Prophylactic Cranial Irradiation (PCI) versus observation in radically treated patients with stage III non-small cell lung cancer: A phase III randomized study.
Recruiting
- Conditions
- on small cell lung cancer (NSCLC).Patients should either be registered after diagnosis of stage III NSCLC, when potential radical therapy is envisaged, or after radical therapy. After radical treatment, non-progressing patients will be randomized to receive PCI of no PCI.
- Registration Number
- NL-OMON25846
- Lead Sponsor
- VALT-oncology en DLCRG
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
Registration:
1. UICC stage III A or IIIB (without malignant pleural or pericardial effusion) non-small cell lung cancer (histology or cytology);
Exclusion Criteria
Registration:
1. Pregnant women are ineligible as treatment involves unforeseen risks to the participant and to the embryo or fetus;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine whether PCI decreases the proportion of patients developing symptomatic brain metastases in patients with radically treated stage III NSCLC.<br /><br>Symptomatic brain metastases are defined as a combination of at least key symptom suggesting brain metastases (signs of increased intracranial pressure, headache, nausea and vomiting, cognitive or affective disturbances, seizures and focal neurological symptoms) and MRI or CT proving the existence of brain metastasis.<br>
- Secondary Outcome Measures
Name Time Method 1. To determine the time to develop neurological symptoms (confirmed or unconfirmed by imaging);<br /><br>2. To determine the side effects and effects on the general condition of PCI with the CTCAE 3.0 scoring system, assessed by the patient;<br /> <br>3. To determine the Quality of Life (QoL) (QLQ-C30 and EuroQol 5D);<br /><br>4. To determine the effect of PCI on the overall survival;<br /><br>5. To find out whether PCI is cost-effective as opposed to observation in this setting. This part of the study will only be performed in Maastricht.