NCT01290809

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

4.2 years

First QC Date

February 1, 2011

Last Update Submit

October 13, 2015

Conditions

NSCLC

Keywords

Prophylactic Cranial Irradiationlung cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Academic Medical Center

Amsterdam, Netherlands

Location

NKI

Amsterdam, Netherlands

Location

VU University Medical Center

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, Netherlands

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Dirk deruysscher

    Maastro Clinic, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 7, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2015

Study Completion

October 1, 2015

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

NL(4)