Clinical trial · Interventional
Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases
Elimination of PTV Margins Based on Online Adaptive Stereotactic Radiotherapy for Early-stage Non-small Cell Lung Cancer or Pulmonary Oligometastases: a Prospective, Randomized, Controlled Phase II Study
NCT06542159CI-TRIAL-00097322recruitingPhase 2ClinicalTrials.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)
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 early-stage non-small cell lung cancer (NSCLC) or pulmonary oligometastases.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adaptive Radiotherapy | — | UNRESOLVED | — |
| Lung Oligometastases | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Stereotactic Body Radiotherapy | — | UNRESOLVED | — |
| Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional SBRT | Radiation | — | UNRESOLVED |
| Online adaptive SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- The study group
- description
- Patients in the study group will receive online adaptive stereotactic body radiotherapy (without PTV expansion margin). The total dose will be 45-50Gy/3-4 fractions, administered once daily. Both FBCT and 4DCT will be acquired before initiating treatment at each fraction.
- interventionNames
- Radiation: Online adaptive SBRT
- type
- ACTIVE_COMPARATOR
- label
- The control group
- description
- Patients in the control group will receive conventional standard stereotactic body radiotherapy. The total dose will be 45-50Gy/3-4 fractions, administered once daily. CBCT will be acquired before initiating treatment at each fraction.
- interventionNames
- Radiation: Conventional SBRT
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or PET-CT confirmed untreated early-stage non-small cell lung cancer (T1-2N0M0) that is inoperable or where the patient is unwilling to undergo surgery, or PET-CT/chest CT confirmed lung oligometastases (number of metastases ≤3, single lesion diameter ≤5cm). * 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. Exclusion Criteria: * Tumors with bronchial invasion are excluded. * 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.
References
Publications (15)
- BACKGROUNDGanti AK, Klein AB, Cotarla I, Seal B, Chou E. Update of Incidence, Prevalence, Survival, and Initial Treatment in Patients With Non-Small Cell Lung Cancer in the US. JAMA Oncol. 2021 Dec 1;7(12):1824-1832. doi: 10.1001/jamaoncol.2021.4932. PMID 34673888
- BACKGROUNDPrezzano 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 30627522
- BACKGROUNDSun 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 28346656
- BACKGROUNDTimmerman RD, Hu C, Michalski JM, Bradley JC, Galvin J, Johnstone DW, Choy H. Long-term Results of Stereotactic Body Radiation Therapy in Medically Inoperable Stage I Non-Small Cell Lung Cancer. JAMA Oncol. 2018 Sep 1;4(9):1287-1288. doi: 10.1001/jamaoncol.2018.1258. PMID 29852036
- BACKGROUNDAdebahr 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 25873481
- BACKGROUNDRoach MC, Robinson CG, DeWees TA, Ganachaud J, Przybysz D, Drzymala R, Rehman S, Kashani R, Bradley JD. Stereotactic Body Radiation Therapy for Central Early-Stage NSCLC: Results of a Prospective Phase I/II Trial. J Thorac Oncol. 2018 Nov;13(11):1727-1732. doi: 10.1016/j.jtho.2018.07.017. Epub 2018 Jul 26.