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Prophylactic Cranial Irradiation (PCI) Cognitive Tests in Non-small Cell Lung Cancer (NSCLC) Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Maastricht Radiation Oncology
Sponsor:
Collaborators:
The Netherlands Cancer Institute
VU University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Maastricht University Medical Center
University Medical Centre Groningen
Information provided by (Responsible Party):
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01290809
First received: February 1, 2011
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

Stage III non-small cell lung cancer (NSCLC) patients constitute a significant proportion of the lung cancer population. The prognosis of these patients has improved over the years due the introduction of combined modality treatment, including high-dose chemo-radiotherapy. The brain, however, remains one of the major sites of failure. Patients with brain metastasis suffer from a variety of neurological, cognitive and emotional difficulties that are known to adversely affect the health-related quality of life. Prophylactic Cranial Irradiation (PCI) can prevent or delay the development of brain metastasis, and as such can improve neurological disease-free survival and consequently health-related quality of life. But survival is short, and toxicities are real, as PCI in itself can also induce adverse effects. The cognitive adverse effects of PCI are not sufficiently illuminated and documented, due to the lack of formal and systematic evaluation in patient populations expected to have short survival. Also, recent attempts to reduce cognitive side effects of PCI by the application of hippocampal-avoidance PCI in order to prevent memory deficits have not been fully evaluated yet.

Before PCI can be offered routinely to stage III NSCLC patients in daily practice, the costs and benefits of this therapy should be investigated properly, to allow for well-informed treatment choices.


Condition
NSCLC

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Cognitive Sequelae of Prophylactic Cranial Irradiation in Non-small Cell Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • cognitive sequelae [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    The proposed study will investigate the cognitive sequelae of PCI in NSCLC patients in the context of a phase III randomized trial (Nederlandse vereniging van artsen voor longziekten en tuberculose: NVALT-11) on the efficacy of PCI in decreasing the proportion of NSCLC patients developing brain metastasis, and the impact of PCI on neurological symptoms and health-related quality of life.


Estimated Enrollment: 170
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Prophylactic Cranial Irradiation
NSCLC patients treated with whole brain PCI: cognitive functioning as assessed by neuropsychological tests?
no Prophylactic Cranial Irradiation
NSCLC patients not treated with whole brain PCI: cognitive functioning as assessed by neuropsychological tests?

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients will be recruited from 5 hospitals participating in the phase III trial: Prophylactic Cranial Irradiation (PCI) versus observation in radically treated patients with stage III non-small lung cancer: a phase III randomized study ((NVALT 11/DLCRG-02).

Criteria

Inclusion Criteria:

  • UICC stage III A or III B (without malignant pleural or pericardial effusion) non-small cell lung cancer
  • Whole body PDG-PET scan before the start of therapy available: no distant metastasis.
  • CT or preferably MRI of the brain before the start of radical therapy available; no brain metastasis.
  • Platinum-based chemotherapy is mandatory.
  • Radical local therapy: concurrent or sequential chemotherapy and radiotherapy with or without surgery.
  • Radiotherapy dose without surgery to at least biological equivalent of 60 Gy.
  • No prior cranial irradiation.sufficient proficiency in Dutch language
  • sufficient proficiency in Dutch language
  • MRI (and not CT scan) pre-PCI

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290809

Contacts
Contact: Dirk De Ruysscher +31 884455666 dirk.deruysscher@maastro.nl
Contact: Brigitta Baumert +31 884455666 brigitta.baumert@maastro.nl

Locations
Netherlands
Academic Medical Center Recruiting
Amsterdam, Netherlands
Contact: L Stalpers         
Contact: A Uitterhoeve         
NKI Recruiting
Amsterdam, Netherlands
Contact: Jose Belderbos       j.belderbos@nki.nl   
Contact: Sanne Schagen       s.schagen@nki.nl   
Principal Investigator: J Belderbos         
VU University Medical Center Recruiting
Amsterdam, Netherlands
Contact: F Lagerwaard         
Contact: M Klein         
University Medical Center Groningen Recruiting
Groningen, Netherlands
Contact: E Wiegman         
Sponsors and Collaborators
Maastricht Radiation Oncology
The Netherlands Cancer Institute
VU University Medical Center
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Maastricht University Medical Center
University Medical Centre Groningen
Investigators
Principal Investigator: Dirk deruysscher Maastro Clinic, The Netherlands
  More Information

No publications provided

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01290809     History of Changes
Other Study ID Numbers: 093074
Study First Received: February 1, 2011
Last Updated: September 16, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht Radiation Oncology:
Prophylactic Cranial Irradiation
lung cancer

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

ClinicalTrials.gov processed this record on November 20, 2014