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OpenTrials
Completed

NCT Number: NCT01290809

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Academic Medical Center, Amsterdam, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. cognitive sequelae

    Time frame: 36 months

    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.

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Amsterdam UMC, location VUmc
  • Maastricht University Medical Center
  • The Netherlands Cancer Institute
  • University Medical Center Groningen

Registry information

Official study title

Cognitive Sequelae of Prophylactic Cranial Irradiation in Non-small Cell Lung Cancer Patients

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Feb 7, 2011
Registry last updated
Oct 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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