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

Léon Bérard Center

Status: Unknown

Conditions: Non Small Cell Lung Cancer

Treatments: Radiation: SBRT by cyberknife; Radiation: Conformational radiotherapy; Radiation: SBRT by linear accelerator

Study type: Interventional

Funder types: Other

Identifiers

NCT00870116

ET2008-067

SBRT CNPC

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

1 - SBRT using cyberknife

Other group

Description:

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

Treatment:

Radiation: SBRT by cyberknife

2 - SBRT using linear accelerator

Other group

Description:

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

Treatment:

Radiation: SBRT by linear accelerator

3 - Conformational radiotherapy

Other group

Description:

Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks

Treatment:

Radiation: Conformational radiotherapy