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Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.

Primary Purpose

Non Small Cell Lung Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Fractionated stereotactic body radiation therapy
Sponsored by
AZ-VUB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Carcinoma focused on measuring NSCLC, Novalis, Stereotactic, SBRT, T1, T2 or T3NO NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Diagnosis of small cell lung cancer
  2. Lymph node involvement
  3. Prior radiotherapy or chemotherapy for lung cancer
  4. Pregnant or lactating women
  5. Known allergy for CT contrast
  6. No FDG-PET
  7. Mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study.
  8. 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.

Sites / Locations

  • UZ BrusselRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
July 31, 2008
Last Updated
August 1, 2008
Sponsor
AZ-VUB
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1. Study Identification

Unique Protocol Identification Number
NCT00727350
Brief Title
Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.
Official Title
Phase II Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
AZ-VUB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Carcinoma
Keywords
NSCLC, Novalis, Stereotactic, SBRT, T1, T2 or T3NO NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Fractionated stereotactic body radiation therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Time Frame
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 Outcome Measure Information:
Title
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.
Time Frame
Every 3 months for the first 2 years. From 3 to 5 years every 6 months. After 5 years follow-up will happen yearly.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel Bral, MD
Phone
00324763435
Email
samuel.bral@uzbrussel.be
Facility Information:
Facility Name
UZ Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel Bral, MD
Phone
003224763435
Email
samuel.bral@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Samuel Bral, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
20708849
Citation
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.
Results Reference
derived

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Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.

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