Phase II Trial of SBRT Compared With Conventional Radiotherapy for Oligometastatic Non-Small Cell Lung Cancer

NCT02975609 | Unknown Phase 2 DMC

• 1 other identifier: SCHLC008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

NSCLC

Outcome Measures

Primary Outcomes (1)

• Progress Free Survival

  2 years

Secondary Outcomes (2)

• Overall Survival

  2 years

• Incidence of treatment-related adverse events

  2 years

Study Arms (2)

Conventional Fractionated Radiotherapy

ACTIVE COMPARATOR

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.

Radiation: Conventional Fractionated Radiotherapy

Stereotactic Body Radiation Therapy

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiation Therapy

Interventions

Conventional Fractionated Radiotherapy RADIATION

5Fx/W,3Gy/Fx,Dt:PTV-G:30Gy/10F/2W for metastatic sites, Dt:60Gy/30F for primary tumor and metastatic lymph node.

Conventional Fractionated Radiotherapy

Stereotactic Body Radiation Therapy RADIATION

30Gy/3-5F for the primary and the metastases.

Stereotactic Body Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (5)

• 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.

  PMID: 25948377 BACKGROUND

• 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.

  PMID: 25770653 BACKGROUND

• 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.

  PMID: 23276369 BACKGROUND

• 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.

  PMID: 24051084 BACKGROUND

• 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.

  PMID: 24894943 BACKGROUND

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Xiaolong Fu

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaolong Fu, doctor

CONTACT

+862122200000; xlfu1964@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Radiation Oncology

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: November 29, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: November 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)