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Lung Cancer (NSCLC)Phase 2NCT06730295

Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer

A Phase 2 study testing Online adaptive SBRT in people with Lung Cancer (NSCLC), run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to explore the safety and efficacy of eliminating the PTV (planning target volume) margins based on online adaptive stereotactic radiotherapy for patients with centrally located early-stage non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer (NSCLC)
What is being tested?
Online adaptive SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
10 Dec 2024to 30 Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Histologically confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0), or recurrent disease (rT1-2N0M0) that is inoperable or where the patient is unwilling to undergo surgery.
  • Centrally located lung cancer.
  • Age 18 years or older, regardless of gender.
  • ECOG performance status score of 0-2.
  • Serum hemoglobin ≥ 80 g/L, platelets ≥ 100,000/μL, absolute neutrophil count ≥ 1,500/μL.
  • Serum creatinine ≤ 1.25 times the upper normal limit (UNL) or creatinine clearance ≥ 60 ml/min.
Show all 10Show fewer
  • Serum bilirubin ≤ 1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 times UNL, alkaline phosphatase ≤ 5 times UNL.
  • FEV1 ≥ 0.5 L.
  • Normal CB6 range.
  • The patient and their family agree and sign the informed consent form.

Who cannot join

  • Any other disease or condition that contraindicates radiotherapy (e.g., active infections, within 6 months post-myocardial infarction, symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmias).
  • Pregnant or breastfeeding women, women who have not undergone pregnancy testing, and pregnant individuals.
  • Individuals with substance abuse issues, chronic alcoholism, or AIDS.
  • Individuals with uncontrollable seizures or loss of self-control due to psychiatric disorders.
  • Individuals with a history of severe allergies or specific sensitivities.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

DaQuan Wang, Dr. contact

+862087343031

wangdq@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000

    Hui Liu, Doctor, +8687343657, liuhuisysucc@126.com

    Recruiting

Other trials in China

About this study

Official title: Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Centrally Located Early-stage Non-small Cell Lung Cancer: a Prospective, Single-arm, Phase II Study

This study aims to explore the safety and efficacy of eliminating the PTV (planning target volume) margins based on online adaptive stereotactic radiotherapy for patients with centrally located early-stage non-small cell lung cancer (NSCLC).

Being tested
Online adaptive SBRT
Keywords
lung cancer, radiotherapy, early stage
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online adaptive SBRTRadiation

    Online adaptive SBRT (without PTV expansion margin). The total dose will be 39-42Gy/3 fractions, administered once daily. FBCT and 4DCT will be acquired.

Study groups in NCT06730295
Study groupRoleWhat they receive
The study groupExperimentalPatients in the study group will receive online adaptive stereotactic body radiotherapy (without PTV expansion margin). The total dose will be 39-42Gy/3fractions, administered once daily. Both FBCT and 4DCT will be acquired before initiating treatment at each fraction.
Receives: Radiation: Online adaptive SBRT

What is being measured

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

  1. Incidence of grade 3 or higher SBRT-related toxicity

    Incidence of grade 3 or higher SBRT-related toxicity

    Measured: 1-year

Secondary outcomes (3)

  1. Objective response rate

    Objective Response Rate (ORR) is defined as the proportion of patients whose tumor size decreases to a pre-specified value and is maintained for a certain period of time during cancer treatment. It includes the number of patients with Complete Response (CR) and Partial Response (PR) as a percentage of the total number of evaluable cases.

    Measured: 2 months after radiotherapy]

  2. Local control rate

    The control of the local lesion after treatment.

    Measured: 2-year

  3. Progression-free survival

    PFS measures the time from the start date of SBRT to disease progression, death from any cause or last follow up if alive.

    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 posted12 Dec 2024
  2. Study start10 Dec 2024
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2028 (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
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06730295
Sponsor's protocol ID
GASTO-10122
Status last verified
Dec 2024
First submitted
9 Dec 2024
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Haasbeek CJ, Lagerwaard FJ, Slotman BJ, Senan S. Outcomes of stereotactic ablative radiotherapy for centrally located early-stage lung cancer. J Thorac Oncol. 2011 Dec;6(12):2036-43. doi: 10.1097/JTO.0b013e31822e71d8.

