Clinical trial · Interventional
Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC)
SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0
NCT00870116CI-TRIAL-00009657SBRT-NSCLCunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conformational radiotherapy | Radiation | — | UNRESOLVED |
| SBRT by cyberknife | Radiation | — | UNRESOLVED |
| SBRT by linear accelerator | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- 1 - SBRT using cyberknife
- description
- SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks
- interventionNames
- Radiation: SBRT by cyberknife
- type
- OTHER
- label
- 2 - SBRT using linear accelerator
- description
- SBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks
- interventionNames
- Radiation: SBRT by linear accelerator
- type
- OTHER
- label
- 3 - Conformational radiotherapy
- description
- Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (23)
- BACKGROUNDNoel 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. PMID 16024180
- BACKGROUNDKaplan EL., MP. Nonparametric estimation from incomplete observations. 1958. J Am Stat Assoc 1958; 53:457-481
- BACKGROUNDPommier 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
- BACKGROUNDPommier 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
- RESULTEvaluation de la radiothérapie fractionnée en condition stéréotaxiques des métastases cérébrales, STIC 2005
- RESULTTschung 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
- RESULTTimmerman 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. PMID 14605072
- RESULTMcGarry 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. PMID 16115740
- RESULTWhyte 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.