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

Sponsor:	Centre Leon Berard
Collaborators:	UBET (Unité de Biostatistiques et d'Evaluation des Thérapeutiques - C. L. Bérard) National Cancer Institute, France
Information provided by:	Centre Leon Berard
ClinicalTrials.gov Identifier:	NCT00870116

Purpose

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	Intervention
Non Small Cell Lung Cancer	Radiation: SBRT by cyberknife Radiation: SBRT by linear accelerator Radiation: Conformational radiotherapy

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:

Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Health economic evaluation of the various methods used for stereotactic radiotherapy [ Time Frame: during treatment / post treatment ] [ Designated as safety issue: No ]
Prospective evaluation of acute and late toxicities of SBRT [ Time Frame: M1, M3, M6, M12, M18 and M24 ] [ Designated as safety issue: No ]
Study of quality of life in the 3 groups [ Time Frame: inclusion, M1, M3, M12 ] [ Designated as safety issue: No ]
Evaluation of progression-free survival and overall survival in the 3 groups [ Time Frame: No time ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2009
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 - SBRT using cyberknife SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks	Radiation: SBRT by cyberknife treatment = 2x15 Gy during 2 weeks
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
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)

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870116

Locations

France
Centre Georges François Leclerc
Dijon, France, 21000
Centre Oscar Lambret
Lille, France, 59000
Centre Leon Berard
Lyon, France, 69008
Centre Val d'Aurelle Paul Lamarque
Montpellier, France, 34000
Centre Antoine Lacassagne
Nice, France, 06000
Hôpital Tenon
Paris, France, 75012
CHLS
Pierre Bénite, France, 69495
Centre René Gauducheau
Saint Herblain, France, 44000
Centre Alexis Vautrin
Vandoeuvre les Nancy, France, 54511

Sponsors and Collaborators

Centre Leon Berard

UBET (Unité de Biostatistiques et d'Evaluation des Thérapeutiques - C. L. Bérard)

National Cancer Institute, France

Investigators

Principal Investigator:

Line CLAUDE, MD

Centre Léon Bérard, LYON

More Information

Publications:

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.

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.

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.

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 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 Sep 15; [Epub ahead of print]

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.

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.

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.

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.

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

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.

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 quantifying follow-up in studies of failure time. Control Clin Trials 1996; 17(4):343-346.

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.

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.

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.

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.

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.

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.

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

Responsible Party:	Zora ABDELBOST, Centre Léon Bérard, 28 rue Laënnec, 69373 LYON Cedex 08, FRANCE
ClinicalTrials.gov Identifier:	NCT00870116 History of Changes
Other Study ID Numbers:	SBRT CNPC, ET2008-067
Study First Received:	March 25, 2009
Last Updated:	February 13, 2012
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre Leon Berard:

SBRT
non-operated
non-metastatic

non-small-cell lung cancer
conformational radiotherapy
non-operated non-metastatic non-small-cell lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2012