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

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

Study Overview

• Status: Completed
• Conditions: NSCLC

• Study Type: Observational
• Enrollment (Anticipated): 170

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • VU University Medical Center
  • Amsterdam, Netherlands
    • Academic Medical Center
  • Amsterdam, Netherlands
    • NKI
  • Groningen, Netherlands
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive sequelae	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.	36 months

Collaborators and Investigators

• Sponsor: Maastricht Radiation Oncology
• Collaborators: University Medical Center Groningen; Maastricht University Medical Center; Amsterdam UMC, location VUmc; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); The Netherlands Cancer Institute
• Investigators: Principal Investigator: Dirk deruysscher, Maastro Clinic, The Netherlands

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: February 1, 2011
• First Submitted That Met QC Criteria: February 4, 2011
• First Posted (Estimate): February 7, 2011

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: lung cancer; Prophylactic Cranial Irradiation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 093074