Prophylactic Cranial Irradiation (PCI) versus observation in radically treated patients with stage III non-small cell lung cancer: A phase III randomized study (NVALT-11/ DLCRG-02).

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 450

Inclusion Criteria

4.1 Eligibility for 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.
8. 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
4.2 Conditions for Patient eligibility at 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

n.a.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Patients will be followed for development of symptomatic brain metastases.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary endpoints are: side effects, survival, quality of life (QLQ-C30 and<br /><br>EuroQol 5D), quality adjusted survival (QALYs) and health care costs.</p><br>