NCT06730295

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
31mo left

Started Dec 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress35%
Dec 2024Nov 2028

First Submitted

Initial submission to the registry

December 9, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

December 10, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

March 12, 2025

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

December 9, 2024

Last Update Submit

March 9, 2025

Conditions

Lung Cancer (NSCLC)

Keywords

lung cancerradiotherapyearly stage

Outcome Measures

Primary Outcomes (1)

  • Incidence of grade 3 or higher SBRT-related toxicity

    Incidence of grade 3 or higher SBRT-related toxicity

    1-year

Secondary Outcomes (3)

  • Objective response rate

    2 months after radiotherapy]

  • Local control rate

    2-year

  • Progression-free survival

    2-year

Study Arms (1)

The study group

EXPERIMENTAL

Patients 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.

Radiation: Online adaptive SBRT

Interventions

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.

The study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (7)

  • 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.

    PMID: 21892102BACKGROUND

  • 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.

    PMID: 33636232BACKGROUND

  • 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.

    PMID: 27741355BACKGROUND

  • 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.

    PMID: 30943123BACKGROUND

  • 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.

    PMID: 25873481BACKGROUND

  • 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.

    PMID: 28346656BACKGROUND

  • 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.

    PMID: 30627522BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Central Study Contacts

DaQuan Wang, Dr.

CONTACT

+862087343031wangdq@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pro.

Study Record Dates

First Submitted

December 9, 2024

First Posted

December 12, 2024

Study Start

December 10, 2024

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2028

Last Updated

March 12, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)