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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by AZ-VUB.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
AZ-VUB
ClinicalTrials.gov Identifier:
NCT00727350
First received: July 31, 2008
Last updated: August 1, 2008
Last verified: August 2008
  Purpose

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)


Condition Intervention Phase
Non Small Cell Lung Carcinoma
Radiation: Fractionated stereotactic body radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.

Resource links provided by NLM:


Further study details as provided by AZ-VUB:

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). [ 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. ] [ Designated as safety issue: Yes ]

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. [ 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: March 2007
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727350

Contacts
Contact: Samuel Bral, MD 00324763435 samuel.bral@uzbrussel.be

Locations
Belgium
UZ Brussel Recruiting
Jette, Brussels, Belgium, 1090
Contact: Samuel Bral, MD    003224763435    samuel.bral@uzbrussel.be   
Principal Investigator: Samuel Bral, MD         
Sponsors and Collaborators
AZ-VUB
  More Information

No publications provided by AZ-VUB

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samuel Bral, AZ-VUB
ClinicalTrials.gov Identifier: NCT00727350     History of Changes
Other Study ID Numbers: SBRT-NSCLC
Study First Received: July 31, 2008
Last Updated: August 1, 2008
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by AZ-VUB:
NSCLC
Novalis
Stereotactic
SBRT
T1, T2 or T3NO NSCLC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014