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

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01290809
• Other study ID #: 093074
• Status: Completed
• Phase: N/A
• First received: February 1, 2011
• Last updated: October 13, 2015
• Start date: January 2011
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam
Netherlands	NKI	Amsterdam
Netherlands	VU University Medical Center	Amsterdam
Netherlands	University Medical Center Groningen	Groningen

Sponsors (6)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Maastricht University Medical Center, The Netherlands Cancer Institute, University Medical Center Groningen, VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No