Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC)

NCT00870116 | Unknown DMC

• 2 other identifiers: SBRT CNPCET2008-067
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to evaluate local disease control after 2 years in patients with non-metastatic, non-operated non-small-cell lung cancer treated by radiotherapy. Eligible patients will be recruited and registered consecutively (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 4 years. The number of patients required in this multicentric prospective study is 120:

• 20 patients in the SBRT-1 arm (cyberknife),
• 80 patients in the SBRT-2 arm (linear accelerator-based)
• 20 patients in the conformational radiotherapy arm. This is a prospective, multicentric, non comparative and non randomized study.

Conditions

Non Small Cell Lung Cancer

Keywords

SBRT; non-operated; non-metastatic; non-small-cell lung cancer; conformational radiotherapy; non-operated non-metastatic non-small-cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy

  2 years

Secondary Outcomes (4)

• Health economic evaluation of the various methods used for stereotactic radiotherapy

  during treatment / post treatment

• Prospective evaluation of acute and late toxicities of SBRT

  M1, M3, M6, M12, M18 and M24

• Study of quality of life in the 3 groups

  inclusion, M1, M3, M12

• Evaluation of progression-free survival and overall survival in the 3 groups

  No time

Study Arms (3)

1 - SBRT using cyberknife

OTHER

SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks

Radiation: SBRT by cyberknife

2 - SBRT using linear accelerator

OTHER

SBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks

Radiation: SBRT by linear accelerator

3 - Conformational radiotherapy

OTHER

Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks

Radiation: Conformational radiotherapy

Interventions

SBRT by cyberknife RADIATION

treatment = 2x15 Gy during 2 weeks

1 - SBRT using cyberknife

SBRT by linear accelerator RADIATION

treatment = 2x15 Gy during 2 weeks

2 - SBRT using linear accelerator

Conformational radiotherapy RADIATION

treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)

3 - Conformational radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-operated non-small-cell lung cancer (NSCLC) (inoperable tumor or patient refusal of surgery)
• cytologically or histologically proven NSCLC Or
• primitive pulmonary tumor of unproven malignancy
• macroscopically normal bronchial endoscopy, negative cytology and biopsies
• AND size increase on 2 successive scans (at 10-12 weeks interval)
• AND hypermetabolic PET-CT pattern
• AND absence of other proven etiology
• Tumor \< 5cm, distant (\> 1.5 cm) from large vessels, principally in the bronchus and spinal-cord
• No metastasis: M0
• No lymph node involvement: N0
• Functional respiratory evaluation (FRE) compatible with thoracic irradiation
• Maximum expiratory flow-volume \> 30% theoretical value
• Age \>= 18
• ECOG PS \<= 2
• Female patients of childbearing potential: effective method of contraception

You may not qualify if:

• Previously operated tumors
• Previous thoracic irradiation
• Previous or concurrent primary malignancies at other sites (except basocellular skin cancer or cervical cancer in situ or complete remission for more than 5 years)
• Life expectancy \< 6 months
• Pregnant or lactating woman
• Difficult follow-up
• Patient deprived of freedom

Sponsors & Collaborators

• Centre Leon Berard: lead
• The Biostatistics and Therapy Evaluation Unit: collaborator
• National Cancer Institute, France: collaborator

Study Sites (9)

Centre Georges François Leclerc

Dijon, 21000, France

Location

Centre Oscar Lambret

Lille, 59000, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Centre Val d'Aurelle Paul Lamarque

Montpellier, 34000, France

Location

Centre Antoine Lacassagne

Nice, 06000, France

Location

Hôpital Tenon

Paris, 75012, France

Location

CHLS

Pierre-Bénite, 69495, France

Location

Centre René Gauducheau

Saint-Herblain, 44000, France

Location

Centre Alexis Vautrin

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (23)

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• Pommier P, Ndiaga Gueye N, Buron C, Meyroneinc S. Modélisation du coût de l'innovation thérapeutique pour l'aide à la décision. Application à la radiothérapie par ions carbone (projet ETOILE). Santé et systémique 2007 ; 10 : 217-31

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  PMID: 16115740 RESULT

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  PMID: 12683544 RESULT

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  PMID: 16169670 RESULT

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  PMID: 12738306 RESULT

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Line CLAUDE, MD

  Centre Léon Bérard, Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 6, 2013

Record last verified: 2013-02

Locations

FR (9)