Non Small Cell Lung CancerSBRT-NSCLCNCT00870116
Stereotactic Body Radio Therapy (SBRT) for Early-stage Non Small Cell Lung Cancer (NSCLC)
A study testing SBRT by cyberknife, SBRT by linear accelerator and Conformational radiotherapy in people with Non Small Cell Lung Cancer, run by Centre Leon Berard at 9 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- SBRT by cyberknife, SBRT by linear accelerator and Conformational radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 9 sitesFrance
- Study dates
- Apr 2009to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Centre Georges François Leclerc
Dijon, 21000
Centre Oscar Lambret
Lille, 59000
Centre Leon Berard
Lyon, 69008
Centre Val d'Aurelle Paul Lamarque
Montpellier, 34000
Centre Antoine Lacassagne
Nice, 06000
Hôpital Tenon
Paris, 75012
CHLS
Pierre-Bénite, 69495
Centre René Gauducheau
Saint-Herblain, 44000
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, 54511
About this study
Official title: SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0
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.
Read the 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).
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- SBRT by cyberknife, SBRT by linear accelerator, Conformational radiotherapy
- Keywords
- SBRT, non-operated, non-metastatic, non-small-cell lung cancer, conformational radiotherapy, non-operated non-metastatic non-small-cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRT by cyberknifeRadiation
treatment = 2x15 Gy during 2 weeks
SBRT by linear acceleratorRadiation
treatment = 2x15 Gy during 2 weeks
Conformational radiotherapyRadiation
treatment = 5x2 Gy during 7 weeks (free breathing or breath holding)
| Study group | Role | What they receive |
|---|---|---|
| 1 - SBRT using cyberknife | Other | SBRT using cyberknife: treatment = 2x15 Gy during 2 weeks Receives: Radiation: SBRT by cyberknife |
| 2 - SBRT using linear accelerator | Other | SBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks Receives: Radiation: SBRT by linear accelerator |
| 3 - Conformational radiotherapy | Other | Conformational radiotherapy: treatment = 5x2 Gy during 7 weeks Receives: Radiation: Conformational radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy
Measured: 2 years
Secondary outcomes (4)
Health economic evaluation of the various methods used for stereotactic radiotherapy
Measured: during treatment / post treatment
Prospective evaluation of acute and late toxicities of SBRT
Measured: M1, M3, M6, M12, M18 and M24
Study of quality of life in the 3 groups
Measured: inclusion, M1, M3, M12
Evaluation of progression-free survival and overall survival in the 3 groups
Measured: No time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- The Biostatistics and Therapy Evaluation Unit, National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- Line CLAUDE, MD, Principal investigator, Centre Léon Bérard, Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870116
- Sponsor's protocol ID
- SBRT CNPC
- Other IDs
- ET2008-067
- Acronym
- SBRT-NSCLC
- Status last verified
- Feb 2013
- First submitted
- 25 Mar 2009
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16024180Kaplan 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
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.
PubMed 14605072McGarry 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.
PubMed 16115740Whyte 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.
PubMed 12683544Xia 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.
PubMed 16765528Nagata 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.
PubMed 16169670Onishi 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.
PubMed 15378503Hof 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.
PubMed 12738306Uematsu 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.
PubMed 11597807Fukumoto 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.
PubMed 12237924
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SBRT Radiotherapy for Non-operated Non-small-cell Lung Cancer (NSCLC), T1-T2, N0, M0
- ClinicalTrials.gov ID
- NCT00870116
- Acronym / sponsor ID
- SBRT-NSCLC / SBRT CNPC
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- The Biostatistics and Therapy Evaluation Unit, National Cancer Institute, France
- Study start
- Apr 2009
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 - SBRT using cyberknife | Other | Radiation: SBRT by cyberknifeSBRT using cyberknife: treatment = 2x15 Gy during 2 weeks |
| 2 - SBRT using linear accelerator | Other | Radiation: SBRT by linear acceleratorSBRT using linear accelerator: treatment = 2x15 Gy during 2 weeks |
| 3 - Conformational radiotherapy | Other | Radiation: Conformational radiotherapyConformational radiotherapy: treatment = 5x2 Gy during 7 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Non-operated non-small-cell lung cancer (NSCLC) (inoperable tumor or patient refusal of surgery)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRT by cyberknifetreatment = 2x15 Gy during 2 weeks | Radiation | 1 - SBRT using cyberknife |
| SBRT by linear acceleratortreatment = 2x15 Gy during 2 weeks | Radiation | 2 - SBRT using linear accelerator |
| Conformational radiotherapytreatment = 5x2 Gy during 7 weeks (free breathing or breath holding) | Radiation | 3 - Conformational radiotherapy |
Primary outcome
Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy
Time frame: 2 years
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
- Background: PubMed 16024180Noel 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.
- 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
- Results publicationEvaluation de la radiothérapie fractionnée en condition stéréotaxiques des métastases cérébrales, STIC 2005
- Results publicationTschung 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 publication: PubMed 14605072Timmerman 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 publication: PubMed 16115740McGarry 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 publication: PubMed 12683544Whyte 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 publication: PubMed 16765528Xia 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 publication: PubMed 16169670Nagata 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 publication: PubMed 15378503Onishi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Line CLAUDE, MD principal investigator
Centre Léon Bérard, Lyon
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SBRT by cyberknife, SBRT by linear accelerator and Conformational radiotherapy in people with Non Small Cell Lung Cancer, run by Centre Leon Berard at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of local control in patients with non-operated, non-metastatic non-small-cell lung cancer treated by radiotherapy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00870116, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2013.