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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Carcinoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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).

Outcome 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.

Safety Issue:

Yes

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

SBRT-NSCLC

NCT ID:

NCT00727350

Start Date:

March 2007

Completion Date:

December 2012

Related Keywords:

  • Non Small Cell Lung Carcinoma
  • NSCLC
  • Novalis
  • Stereotactic
  • SBRT
  • T1, T2 or T3NO NSCLC
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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