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

Withdrawn

Conditions: Lung cancer
10038666

Registration Number: NL-OMON53651

Lead Sponsor: MAASTRO clinic

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sustained good performance status (=WHO 0 or 1) in at least 90% of the<br /><br>patients, as determined by the patient itself, at the start of immunotherapy. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- % patients successfully adhering to the dietary, exercise, smoking advice<br /><br>- % grade 3 dysphagia and odynophagia<br /><br>- % grade 2 dyspnea<br /><br>- % hospitalization for (treatment-related) complications (from start until 6<br /><br>weeks after radiotherapy)<br /><br>- Difference between proton and photon therapy<br /><br>- % patients receiving durvalumab<br /><br>- Quality of life </p><br>