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

Information source: AZ-VUB
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Small Cell Lung Carcinoma

Intervention: Fractionated stereotactic body radiation therapy (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: AZ-VUB

Overall contact:
Samuel Bral, MD, Phone: 00324763435, Email: samuel.bral@uzbrussel.be

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)

Clinical Details

Official title: Phase II Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Samuel Bral, MD, Phone: 00324763435, Email: samuel.bral@uzbrussel.be

UZ Brussel, Jette, Brussels 1090, Belgium; Recruiting
Samuel Bral, MD, Phone: 003224763435, Email: samuel.bral@uzbrussel.be
Samuel Bral, MD, Principal Investigator
Additional Information

Starting date: March 2007
Last updated: August 1, 2008

Page last updated: August 23, 2015

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