By an early-initiated personal, supportive care program prevent deterioration of performance status (=WHO 0 or 1) in at least 90% of patients with NSCLC stage III, as determined by the patient itself, at the start of immunotherapy.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sustained good performance status (=WHO 0 or 1) in at least 90% of the
patients, as determined by the patient itself, at the start of immunotherapy.
Secondary outcome
- % patients successfully adhering to the dietary, exercise, smoking advice
- % grade 3 dysphagia and odynophagia
- % grade 2 dyspnea
- % hospitalization for (treatment-related) complications (from start until 6
weeks after radiotherapy)
- Difference between proton and photon therapy
- % patients receiving durvalumab
- Quality of life
Background summary
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 5-year overall survival
rates (42.9 % vs 33.4%). This tri-modal therapy has become the new standard of
care. Unfortunately, the tri-modal therapy causes frequently adverse events
such as fatigue, and to a much lesser degree cough, dyspnea and pneumonitis
(3), resulting in treatment cessation in 15% - 53% of the patients. 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 to handle the burden of the full treatment
regimen.
Study objective
By an early-initiated personal, supportive care program prevent deterioration
of performance status (=WHO 0 or 1) in at least 90% of patients with NSCLC
stage III, as determined by the patient itself, at the start of immunotherapy.
Study design
Prospective, non-randomized observational non-interventional clinical trial.
Patients will receive standard of care in combination with a supportive,
personalized program regarding smoking, diet and exercise.
Study burden and risks
The risks of participating in the trial for the patients are very small.
The burden consists mainly of the time it will cost patients with filling out
questionnaires and dietary- and physical activity records.
During treatment, patients* physical condition may improve due to the lifestyle
intervention, making it easier to undergo the radiation and immunotherapy
treatment.
Dr. Tanslaan 12
Maastricht 6229ET
NL
Dr. Tanslaan 12
Maastricht 6229ET
NL
Listed location countries
Age
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:
o Concurrent chemotherapy and radiotherapy with photons (60 Gy in 30 fractions
of 2 Gy) followed by durvalumab in patients with stage III NSCLC
o Concurrent chemotherapy and radiotherapy with protons (60 Gy in 30 fractions
of 2 Gy) followed by durvalumab in patients with stage III NSCLC
• Is 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 malignancies treated within 2 years before inclusion in the present
study, except for any in situ cancer or non-melanoma skin cancer when radically
treated
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05287971 |
| CCMO | NL81220.096.23 |