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Improving Standard of Care lifestyle support for stage III NSCLC cancer patients

Improving Standard of Care lifestyle support for stage III NSCLC cancer patients - PERCUSSION

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53651
Enrollment
20
Registered
2023-07-18
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

None listed

Sponsors

MAASTRO clinic
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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: 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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- % 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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)