- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02975609
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Non small-cell lung cancer (NSCLC) is the leading cause of cancer-related death worldwide. Approximately half of all patients with NSCLC present with metastatic disease at the time of diagnosis, and the predominant pattern of failure in patients with localized NSCLC is distant metastatic spread. The standard treatment in metastatic disease is cytotoxic chemotherapy with a mean overall survival between 8-11 months.
Various studies suggest that patients who clinically present with a limited number of metastases, a term defined as oligometastatic disease, could have a better prognosis of survival with a radical treatment, than for their counterparts with a greater number of metastasis. Much of the current clinical outcomes in oligometastatic disease is based on a series of the retrospective studies.
This is a randomised prospective phase II study based on patients with stage IV oligometastatic NSCLC according to UICC stage system(version 7,2009) or oligometastatic disease after radical operation for stage I-III NSCLC. The purpose of this study is to add more information to the current medical literature about the efficacy and safety of Stereotactic Body Radiation Therapy (SBRT) compared with conventional fractionated radiotherapy for oligometastatic non-small cell lung cancer (equal to or less than 5 sites and equal to or less than 5cm in maximum diameter).
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 two groups. The control group will undergo the conventional fractionated radiotherapy to all metastatic sites and the primary tumor. The experimental group will receive SBRT to primary lesions or metastatic lesions.
The investigators will compare progress free survival(PFS) ,overall survival, incidence of treatment-related adverse events of the two groups.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Shanghai
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Shanghai, Shanghai, Kina
- Shanghai Chest Hospital
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Conventional Fractionated Radiotherapy
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.
|
5Fx/W,3Gy/Fx,Dt:PTV-G:30Gy/10F/2W for metastatic sites, Dt:60Gy/30F for primary tumor and metastatic lymph node.
|
|
Eksperimentel: Stereotactic Body Radiation Therapy
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.
|
30Gy/3-5F for the primary and the metastases.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Fremskridt gratis overlevelse
Tidsramme: 2 år
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2 år
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Samlet overlevelse
Tidsramme: 2 år
|
2 år
|
|
Forekomst af behandlingsrelaterede bivirkninger
Tidsramme: 2 år
|
2 år
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Xiaolong Fu, Shanghai Chest Hospital
Publikationer og nyttige links
Generelle publikationer
- Salama 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.
- Hanna 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.
- Tree 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.
- Ashworth 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.
- Ashworth 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.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SCHLC008
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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