Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC (NVALT11)

Maastricht Radiation Oncology

Status and phase: Completed; Phase 3

Conditions: Stage III Non-Small Cell Lung Cancer; Radical Treatment; Non Small Cell Lung Cancer (NSCLC)

Treatments: Radiation: Prophylactic Cranial Irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT01282437

NVALT11

Details and patient eligibility

About

For patients with stage III non-small cell lung cancer, which is radically treated, we will investigate whether prophylactic cranial irradiation (PCI) should become standard of care to prevent brain metastases.

Full description

For this group of patients, brain metastases are one of the major sites of tumor failure. Radical therapy of symptomatic brain metastases is seldom possible and only very rarely, long term survival can be achieved. PCI has shown to reduce the incidence of brain metastases in patients with non-small cell lung cancer to the same extent as in limited disease small-cell lung cancer. However, the exact value of PCI in stage III NSCLC patient, treated with contemporary chemo-radiation schedule with or without surgery, remains unsettled. Therefore this study is launched, in order to investigate whether PCI should become the standard of care in patients with stage III NSCLC who are treated with curative intention.

Enrollment: 315 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• UICC stage IIIA or IIIB (without malignant pleural of pericardial effusion) non-small cell lung cancer (histology or cytology)
• Whole body FDG-PET-scan before start of therapy available: No distant metastases
• CT or MRI of the brain before the start of radical therapy available: No brain metastases
• Platinum-based chemotherapy is mandatory
• Radical local therapy: concurrent of sequential chemotherapy (platinum-based) and radiotherapy with or without surgery
• Radiotherapy dose without surgery at least a biological equivalent of 60Gy
• No prior cranial irradiation
• Patients must sign a study-specific informed consent at the time of registration

Exclusion criteria

• The opposite of the above

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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315 participants in 2 patient groups

Prophylactic Cranial Irradiation

Experimental group

Treatment:

Radiation: Prophylactic Cranial Irradiation

Observation

No Intervention group

Description:

Patients will not receive PCI, but will be observed and the same items will be measured as in the PCI-arm.