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Non-Small Cell Lung CancerPhase 2NCT02584699

Study of Stereotactic Ablative Radiotherapy (SABR) in Elderly Stage I NSCLC

A Phase 2 study testing Stereotactic Ablative Radiotherapy (SABR) in people with Non-Small Cell Lung Cancer, run by Luhua Wang at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to prospectively investigate the efficacy, toxicity and quality of life (QOF) of stereotactic ablative radiotherapy (SABR) using a moderate fractionation of 72 Gy/6 Gy/12 F (BED10 = 115 Gy) in a single arm of elderly ( ≥ 70) patients with stage I (2009 UICC) non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Stereotactic Ablative Radiotherapy (SABR)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
Jul 2015to Jul 2018
Phase
Phase 2
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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age ≥ 70
  • Pathologically or cytologically confirmed NSCLC
  • Stage T1- 2 N0M0 based on adequate workup
  • Peripheral tumor
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Inoperable NSCLC

Who cannot join

  • Pathologically or cytologically confirmed SCLC
  • Direct evidence of regional or distant metastasis
  • Central tumor
  • Past history of malignancy
  • Past history of thoracic irradiation
  • Past history of chemotherapy
Show all 10Show fewer
  • Past history of thoracic surgery
  • Pure Bronchioalveolar adenocarcinoma
  • Active systemic, pulmonary or pleural lung diseases
  • Pulmonary infection

Trial locations and contacts

1 site in 1 country.

Jingbo Wang, Dr. contact

8610-87788503

wangjingbo303@yahoo.com

Luhua Wang, Dr. contact

8610-87788799

wlhwq@yahoo.com

China1 site, 1 recruiting

  • Cancer Hospital/Institute, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Jingbo Wang, Dr., 8610-87788503, wangjingbo303@yahoo.com

    Luhua Wang, Dr., 8610-87788799, wlhwq@yahoo.com

    Recruiting

Other trials in China

About this study

Official title: Phase II Study of Stereotactic Ablative Radiotherapy in Elderly Patients With Stage I Non-Small Cell Lung Cancer

This study aims to prospectively investigate the efficacy, toxicity and quality of life (QOF) of stereotactic ablative radiotherapy (SABR) using a moderate fractionation of 72 Gy/6 Gy/12 F (BED10 = 115 Gy) in a single arm of elderly ( ≥ 70) patients with stage I (2009 UICC) non-small cell lung cancer (NSCLC).

Read the detailed description

This study aims to prospectively investigate the local regional control, overall survival, treatment related toxicities and quality of life (QOF) of elderly stage I NSCLC patients receiving stereotactic ablative radiotherapy (SABR) with a moderate fractionation of 72 Gy/6 Gy/12 F (BED10 = 115 Gy). Patients' general characteristics, treatment modality, dose-volume histogram (DVH) parameters, toxicity profiling, quality of life, pattern of failure as well as survival time will be prospective recorded for the analysis.

Being tested
Stereotactic Ablative Radiotherapy (SABR)
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.

  • Stereotactic Ablative Radiotherapy (SABR)Radiation

    Also called Stereotactic body radiation therapy (SBRT)

    Six Gy irradiation per fraction times 12 fractionations, resulting a total dose of 72Gy

Study groups in NCT02584699
Study groupRoleWhat they receive
SABRExperimentalSABR group includes patients receiving pre-identified fractionated Stereotactic Ablative Radiotherapy (SABR)
Receives: Radiation: Stereotactic Ablative Radiotherapy (SABR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local regional progression free survival

    Duration between radiotherapy commencement and local progression, regional progression, death of cancer or last date of follow up.

    Measured: 2 year

Secondary outcomes (5)

  1. Objective response rate

    Tumor response to radiotherapy evaluated by RECIST 1.1

    Measured: 1 month after RT

  2. Progression free survival

    Duration between radiotherapy commencement and any progression, death of cancer or last date of follow up.

    Measured: 2 year

  3. Overall survival

    Duration between radiotherapy commencement and any cause of death or last date of follow up.

