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

NCT ID: NCT00727350

Last Updated: 2008-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2012-12-31

Brief Summary

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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)

Detailed Description

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Conditions

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Non Small Cell Lung Carcinoma

Keywords

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NSCLC Novalis Stereotactic SBRT T1, T2 or T3NO NSCLC

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fractionated stereotactic body radiation therapy

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AZ-VUB

OTHER

Sponsor Role lead

Responsible Party

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AZ-VUB

Locations

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UZ Brussel

Jette, Brussels Capital, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Samuel Bral, MD

Role: CONTACT

Phone: 00324763435

Email: [email protected]

Facility Contacts

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Samuel Bral, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 20708849 (View on PubMed)

Other Identifiers

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SBRT-NSCLC

Identifier Type: -

Identifier Source: org_study_id