NCT01138722

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 relationship between blood and tissue biomarkers, bio-imaging and pathology in patients with early stage NSCLC treated with hypofractionated radiation therapy and surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

May 1, 2010

Completed
1 month until next milestone

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
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

July 8, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

June 4, 2010

Last Update Submit

July 7, 2021

Conditions

Early Stage Non-small Cell Lung Cancer

Keywords

early stage non-small cell lung cancerhypofractionated radiation therapy

Outcome Measures

Primary Outcomes (1)

  • pathological effects of hypofractionated radiation therapy

    To describe the pathological effects of hypofractionated radioation therapy (RT) and to address the relationship with blood and tissue biomarkers and bio-imaging.

    at 2 years

Secondary Outcomes (7)

  • clinical response rate

    from 2 to 5 years

  • the accuracy of clinical mediastinal staging

    from 2 to 5 years

  • the 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

  • +2 more secondary outcomes

Interventions

hypofractionated radiation therapy followed by surgeryRADIATION

hypofractionated radiation therapy followed by surgery

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
  • Operable patient
  • \> 18 years old
  • men and women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Antwerp

Antwerp, Belgium

Location

University Hospital Ghent

Ghent, Belgium

Location

Related Links

Study Officials

  • Jan Van Meerbeeck, MD, PhD

    University Hospital Ghent, Belgium

    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

May 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

July 8, 2021

Record last verified: 2021-07

Locations

BE(2)