Time frame: 12 months
Perctenage use of watch
Time frame: 12 months
Percentage dysphagia
Time frame: 12 months
Percentage dyspnea
Time frame: 12 months
Percentage hospitalization
Time frame: 12 months
Standard of care lifestyle support
Time frame: 12 months
Barriers
Time frame: 12 months
Proton/photon
Time frame: 12 months
Durvalumab
Time frame: 12 months
Quality of life questionnaire
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk De Ruysscher, MD, PhD principal investigator
Maastro
Karen Zegers, MD, PhD principal investigator
Maastro
Lizza Hendriks, MD, PhD principal investigator
Maastricht University Hospital (MUMC+)
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Maastricht Radiation Oncology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.