NCT01138748

Brief Summary

Surgical resection with mediastinal lymph node sampling is currently the therapy of choice for early stage (I-II) non-small cell lung cancer (NSCLC). Selected patients unwilling or unable to tolerate surgery are referred for so-called 'curative' high dose radiotherapy. This has shown to result in a long term local disease control rate and a high cancer specific survival. The current trial addresses the issue if progression free survival (PFS) in patients treated with radiotherapy can be predicted by a multi-variate model derived from a composite of bio-imaging and biomarkers

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

June 4, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 4, 2013

Status Verified

February 1, 2013

Enrollment Period

1.9 years

First QC Date

June 4, 2010

Last Update Submit

February 1, 2013

Conditions

Inoperable Early Stage Non-small Cell Lung Cancer

Keywords

inoperable early stage non-small cell lung cancerradiation therapy

Outcome Measures

Primary Outcomes (1)

  • development and validation of a multi-variate predictive model

    To develop and validate a multi-variate predictive model based on bio-imaging and biomarkers for progression)free survival from 2 to 5 years.

    from 2 to 5 years

Secondary Outcomes (4)

  • the clinical response and complication rate

    from 2 to 5 years

  • local, regional or distant failure

    from 2 to 5 years

  • progression free survival

    from 2 to 5 years

  • disease specific overall survival

    from 2 to 5 years

Study Arms (1)

Radiation therapy

EXPERIMENTAL
Radiation: hypofractionated radiation therapy

Interventions

hypofractionated radiation therapyRADIATION

hypofractionated radiation therapy

Radiation therapy

Eligibility Criteria

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

You may qualify if:

  • Proof of cT1a/b - 2a/b N0M0 NSCLC
  • Informed Consent signed
  • Resectable tumour
  • \> 18 years old
  • men and women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Links

Study Officials

  • Jan Van Meerbeeck, MD,PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2010

First Posted

June 7, 2010

Study Start

November 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 4, 2013

Record last verified: 2013-02

Locations

BE(1)