Non 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.
Conditions
Interventions
Arm 1: 36 Gy in 18 fractions, 30 Gy in 12 fractions or 30 Gy in 10 fractions.
Arm 2: observation.
Sponsors
NVALT-oncology en DLCRG
Eligibility
Inclusion criteria
Inclusion criteria: Registration: 1. UICC stage III A or IIIB (without malignant pleural or pericardial effusion) non-small cell lung cancer (histology or cytology); 2. Whole body FDG-PET-scan before the start of therapy available: No distant metastases; 3. CT or MRI of the brain before the start of therapy available: No brain metastases; 4. No other malignancy in the preceding 2 years, except non-melanoma skin cancer or any carcinoma in situ; 5. No prior cranial irradiation; 6 Patient should be suitable for radical treatment with Platinum-based chemotherapy and is planned to receive radical loco-regional therapy: concurrent or sequential chemotherapy (Platinum-based) and radiotherapy with or without surgery (Radiotherapy dose without surgery at least a biological equivalent of 60 Gy (20)); 7. Patients must sign a study-specific informed consent at the time of registration. At the same time, thus before randomization, the baseline forms (CTCAE3.0, QLQ-C30 and EuroQol 5D) should be filled out. Randomization: 1. Patient has been registered in the study and has completed appropriate radical treatment, no more than 6 weeks before. Registration is thus allowed either before or after radical therapy; 2. The patient is ready to receive PCI within 1 week of randomization (if randomized to PCI arm); 3. There is no clinical evidence of progressive disease after chemo-radiation (no imaging is requested); 4. No evidence of extracranial distant metastatic disease; 5. Signed informed consent for randomization.
Exclusion criteria
Exclusion criteria: Registration: 1. Pregnant women are ineligible as treatment involves unforeseen risks to the participant and to the embryo or fetus; patients with childbearing potential must practice appropriate contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether PCI decreases the proportion of patients developing symptomatic brain metastases in patients with radically treated stage III NSCLC. 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the time to develop neurological symptoms (confirmed or unconfirmed by imaging); 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; 3. To determine the Quality of Life (QoL) (QLQ-C30 and EuroQol 5D); 4. To determine the effect of PCI on the overall survival; 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. | — |
Contacts
Public ContactD.J. Storm
NVALT Datacenter NKI-AVL Plesmanlaan 121
Outcome results
None listed