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

Non Small Cell Lung Cancer Clinical Trial

— SBRT-NSCLC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00870116
• Other study ID #: SBRT CNPC
• Secondary ID: ET2008-067
• Status: Active, not recruiting
• Phase: N/A
• First received: March 25, 2009
• Last updated: March 5, 2013
• Start date: April 2009
• Est. completion date: March 2013

Study information

• Verified date: February 2013
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Radiation:
• SBRT by cyberknife
treatment = 2x15 Gy during 2 weeks
• SBRT by linear accelerator
treatment = 2x15 Gy during 2 weeks
• Conformational radiotherapy
treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)

Locations

Country	Name	City	State
France	Centre Georges François Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
France	Centre Val d'Aurelle Paul Lamarque	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Hôpital Tenon	Paris
France	CHLS	Pierre Bénite
France	Centre René Gauducheau	Saint Herblain
France	Centre Alexis Vautrin	Vandoeuvre les Nancy

Sponsors (3)

Lead Sponsor	Collaborator
Centre Leon Berard	National Cancer Institute, France, The Biostatistics and Therapy Evaluation Unit

Country where clinical trial is conducted

France, 

References & Publications (23)

Blomgren H, Lax I, Näslund I, Svanström 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. — View Citation

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): — View Citation

Evaluation de la radiothérapie fractionnée en condition stéréotaxiques des métastases cérébrales, STIC 2005

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 Sta — View Citation

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. — View Citation

Hof H, Herfarth KK, Münter 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. — View Citation

Kaplan EL., MP. Nonparametric estimation from incomplete observations. 1958. J Am Stat Assoc 1958; 53:457-481

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. Review. — View Citation

Lax I, Blomgren H, Näslund I, Svanström R. Stereotactic radiotherapy of malignancies in the abdomen. Methodological aspects. Acta Oncol. 1994;33(6):677-83. — View Citation

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. Epub 2005 Aug 22. — View Citation

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. — View Citation

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 u — View Citation

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. Epub 2005 Jul 18. — View Citation

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 — View Citation

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

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

Sirzén F, Kjellén E, Sörenson S, Cavallin-Ståhl E. A systematic overview of radiation therapy effects in non-small cell lung cancer. Acta Oncol. 2003;42(5-6):493-515. Review. — View Citation

Timmerman R, Lohr F. Normal tissue Dose Constraints applied in lung stereotactic body radiation therapy. In Stereotactic Body Radiation Therapy, Pages 29-37; B.D. Kavanagh, R.D. Timmerman. Edts Lippicott Williams WilkinsSchemper M, Smith TL. A note on qua

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. — View Citation

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

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. — View Citation

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. — View Citation

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. Epub 2006 — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy		2 years	No
Secondary	Health economic evaluation of the various methods used for stereotactic radiotherapy		during treatment / post treatment	No
Secondary	Prospective evaluation of acute and late toxicities of SBRT		M1, M3, M6, M12, M18 and M24	No
Secondary	Study of quality of life in the 3 groups		inclusion, M1, M3, M12	No
Secondary	Evaluation of progression-free survival and overall survival in the 3 groups		No time	No