    PubMed 21892102

  • Meng Y, Luo W, Xu H, Wang W, Zhou S, Tang X, Li Z, Zhou C, Yang H. Adaptive intensity-modulated radiotherapy with simultaneous integrated boost for stage III non-small cell lung cancer: Is a routine adaptation beneficial? Radiother Oncol. 2021 May;158:118-124. doi: 10.1016/j.radonc.2021.02.019. Epub 2021 Feb 23.

    PubMed 33636232

  • Verma V, Shostrom VK, Kumar SS, Zhen W, Hallemeier CL, Braunstein SE, Holland J, Harkenrider MM, S Iskhanian A, Neboori HJ, Jabbour SK, Attia A, Lee P, Alite F, Walker JM, Stahl JM, Wang K, Bingham BS, Hadzitheodorou C, Decker RH, McGarry RC, Simone CB 2nd. Multi-institutional experience of stereotactic body radiotherapy for large (>/=5 centimeters) non-small cell lung tumors. Cancer. 2017 Feb 15;123(4):688-696. doi: 10.1002/cncr.30375. Epub 2016 Oct 14.

    PubMed 27741355

  • Bezjak A, Paulus R, Gaspar LE, Timmerman RD, Straube WL, Ryan WF, Garces YI, Pu AT, Singh AK, Videtic GM, McGarry RC, Iyengar P, Pantarotto JR, Urbanic JJ, Sun AY, Daly ME, Grills IS, Sperduto P, Normolle DP, Bradley JD, Choy H. Safety and Efficacy of a Five-Fraction Stereotactic Body Radiotherapy Schedule for Centrally Located Non-Small-Cell Lung Cancer: NRG Oncology/RTOG 0813 Trial. J Clin Oncol. 2019 May 20;37(15):1316-1325. doi: 10.1200/JCO.18.00622. Epub 2019 Apr 3.

    PubMed 30943123

  • Adebahr S, Collette S, Shash E, Lambrecht M, Le Pechoux C, Faivre-Finn C, De Ruysscher D, Peulen H, Belderbos J, Dziadziuszko R, Fink C, Guckenberger M, Hurkmans C, Nestle U. LungTech, an EORTC Phase II trial of stereotactic body radiotherapy for centrally located lung tumours: a clinical perspective. Br J Radiol. 2015 Jul;88(1051):20150036. doi: 10.1259/bjr.20150036. Epub 2015 Apr 15.

    PubMed 25873481

  • Sun B, Brooks ED, Komaki RU, Liao Z, Jeter MD, McAleer MF, Allen PK, Balter PA, Welsh JD, O'Reilly MS, Gomez D, Hahn SM, Roth JA, Mehran RJ, Heymach JV, Chang JY. 7-year follow-up after stereotactic ablative radiotherapy for patients with stage I non-small cell lung cancer: Results of a phase 2 clinical trial. Cancer. 2017 Aug 15;123(16):3031-3039. doi: 10.1002/cncr.30693. Epub 2017 Mar 27.

    PubMed 28346656

  • Prezzano KM, Ma SJ, Hermann GM, Rivers CI, Gomez-Suescun JA, Singh AK. Stereotactic body radiation therapy for non-small cell lung cancer: A review. World J Clin Oncol. 2019 Jan 10;10(1):14-27. doi: 10.5306/wjco.v10.i1.14.

    PubMed 30627522

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Online adaptive SBRT in people with Lung Cancer (NSCLC), run by Sun Yat-sen University 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 10 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 12 Mar 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact DaQuan Wang, Dr. (+862087343031, wangdq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of grade 3 or higher SBRT-related toxicity (time frame: 1-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 NCT06730295, which also lists 7 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 12 Mar 2025.

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