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

Non Small Cell Lung Cancer (NSCLC) Clinical Trial

— NVALT11  

Official title:

Prophylactic Cranial Irradiation (PCI) Versus Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer; A Phase III Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282437
• Other study ID #: NVALT11
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2011
• Last updated: April 9, 2015
• Start date: January 2009
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: March 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer (NSCLC)
• Radical Treatment
• Stage III Non-Small Cell Lung Cancer

Intervention

Radiation:
• Prophylactic Cranial Irradiation
18 fractions of 2Gy 12 fractions of 2.5Gy 10 fractions of 3 Gy

Locations

Country	Name	City	State
Netherlands	The Netherlands Cancer Institute	Amsterdam
Netherlands	VU Medical Center	Amsterdam
Netherlands	RT Insitute Stedendriehoek	Deventer
Netherlands	UMCG Groningen	Groningen
Netherlands	Maastro Clinic	Maastricht	Limburg
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	Dr. Bernard Verbeeten Institute	Tilburg
Netherlands	UMC Utrecht	Utrecht
Netherlands	Isala Klinieken	Zwolle

Sponsors (3)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	The Netherlands Cancer Institute, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients developing symptomatic brain metastasis		24 months after randomisation	No
Secondary	Time to develop neurological symptoms (confirmed or unconfirmed by imaging)		24 months after randomisation	No
Secondary	Measurement of side effects (CTCAE3.0)		24 months after randomisation	Yes
Secondary	Quality of Life	Measured by QLQ-C30 and EuroQol 5D	24 months after randomisation	No