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

Overview

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.

Full Title of Study: “SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

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).

Interventions

  • Radiation: SBRT by cyberknife
    • treatment = 2×15 Gy during 2 weeks
  • Radiation: SBRT by linear accelerator
    • treatment = 2×15 Gy during 2 weeks
  • Radiation: Conformational radiotherapy
    • treatment = 5×2 Gy during 7 weeks (free breathing or breath holding)

Arms, Groups and Cohorts

  • Other: 1 – SBRT using cyberknife
    • SBRT using cyberknife: treatment = 2×15 Gy during 2 weeks
  • Other: 2 – SBRT using linear accelerator
    • SBRT using linear accelerator: treatment = 2×15 Gy during 2 weeks
  • Other: 3 – Conformational radiotherapy
    • Conformational radiotherapy: treatment = 5×2 Gy during 7 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy
    • Time Frame: 2 years

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Leon Berard
  • Collaborator
    • The Biostatistics and Therapy Evaluation Unit
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Line CLAUDE, MD, Principal Investigator, Centre Léon Bérard, LYON

References

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

Citations Reporting on Results

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.