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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01282437
Recruitment Status : Completed
First Posted : January 25, 2011
Last Update Posted : April 10, 2015
University Medical Center Groningen
The Netherlands Cancer Institute
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer (NSCLC) Radical Treatment Stage III Non-Small Cell Lung Cancer Radiation: Prophylactic Cranial Irradiation Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : January 2009
Actual Primary Completion Date : September 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Prophylactic Cranial Irradiation Radiation: Prophylactic Cranial Irradiation
  • 18 fractions of 2Gy
  • 12 fractions of 2.5Gy
  • 10 fractions of 3 Gy
No Intervention: Observation
Patients will not receive PCI, but will be observed and the same items will be measured as in the PCI-arm.

Primary Outcome Measures :
  1. Proportion of patients developing symptomatic brain metastasis [ Time Frame: 24 months after randomisation ]

Secondary Outcome Measures :
  1. Time to develop neurological symptoms (confirmed or unconfirmed by imaging) [ Time Frame: 24 months after randomisation ]
  2. Measurement of side effects (CTCAE3.0) [ Time Frame: 24 months after randomisation ]
  3. Quality of Life [ Time Frame: 24 months after randomisation ]
    Measured by QLQ-C30 and EuroQol 5D

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01282437

Maastro Clinic
Maastricht, Limburg, Netherlands, 6229 ET
The Netherlands Cancer Institute
Amsterdam, Netherlands
VU Medical Center
Amsterdam, Netherlands
RT Insitute Stedendriehoek
Deventer, Netherlands
UMCG Groningen
Groningen, Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Dr. Bernard Verbeeten Institute
Tilburg, Netherlands
UMC Utrecht
Utrecht, Netherlands
Isala Klinieken
Zwolle, Netherlands
Sponsors and Collaborators
Maastricht Radiation Oncology
University Medical Center Groningen
The Netherlands Cancer Institute
Principal Investigator: Dirk De Ruysscher, MD, PhD NVALT oncology foundation
Principal Investigator: Harry Groen, MD, PhD University Medical Center Groningen

Responsible Party: Maastricht Radiation Oncology Identifier: NCT01282437     History of Changes
Other Study ID Numbers: NVALT11
First Posted: January 25, 2011    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms