search
Back to results

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

Primary Purpose

Non Small Cell Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SBRT by cyberknife
SBRT by linear accelerator
Conformational radiotherapy
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring SBRT, non-operated, non-metastatic, non-small-cell lung cancer, conformational radiotherapy, non-operated non-metastatic non-small-cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Georges François Leclerc
  • Centre Oscar Lambret
  • Centre Leon Berard
  • Centre Val d'Aurelle Paul Lamarque
  • Centre Antoine Lacassagne
  • Hôpital Tenon
  • CHLS
  • Centre René Gauducheau
  • Centre Alexis Vautrin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

1 - SBRT using cyberknife

2 - SBRT using linear accelerator

3 - Conformational radiotherapy

Arm Description

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

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

Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks

Outcomes

Primary Outcome Measures

Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy

Secondary Outcome Measures

Health economic evaluation of the various methods used for stereotactic radiotherapy
Prospective evaluation of acute and late toxicities of SBRT
Study of quality of life in the 3 groups
Evaluation of progression-free survival and overall survival in the 3 groups

Full Information

First Posted
March 25, 2009
Last Updated
March 5, 2013
Sponsor
Centre Leon Berard
Collaborators
The Biostatistics and Therapy Evaluation Unit, National Cancer Institute, France
search

1. Study Identification

Unique Protocol Identification Number
NCT00870116
Brief Title
Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC)
Acronym
SBRT-NSCLC
Official Title
SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
Collaborators
The Biostatistics and Therapy Evaluation Unit, National Cancer Institute, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
SBRT, non-operated, non-metastatic, non-small-cell lung cancer, conformational radiotherapy, non-operated non-metastatic non-small-cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 - SBRT using cyberknife
Arm Type
Other
Arm Description
SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks
Arm Title
2 - SBRT using linear accelerator
Arm Type
Other
Arm Description
SBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks
Arm Title
3 - Conformational radiotherapy
Arm Type
Other
Arm Description
Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks
Intervention Type
Radiation
Intervention Name(s)
SBRT by cyberknife
Intervention Description
treatment = 2x15 Gy during 2 weeks
Intervention Type
Radiation
Intervention Name(s)
SBRT by linear accelerator
Intervention Description
treatment = 2x15 Gy during 2 weeks
Intervention Type
Radiation
Intervention Name(s)
Conformational radiotherapy
Intervention Description
treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)
Primary Outcome Measure Information:
Title
Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Health economic evaluation of the various methods used for stereotactic radiotherapy
Time Frame
during treatment / post treatment
Title
Prospective evaluation of acute and late toxicities of SBRT
Time Frame
M1, M3, M6, M12, M18 and M24
Title
Study of quality of life in the 3 groups
Time Frame
inclusion, M1, M3, M12
Title
Evaluation of progression-free survival and overall survival in the 3 groups
Time Frame
No time

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line CLAUDE, MD
Organizational Affiliation
Centre Léon Bérard, LYON
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Val d'Aurelle Paul Lamarque
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Hôpital Tenon
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
CHLS
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44000
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre les Nancy
ZIP/Postal Code
54511
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16024180
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. doi: 10.1016/j.ijrobp.2005.04.037. Epub 2005 Jul 18.
Results Reference
background
Citation
Kaplan EL., MP. Nonparametric estimation from incomplete observations. 1958. J Am Stat Assoc 1958; 53:457-481
Results Reference
background
Citation
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
Results Reference
background
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
Results Reference
background
Citation
Evaluation de la radiothérapie fractionnée en condition stéréotaxiques des métastases cérébrales, STIC 2005
Results Reference
result
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
Results Reference
result
PubMed Identifier
14605072
Citation
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.
Results Reference
result
PubMed Identifier
16115740
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. doi: 10.1016/j.ijrobp.2005.03.073. Epub 2005 Aug 22.
Results Reference
result
PubMed Identifier
12683544
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. doi: 10.1016/s0003-4975(02)04681-7.
Results Reference
result
PubMed Identifier
16765528
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. doi: 10.1016/j.ijrobp.2006.04.013. Epub 2006 Jun 9.
Results Reference
result
PubMed Identifier
16169670
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 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.
Results Reference
result
PubMed Identifier
15378503
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 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.
Results Reference
result
PubMed Identifier
12738306
Citation
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.
Results Reference
result
PubMed Identifier
11597807
Citation
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.
Results Reference
result
PubMed Identifier
12237924
Citation
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.
Results Reference
result
PubMed Identifier
7946448
Citation
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.
Results Reference
result
PubMed Identifier
7576756
Citation
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.
Results Reference
result
PubMed Identifier
8889347
Citation
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.
Results Reference
result
PubMed Identifier
8567329
Citation
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.
Results Reference
result
PubMed Identifier
11282431
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. doi: 10.1016/s0169-5002(00)00199-9.
Results Reference
result
PubMed Identifier
9132823
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. 1997 Jan;42(1):31-6. doi: 10.1016/s0167-8140(96)01828-2.
Results Reference
result
PubMed Identifier
14596509
Citation
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.
Results Reference
result
PubMed Identifier
12738307
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):342-7. doi: 10.1016/s0360-3016(02)04614-x.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs