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

This study is currently recruiting participants.
Verified January 2013 by Maastricht Radiation Oncology
Sponsor:
Collaborators:
University Medical Centre Groningen
The Netherlands Cancer Institute
Information provided by:
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01282437
First received: January 24, 2011
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • Proportion of patients developing symptomatic brain metastasis [ Time Frame: 24 months after randomisation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to develop neurological symptoms (confirmed or unconfirmed by imaging) [ Time Frame: 24 months after randomisation ] [ Designated as safety issue: No ]
  • Measurement of side effects (CTCAE3.0) [ Time Frame: 24 months after randomisation ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 24 months after randomisation ] [ Designated as safety issue: No ]
    Measured by QLQ-C30 and EuroQol 5D


Estimated Enrollment: 315
Study Start Date: January 2009
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282437

Contacts
Contact: Dirk De Ruysscher, MD, PhD +31 88 44 55 700 dirk.deruysscher@maastro.nl
Contact: Chantal Overhof +31 88 44 55 686 chantal.overhof@maastro.nl

Locations
Netherlands
Maastro Clinic Recruiting
Maastricht, Limburg, Netherlands, 6229 ET
Contact: Dirk De Ruysscher, MD, PhD     +31 88 44 55 700     dirk.deruysscher@maastro.nl    
The Netherlands Cancer Institute Recruiting
Amsterdam, Netherlands
VU Medical Center Recruiting
Amsterdam, Netherlands
RT Insitute Stedendriehoek Recruiting
Deventer, Netherlands
UMCG Groningen Recruiting
Groningen, Netherlands
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands
Dr. Bernard Verbeeten Institute Recruiting
Tilburg, Netherlands
UMC Utrecht Recruiting
Utrecht, Netherlands
Isala Klinieken Recruiting
Zwolle, Netherlands
Sponsors and Collaborators
Maastricht Radiation Oncology
University Medical Centre Groningen
The Netherlands Cancer Institute
Investigators
Principal Investigator: Dirk De Ruysscher, MD, PhD NVALT oncology foundation
Principal Investigator: Harry Groen, MD, PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: Prof. Dr. D.K.M. De Ruysscher, Maastro Clinic
ClinicalTrials.gov Identifier: NCT01282437     History of Changes
Other Study ID Numbers: NVALT11
Study First Received: January 24, 2011
Last Updated: January 24, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on June 17, 2013