NCT00727350

Brief Summary

The study population will exist of patients with a histological diagnosis of NSCLC, stage T1, T2 or T3NO who are not fit for or who refuse surgery. A prospective data analysis will be performed on tumor response, potential acute and late toxicity and survival. A radiotherapy dose of 4x15Gy or 3x 20Gy will be given over 2 weeks with dynamic 3D-conformal arc therapy (Novalis TM)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 31, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

August 4, 2008

Status Verified

August 1, 2008

Enrollment Period

5 years

First QC Date

July 31, 2008

Last Update Submit

August 1, 2008

Conditions

Non Small Cell Lung Carcinoma

Keywords

NSCLCNovalisStereotacticSBRTT1, T2 or T3NO NSCLC

Outcome Measures

Primary Outcomes (1)

  • To monitor potential acute and late toxicity in patients with stage T1,T2,T3N0 non small cell lung carcinoma (NSCLC), treated with primary stereotactic body radiation therapy (SBRT).

    Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly.

Secondary Outcomes (1)

  • Local control at 2 years. Overall survival, local progression free survival, disease free survival, time to progression and local,regional or disseminated recurrence.Quality of life. Internal and Intra-fractional tumor motion. Biopsy samples.

    Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly.

Study Arms (1)

1

EXPERIMENTAL

For centrally located T1 and T2 lesions 4 x 15 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 20 Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week.

Radiation: Fractionated stereotactic body radiation therapy

Interventions

Fractionated stereotactic body radiation therapyRADIATION

For centrally located T1 and T2 lesions 4 x 15 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 20 Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week.

1

Eligibility Criteria

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

You may qualify if:

  • Stage T1,T2,T3N0M0 NSCLC, histological confirmation either by biopsy or cytology
  • Maximal tumor diameter of 6 cm
  • Only T3 lesions based upon thoracic wall involvement
  • Informed consent is required
  • Life expectancy of at least 6 months
  • Age \> 18 y.
  • Karnofsky score ≥ 70 or ECOG score ≤ 1
  • Inoperable patients or patients refusing surgery
  • Patients with measurable lesion (according to RECIST criteria)

You may not qualify if:

  • Diagnosis of small cell lung cancer
  • Lymph node involvement
  • Prior radiotherapy or chemotherapy for lung cancer
  • Pregnant or lactating women
  • Known allergy for CT contrast
  • No FDG-PET
  • Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  • Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to return for follow-up visits, extreme degradation of lung function tests and patients not likely to complete the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

Related Publications (1)

  • Bral S, Gevaert T, Linthout N, Versmessen H, Collen C, Engels B, Verdries D, Everaert H, Christian N, De Ridder M, Storme G. Prospective, risk-adapted strategy of stereotactic body radiotherapy for early-stage non-small-cell lung cancer: results of a Phase II trial. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1343-9. doi: 10.1016/j.ijrobp.2010.04.056. Epub 2010 Aug 12.

    PMID: 20708849DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Samuel Bral, MD

CONTACT

00324763435samuel.bral@uzbrussel.be

Study Design

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

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 4, 2008

Study Start

March 1, 2007

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

August 4, 2008

Record last verified: 2008-08

Locations

BE(1)