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

Phase 3

Completed

• Conditions: Radical Treatment; Stage III Non-Small Cell Lung Cancer; Non Small Cell Lung Cancer (NSCLC)
• Interventions: Radiation: Prophylactic Cranial Irradiation

• Registration Number: NCT01282437
• Lead Sponsor: Maastricht Radiation Oncology

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-24
• Study First Posted: 2011-01-25
• Primary Completion: 2014-09
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prophylactic Cranial Irradiation	Prophylactic Cranial Irradiation	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients developing symptomatic brain metastasis	24 months after randomisation

Secondary Outcome Measures

Name	Time	Method
Quality of Life	24 months after randomisation	Measured by QLQ-C30 and EuroQol 5D
Time to develop neurological symptoms (confirmed or unconfirmed by imaging)	24 months after randomisation
Measurement of side effects (CTCAE3.0)	24 months after randomisation

Trial Locations

Locations (9)

RT Insitute Stedendriehoek; 🇳🇱 Deventer, Netherlands

UMCG Groningen; 🇳🇱 Groningen, Netherlands

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

VU Medical Center; 🇳🇱 Amsterdam, Netherlands

Dr. Bernard Verbeeten Institute; 🇳🇱 Tilburg, Netherlands

The Netherlands Cancer Institute; 🇳🇱 Amsterdam, Netherlands

Maastro Clinic; 🇳🇱 Maastricht, Limburg, Netherlands

Isala Klinieken; 🇳🇱 Zwolle, Netherlands

UMC Utrecht; 🇳🇱 Utrecht, Netherlands