Clinical trial · Interventional
Phase II Trial of SBRT Compared With Conventional Radiotherapy for Oligometastatic Non-Small Cell Lung Cancer
Phase II Trial of Stereotactic Body Radiation Therapy Compared With Conventional Fractionated Radiotherapy for Oligometastatic Non-Small Cell Lung Cancer
NCT02975609CI-TRIAL-00024934unknownPhase 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 protocol is a phase II randomized controlled trial (RCT) evaluating the efficacy of SBRT compared with conventional fractionated radiotherapy for oligometastatic Non-Small Cell Lung Cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Fractionated Radiotherapy | Radiation | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional Fractionated Radiotherapy
- description
- The patients enrolled receive firstly 4-6 cycles chemotherapy (platinum-based doublet chemotherapy), and achieve response(stable disease or partial response or complete response). Patients will be randomized into the control group undergoing the conventional fractionated radiotherapy to all metastatic sites and the primary tumor.
- interventionNames
- Radiation: Conventional Fractionated Radiotherapy
- type
- EXPERIMENTAL
- label
- Stereotactic Body Radiation Therapy
- description
- The patients enrolled receive firstly 4-6 cycles chemotherapy (platinum-based doublet chemotherapy), and achieve response(stable disease or partial response or complete response). Patients will be randomized into the experimental group undergoing SBRT to all metastatic sites and the primary tumor.
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven non-small-cell lung cancer. * Stage IV oligometastatic NSCLC according to UICC stage system(version 7,2009) or oligometastatic disease after radical operation for stage I-III NSCLC. * The patients receive firstly 4-6 cycles chemotherapy (platinum-based doublet chemotherapy), and achieve response(stable disease or partial response or complete response). * Staging with chest CT scan, abdominal ultrasonography , MRI brain, Bone scan and/or FDG PET-CT whole body scan. * Number of metastatic lesions equal to or less than 5. * Maximum diameter of metastatic tumors equal to or less than 5cm. * ECOG performance status 0-2 at time of registration. * EGFR testing is mandatory. * No brain metastasis in MRI. * No liver metastasis in abdominal CT or MRI. * No malignant pleural effusion or pericardial effusion or peritoneal effusion. * Acceptable lung function for radical lung radiotherapy. * Stable lab values: Hematological: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin≥9 g/dL Renal: Creatinine OR Measured or calculated creatinine clearance (CrCl)(glomerular filtration rate \[GFR\] can also be used in place of creatinine or CrCl) ≤1.5×the upper limit of normal (ULN) OR ≥60 mL/min for patient with creatinine levels\>1.5× institutional ULN Hepatic: Total bilirubin ≤1.5×ULN OR Direct bilirubin ≤ULN for patients with total bilirubin levels \>1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN,globulin≥20 g/L, albumin≥30 g/L. * No relevant co-morbidities, including pulmonary fibrosis and connective tissue disorders * Able to understand and give written informed consent and comply with study procedures. Exclusion Criteria: * Patient has had palliative radiotherapy to any tumour site prior to registration and/or requires palliative radiotherapy prior to randomisation. * Patient has received any molecular targeted therapeutic drugs for NSCLC malignancy. * The patients receive firstly 4-6 cycles chemotherapy (platinum-based doublet chemotherapy), and achieve progressive disease. * Any unstable systemic disease, including active infection, uncontrolled high blood pressure, unstable angina, newly observed angina pectoris within the past 3 months, congestive heart failure (New York heart association (NYHA) class II or higher), myocardial infarction onset six months before included into the group, and severe arrhythmia, liver, kidney, or metabolic disease in need of drug therapy. * Previously diagnosed with immunodeficiency disease. * Human immunodeficiency virus (HIV) infection. * Women in pregnancy or lactation. * Patients with mental illness, considered as "can't fully understand the issues of this research". * other Cancer history. * Histologically confirmed small cell carcinoma or other non NSCLC compositions in the cancer tissue. * Brain metastasis or liver metastasis or malignant pleural effusion or pericardial effusion or peritoneal effusion.
References
Publications (5)
- BACKGROUNDSalama JK, Schild SE. Radiation therapy for oligometastatic non-small cell lung cancer. Cancer Metastasis Rev. 2015 Jun;34(2):183-93. doi: 10.1007/s10555-015-9559-z. PMID 25948377
- BACKGROUNDHanna GG, Landau D. Stereotactic body radiotherapy for oligometastatic disease. Clin Oncol (R Coll Radiol). 2015 May;27(5):290-7. doi: 10.1016/j.clon.2015.02.003. Epub 2015 Mar 12. PMID 25770653
- BACKGROUNDTree AC, Khoo VS, Eeles RA, Ahmed M, Dearnaley DP, Hawkins MA, Huddart RA, Nutting CM, Ostler PJ, van As NJ. Stereotactic body radiotherapy for oligometastases. Lancet Oncol. 2013 Jan;14(1):e28-37. doi: 10.1016/S1470-2045(12)70510-7. PMID 23276369
- BACKGROUNDAshworth A, Rodrigues G, Boldt G, Palma D. Is there an oligometastatic state in non-small cell lung cancer? A systematic review of the literature. Lung Cancer. 2013 Nov;82(2):197-203. doi: 10.1016/j.lungcan.2013.07.026. Epub 2013 Aug 20. PMID 24051084
- BACKGROUNDAshworth AB, Senan S, Palma DA, Riquet M, Ahn YC, Ricardi U, Congedo MT, Gomez DR, Wright GM, Melloni G, Milano MT, Sole CV, De Pas TM, Carter DL, Warner AJ, Rodrigues GB. An individual patient data metaanalysis of outcomes and prognostic factors after treatment of oligometastatic non-small-cell lung cancer. Clin Lung Cancer. 2014 Sep;15(5):346-55. doi: 10.1016/j.cllc.2014.04.003. Epub 2014 May 15. PMID 24894943