    Measured: 2 year

  4. Grade ≥ 2 radiation induced normal tissue toxicity

    Incidence of radiation induced toxicities on lung, oesophagus, rib or chest wall pain assessed by CTCAE v 4.0

    Measured: 1 year

  5. Questionnaire on quality of life

    Physical and psychologic status assessed by specific questionnaire

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionJul 2018 (estimated)
  4. Study completionJul 2018 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02584699
Sponsor's protocol ID
33320140105
Status last verified
Oct 2015
First submitted
13 Aug 2015
Last updated
23 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Havlik RJ, Yancik R, Long S, Ries L, Edwards B. The National Institute on Aging and the National Cancer Institute SEER collaborative study on comorbidity and early diagnosis of cancer in the elderly. Cancer. 1994 Oct 1;74(7 Suppl):2101-6. doi: 10.1002/1097-0142(19941001)74:7+3.0.co;2-m.

    PubMed 8087777

  • Yang L, Li L, Chen Y, Parkin DM. [Mortality time trends and the incidence and mortality estimation and projection for lung cancer in China]. Zhongguo Fei Ai Za Zhi. 2005 Aug 20;8(4):274-8. doi: 10.3779/j.issn.1009-3419.2005.04.05. Chinese.

    PubMed 21108881

  • Wingo PA, Cardinez CJ, Landis SH, Greenlee RT, Ries LA, Anderson RN, Thun MJ. Long-term trends in cancer mortality in the United States, 1930-1998. Cancer. 2003 Jun 15;97(12 Suppl):3133-275. doi: 10.1002/cncr.11380.

    PubMed 12784323

  • Raz DJ, Zell JA, Ou SH, Gandara DR, Anton-Culver H, Jablons DM. Natural history of stage I non-small cell lung cancer: implications for early detection. Chest. 2007 Jul;132(1):193-9. doi: 10.1378/chest.06-3096. Epub 2007 May 15.

    PubMed 17505036

  • Rowell NP, Williams CJ. Radical radiotherapy for stage I/II non-small cell lung cancer in patients not sufficiently fit for or declining surgery (medically inoperable): a systematic review. Thorax. 2001 Aug;56(8):628-38. doi: 10.1136/thorax.56.8.628.

    PubMed 11462066

  • Dosoretz DE, Galmarini D, Rubenstein JH, Katin MJ, Blitzer PH, Salenius SA, Dosani RA, Rashid M, Mestas G, Hannan SE, et al. Local control in medically inoperable lung cancer: an analysis of its importance in outcome and factors determining the probability of tumor eradication. Int J Radiat Oncol Biol Phys. 1993 Oct 20;27(3):507-16. doi: 10.1016/0360-3016(93)90373-4.

    PubMed 8226142

  • Timmerman R, Paulus R, Galvin J, Michalski J, Straube W, Bradley J, Fakiris A, Bezjak A, Videtic G, Johnstone D, Fowler J, Gore E, Choy H. Stereotactic body radiation therapy for inoperable early stage lung cancer. JAMA. 2010 Mar 17;303(11):1070-6. doi: 10.1001/jama.2010.261.

    PubMed 20233825

  • Senthi S, Lagerwaard FJ, Haasbeek CJ, Slotman BJ, Senan S. Patterns of disease recurrence after stereotactic ablative radiotherapy for early stage non-small-cell lung cancer: a retrospective analysis. Lancet Oncol. 2012 Aug;13(8):802-9. doi: 10.1016/S1470-2045(12)70242-5. Epub 2012 Jun 22.

    PubMed 22727222

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Stereotactic Ablative Radiotherapy (SABR) in people with Non-Small Cell Lung Cancer, run by Luhua Wang at 1 site in China.

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 6 inclusion and 10 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 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Jingbo Wang, Dr. (8610-87788503, wangjingbo303@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local regional progression free survival (time frame: 2 year). 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 NCT02584699, which also lists 8 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 23 Oct 2015.

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