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

Sponsor

Centre Leon Berard (Other)

Overall Status

Unknown status

CT.gov ID

NCT00870116

Collaborator

The Biostatistics and Therapy Evaluation Unit (Other), National Cancer Institute, France (Other)

120

Enrollment

Locations

Arms

Duration (Months)

13.3

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Radiation: SBRT by cyberknife Radiation: SBRT by linear accelerator Radiation: Conformational radiotherapy	N/A

Detailed Description

The main objective of this study is to do a health economic evaluation of innovating techniques in radiotherapy.

SBRT is the very precise delivery of high-powered radiation to small target volumes, using multiple low-intensity beams. Extremely precise patient positioning and target location is essential for accurate treatment delivery.

Several studies have shown a benefit of SBRT in terms of local control and progression-free survival, in particular for the treatment of cerebral metastases of limited number and size.

The development of this technique is recent. The number of treatment sessions is low: 1 to 4.

But the patient is exposed to a major risk of toxicity in several organs: the bronchi, the lungs, large vessels, the oesophagus and the spinal-cord.

Pulmonary SBRT imposes strict rules and the use of specific equipment.

Extra-cranial SBRT can be realized using either:

Conventional linear-accelerator equipped SBRT,
Cyberknife SBRT.

3 groups of treatment will be evaluated in this study:

SBRT by cyberknife,
SBRT by linear accelerator,
Conformational radiotherapy (free breathing or breath holding).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0

Study Start Date :

Apr 1, 2009

Anticipated Primary Completion Date :

Mar 1, 2013

Anticipated Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 - SBRT using cyberknife SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks	Radiation: SBRT by cyberknife treatment = 2x15 Gy during 2 weeks
Other: 2 - SBRT using linear accelerator SBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks	Radiation: SBRT by linear accelerator treatment = 2x15 Gy during 2 weeks
Other: 3 - Conformational radiotherapy Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks	Radiation: Conformational radiotherapy treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)

Arm

Intervention/Treatment

Other: 1 - SBRT using cyberknife

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

Radiation: SBRT by cyberknife

treatment = 2x15 Gy during 2 weeks

Other: 2 - SBRT using linear accelerator

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

Radiation: SBRT by linear accelerator

treatment = 2x15 Gy during 2 weeks

Other: 3 - Conformational radiotherapy

Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks

Radiation: Conformational radiotherapy

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

Outcome Measures

Primary Outcome Measures

Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy [2 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
Written advice of the RCP (conciliation meeting) present in the patient file
Mandatory affiliation with a social security system
Written, signed informed consent

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Centre Georges François Leclerc	Dijon	France	21000
2	Centre Oscar Lambret	Lille	France	59000
3	Centre Leon Berard	Lyon	France	69008
4	Centre Val d'Aurelle Paul Lamarque	Montpellier	France	34000
5	Centre Antoine Lacassagne	Nice	France	06000
6	Hôpital Tenon	Paris	France	75012
7	CHLS	Pierre Bénite	France	69495
8	Centre René Gauducheau	Saint Herblain	France	44000
9	Centre Alexis Vautrin	Vandoeuvre les Nancy	France	54511