NCT00870116

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	SBRT by cyberknife	treatment = 2x15 Gy during 2 weeks
RADIATION	SBRT by linear accelerator	treatment = 2x15 Gy during 2 weeks
RADIATION	Conformational radiotherapy	treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)

Timeline

• Start date: 2009-04-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-03-26
• Last updated: 2013-03-06

Locations

9 sites across 1 country: France