- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00870116
Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC) (SBRT-NSCLC)
SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Dijon, France, 21000
- Centre Georges François Leclerc
-
Lille, France, 59000
- Centre Oscar Lambret
-
Lyon, France, 69008
- Centre Léon Berard
-
Montpellier, France, 34000
- Centre Val d'Aurelle Paul Lamarque
-
Nice, France, 06000
- Centre Antoine LACASSAGNE
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Paris, France, 75012
- Hôpital Tenon
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Pierre Bénite, France, 69495
- CHLS
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Saint Herblain, France, 44000
- Centre Rene Gauducheau
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Vandoeuvre les Nancy, France, 54511
- Centre Alexis Vautrin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1 - SBRT using cyberknife
SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks
|
treatment = 2x15 Gy during 2 weeks
|
Other: 2 - SBRT using linear accelerator
SBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks
|
treatment = 2x15 Gy during 2 weeks
|
Other: 3 - Conformational radiotherapy
Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks
|
treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Health economic evaluation of the various methods used for stereotactic radiotherapy
Time Frame: during treatment / post treatment
|
during treatment / post treatment
|
Prospective evaluation of acute and late toxicities of SBRT
Time Frame: M1, M3, M6, M12, M18 and M24
|
M1, M3, M6, M12, M18 and M24
|
Study of quality of life in the 3 groups
Time Frame: inclusion, M1, M3, M12
|
inclusion, M1, M3, M12
|
Evaluation of progression-free survival and overall survival in the 3 groups
Time Frame: No time
|
No time
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Line CLAUDE, MD, Centre Léon Bérard, Lyon
Publications and helpful links
General Publications
- Noel G, Bollet MA, Noel S, Feuvret L, Boisserie G, Tep B, Delattre JY, Baillet F, Ambroise Valery C, Cornu P, Mazeron JJ. Linac stereotactic radiosurgery: an effective and safe treatment for elderly patients with brain metastases. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1555-61. doi: 10.1016/j.ijrobp.2005.04.037. Epub 2005 Jul 18.
- Kaplan EL., MP. Nonparametric estimation from incomplete observations. 1958. J Am Stat Assoc 1958; 53:457-481
- Pommier P. Modélisation spatiale et médico-économique des thérapeutiques innovantes : à propos du projet français ETOILE d'hadronthérapie par ions carbone. Thèse de Science en économie de la santé ; juin 2005
- 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
- Evaluation de la radiothérapie fractionnée en condition stéréotaxiques des métastases cérébrales, STIC 2005
- Tschung Sibley G. Radiotherapy for patient with medically inoperable stage I non-small cell lung cancer smaller doses and higher doses - a review. Cancer 2003;41:1-11
- Timmerman R, Papiez L, McGarry R, Likes L, DesRosiers C, Frost S, Williams M. Extracranial stereotactic radioablation: results of a phase I study in medically inoperable stage I non-small cell lung cancer. Chest. 2003 Nov;124(5):1946-55. doi: 10.1378/chest.124.5.1946.
- McGarry RC, Papiez L, Williams M, Whitford T, Timmerman RD. Stereotactic body radiation therapy of early-stage non-small-cell lung carcinoma: phase I study. Int J Radiat Oncol Biol Phys. 2005 Nov 15;63(4):1010-5. doi: 10.1016/j.ijrobp.2005.03.073. Epub 2005 Aug 22.
- Whyte RI, Crownover R, Murphy MJ, Martin DP, Rice TW, DeCamp MM Jr, Rodebaugh R, Weinhous MS, Le QT. Stereotactic radiosurgery for lung tumors: preliminary report of a phase I trial. Ann Thorac Surg. 2003 Apr;75(4):1097-101. doi: 10.1016/s0003-4975(02)04681-7.
- Xia T, Li H, Sun Q, Wang Y, Fan N, Yu Y, Li P, Chang JY. Promising clinical outcome of stereotactic body radiation therapy for patients with inoperable Stage I/II non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Sep 1;66(1):117-25. doi: 10.1016/j.ijrobp.2006.04.013. Epub 2006 Jun 9.
- Nagata Y, Takayama K, Matsuo Y, Norihisa Y, Mizowaki T, Sakamoto T, Sakamoto M, Mitsumori M, Shibuya K, Araki N, Yano S, Hiraoka M. Clinical outcomes of a phase I/II study of 48 Gy of stereotactic body radiotherapy in 4 fractions for primary lung cancer using a stereotactic body frame. Int J Radiat Oncol Biol Phys. 2005 Dec 1;63(5):1427-31. doi: 10.1016/j.ijrobp.2005.05.034. Epub 2005 Sep 19.
