NCT01282437

Brief Summary

For patients with stage III non-small cell lung cancer, which is radically treated, we will investigate whether prophylactic cranial irradiation (PCI) should become standard of care to prevent brain metastases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
315

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_3

Geographic Reach
1 country

9 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, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

5.7 years

First QC Date

January 24, 2011

Last Update Submit

April 9, 2015

Conditions

Non Small Cell Lung Cancer (NSCLC)Radical TreatmentStage III Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients developing symptomatic brain metastasis

    24 months after randomisation

Secondary Outcomes (3)

  • Time to develop neurological symptoms (confirmed or unconfirmed by imaging)

    24 months after randomisation

  • Measurement of side effects (CTCAE3.0)

    24 months after randomisation

  • Quality of Life

    24 months after randomisation

Study Arms (2)

Prophylactic Cranial Irradiation

EXPERIMENTAL
Radiation: Prophylactic Cranial Irradiation

Observation

NO INTERVENTION

Patients will not receive PCI, but will be observed and the same items will be measured as in the PCI-arm.

Interventions

Prophylactic Cranial IrradiationRADIATION

* 18 fractions of 2Gy * 12 fractions of 2.5Gy * 10 fractions of 3 Gy

Prophylactic Cranial Irradiation

Eligibility Criteria

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

You may qualify if:

  • UICC stage IIIA or IIIB (without malignant pleural of pericardial effusion) non-small cell lung cancer (histology or cytology)
  • Whole body FDG-PET-scan before start of therapy available: No distant metastases
  • CT or MRI of the brain before the start of radical therapy available: No brain metastases
  • Platinum-based chemotherapy is mandatory
  • Radical local therapy: concurrent of sequential chemotherapy (platinum-based) and radiotherapy with or without surgery
  • Radiotherapy dose without surgery at least a biological equivalent of 60Gy
  • No prior cranial irradiation
  • Patients must sign a study-specific informed consent at the time of registration

You may not qualify if:

  • The opposite of the above

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

VU Medical Center

Amsterdam, Amsterdam, Netherlands

Location

Maastro Clinic

Maastricht, Limburg, 6229 ET, Netherlands

Location

UMCG Groningen

Groningen, Provincie Groningen, Netherlands

Location

UMC Utrecht

Utrecht, Utrecht, Netherlands

Location

The Netherlands Cancer Institute

Amsterdam, Netherlands

Location

RT Insitute Stedendriehoek

Deventer, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Dr. Bernard Verbeeten Institute

Tilburg, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

Related Publications (1)

  • Witlox WJA, Ramaekers BLT, Joore MA, Dingemans AC, Praag J, Belderbos J, Tissing-Tan C, Herder G, Haitjema T, Ubbels JF, Lagerwaard J, El Sharouni SY, Stigt JA, Smit EF, van Tinteren H, van der Noort V, Groen HJM, De Ruysscher DKM. Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients: Results from the NVALT-11/DLCRG-02 phase III study. Radiother Oncol. 2020 Mar;144:65-71. doi: 10.1016/j.radonc.2019.10.016. Epub 2019 Nov 14.

    PMID: 31733490DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Dirk De Ruysscher, MD, PhD

    NVALT oncology foundation

    PRINCIPAL INVESTIGATOR

  • Harry Groen, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2011

First Posted

January 25, 2011

Study Start

January 1, 2009

Primary Completion

September 1, 2014

Study Completion

March 1, 2015

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

NL(9)