- Onishi H, Araki T, Shirato H, Nagata Y, Hiraoka M, Gomi K, Yamashita T, Niibe Y, Karasawa K, Hayakawa K, Takai Y, Kimura T, Hirokawa Y, Takeda A, Ouchi A, Hareyama M, Kokubo M, Hara R, Itami J, Yamada K. Stereotactic hypofractionated high-dose irradiation for stage I nonsmall cell lung carcinoma: clinical outcomes in 245 subjects in a Japanese multiinstitutional study. Cancer. 2004 Oct 1;101(7):1623-31. doi: 10.1002/cncr.20539.
- Hof H, Herfarth KK, Munter M, Hoess A, Motsch J, Wannenmacher M, Debus J J. Stereotactic single-dose radiotherapy of stage I non-small-cell lung cancer (NSCLC). Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):335-41. doi: 10.1016/s0360-3016(02)04504-2.
- Uematsu M, Shioda A, Suda A, Fukui T, Ozeki Y, Hama Y, Wong JR, Kusano S. Computed tomography-guided frameless stereotactic radiotherapy for stage I non-small cell lung cancer: a 5-year experience. Int J Radiat Oncol Biol Phys. 2001 Nov 1;51(3):666-70. doi: 10.1016/s0360-3016(01)01703-5.
- Fukumoto S, Shirato H, Shimzu S, Ogura S, Onimaru R, Kitamura K, Yamazaki K, Miyasaka K, Nishimura M, Dosaka-Akita H. Small-volume image-guided radiotherapy using hypofractionated, coplanar, and noncoplanar multiple fields for patients with inoperable Stage I nonsmall cell lung carcinomas. Cancer. 2002 Oct 1;95(7):1546-53. doi: 10.1002/cncr.10853.
- Lax I, Blomgren H, Naslund I, Svanstrom R. Stereotactic radiotherapy of malignancies in the abdomen. Methodological aspects. Acta Oncol. 1994;33(6):677-83. doi: 10.3109/02841869409121782.
- Blomgren H, Lax I, Naslund I, Svanstrom R. Stereotactic high dose fraction radiation therapy of extracranial tumors using an accelerator. Clinical experience of the first thirty-one patients. Acta Oncol. 1995;34(6):861-70. doi: 10.3109/02841869509127197.
- Schemper M, Smith TL. A note on quantifying follow-up in studies of failure time. Control Clin Trials. 1996 Aug;17(4):343-6. doi: 10.1016/0197-2456(96)00075-x. No abstract available.
- Krol AD, Aussems P, Noordijk EM, Hermans J, Leer JW. Local irradiation alone for peripheral stage I lung cancer: could we omit the elective regional nodal irradiation? Int J Radiat Oncol Biol Phys. 1996 Jan 15;34(2):297-302. doi: 10.1016/0360-3016(95)00227-8.
- Gauden SJ, Tripcony L. The curative treatment by radiation therapy alone of Stage I non-small cell lung cancer in a geriatric population. Lung Cancer. 2001 Apr;32(1):71-9. doi: 10.1016/s0169-5002(00)00199-9.
- Morita K, Fuwa N, Suzuki Y, Nishio M, Sakai K, Tamaki Y, Niibe H, Chujo M, Wada S, Sugawara T, Kita M. Radical radiotherapy for medically inoperable non-small cell lung cancer in clinical stage I: a retrospective analysis of 149 patients. Radiother Oncol. 1997 Jan;42(1):31-6. doi: 10.1016/s0167-8140(96)01828-2.
- Sirzen F, Kjellen E, Sorenson S, Cavallin-Stahl E. A systematic overview of radiation therapy effects in non-small cell lung cancer. Acta Oncol. 2003;42(5-6):493-515. doi: 10.1080/02841860310014453.
- Bradley JD, Wahab S, Lockett MA, Perez CA, Purdy JA. Elective nodal failures are uncommon in medically inoperable patients with Stage I non-small-cell lung carcinoma treated with limited radiotherapy fields. Int J Radiat Oncol Biol Phys. 2003 Jun 1;56(2):342-7. doi: 10.1016/s0360-3016(02)04614-x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SBRT CNPC
- ET2008-067
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