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Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

Primary Purpose

Breast Cancer, Prostate Cancer, Non Small Cell Lung Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Stereotactic Body Radiation Therapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring spinal metastases, Stereotactic body radiation therapy(SBRT), breast cancer, prostate cancer, non small cell lung cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

WHO scores 0-2;
The primary lesion was confirmed by pathology or cytology;
The metastatic lesions were diagnosed by imaging(CT,MRI,PET-CT,ECT),or the lesions were confirmed by biopsy;
The metastatic lesion was limited in 3 consecutive vertebral bodies;
The baseline pain score was ≥5(NRPS) and the use of analgesic drugs was recorded;
The enhanced MRI scan of involved vertebral bodies was required in the 2 weeks before radiotherapy;

Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:

Leukocytes ≥ 3.0 x109/ L;
Absolute neutrophil count (ANC) ≥ 1.5 x109/ L;
Platelet count ≥ 100 x109/ L;
Hemoglobin (Hb) ≥ 9g/ dL;
Total bilirubin ≤1.5 x the upper limit of normal (ULN);
Alanine aminotransferase (ALT) ≤ 3 x ULN;
Aspartate aminotransferase (AST) ≤ 3 x ULN;
Serum creatinine ≤ 1.5 x the ULN;
Signed informed consent;

Exclusion Criteria:

There were significant changes in the shape of the vertebral body (the height of the vertebral body was compressed≥ 50%) or the vertebral body was unchanged but the volume of the dissolving bone was≥ 50% and could lead to serious bone adverse events;
There were >3 consecutive vertebral bodies involved;
Spinal cord compression has occurred;
The gap between tumor and spinal cord was less than 3mm;
The metastatic area previously received radiation;
Pregnant and Nursing women;
Uncontrolled co-morbid illnesses;

9.refused to signed informed consent;

Sites / Locations

Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phase II open lable Study

Arm Description

Eligible patients will receive Stereotactic body radiation therapy (SBRT) for spinal metastatic lesion in 24Gy/3f(cervical vertebra) or 30Gy/3f (thoracic vertebra/lumbar vertebra) every other day and receive relevant system treatment at same time.

Outcomes

Primary Outcome Measures

The rate of relieve pain

According to the Numerical Rating Pain Scale (NRPS)

Secondary Outcome Measures

The degree of relieve pain

According to the Numerical Rating Pain Scale (NRPS)

The duration relieve pain

According to the Numerical Rating Pain Scale (NRPS)

The incidence of toxicity

Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Full Information

NCT ID

NCT03392233

First Posted

December 31, 2017

Last Updated

January 1, 2018

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03392233

Brief Title

Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

Official Title

A Phase II Study to Evaluated the Long-term of Safety and Efficacy of Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Recruiting

Study Start Date

August 18, 2017 (Actual)

Primary Completion Date

December 31, 2027 (Anticipated)

Study Completion Date

December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Stereotactic Body Radiation Therapy(SBRT) for spinal metastases has been proved a good results in pain relieve and local control, However,the longterm of efficacy and safety of this regimen is unclear.The purpose of the study is to evaluate the longterm outcome of this therapeutic regimen in selective patients who will be survival more than 2 years.

Detailed Description

Recently,Stereotactic Body Radiation Therapy(SBRT) become an alternative regimen for spinal metastases due to it's high dose cover the metastatic lesion and low dose in the adjacent spinal cord which result in more efficacy and less toxicity. However,the longterm of efficacy and safety of this regimen is unclear because of shortly median survival among unselective spinal metastases.To our knowledge,the median survival of some favorite metastatic diseases will be more than two years if they received appropriate system therapy.these include hormones dependent brest cancer/prostate cancer,and EGFR mutation non-small cell lung cancer(NSCLC) ect.The purpose of the study is to evaluate the longterm outcome of this therapeutic regimen in selective patients who will be survival more than 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Prostate Cancer, Non Small Cell Lung Cancer

Keywords

spinal metastases, Stereotactic body radiation therapy(SBRT), breast cancer, prostate cancer, non small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phase II open lable Study

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Body Radiation Therapy

Intervention Description

Primary Outcome Measure Information:

Title

The rate of relieve pain

Description

According to the Numerical Rating Pain Scale (NRPS)

Time Frame

One week after radiation to 2 years late

Secondary Outcome Measure Information:

Title

The degree of relieve pain

Description

According to the Numerical Rating Pain Scale (NRPS)

Time Frame

One week after radiation to 2 years late

Title

The duration relieve pain

Description

According to the Numerical Rating Pain Scale (NRPS)

Time Frame

One week after radiation to 2 years late

Title

The incidence of toxicity

Description

Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

Time Frame

One week after radiation to 2 years late

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: WHO scores 0-2; The primary lesion was confirmed by pathology or cytology; The metastatic lesions were diagnosed by imaging(CT,MRI,PET-CT,ECT),or the lesions were confirmed by biopsy; The metastatic lesion was limited in 3 consecutive vertebral bodies; The baseline pain score was ≥5(NRPS) and the use of analgesic drugs was recorded; The enhanced MRI scan of involved vertebral bodies was required in the 2 weeks before radiotherapy; Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: Leukocytes ≥ 3.0 x109/ L; Absolute neutrophil count (ANC) ≥ 1.5 x109/ L; Platelet count ≥ 100 x109/ L; Hemoglobin (Hb) ≥ 9g/ dL; Total bilirubin ≤1.5 x the upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 3 x ULN; Aspartate aminotransferase (AST) ≤ 3 x ULN; Serum creatinine ≤ 1.5 x the ULN; Signed informed consent; Exclusion Criteria: There were significant changes in the shape of the vertebral body (the height of the vertebral body was compressed≥ 50%) or the vertebral body was unchanged but the volume of the dissolving bone was≥ 50% and could lead to serious bone adverse events; There were >3 consecutive vertebral bodies involved; Spinal cord compression has occurred; The gap between tumor and spinal cord was less than 3mm; The metastatic area previously received radiation; Pregnant and Nursing women; Uncontrolled co-morbid illnesses; 9.refused to signed informed consent;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Ye, Master

Phone

+862168383459

renjiyeming@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Qi Lu, Master

Phone

+8621-58752345

Ext

33364

luqi@renji.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Ye, Master

Organizational Affiliation

Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Radiation Oncology,Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200127

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Ye, Master

Phone

+862168383459

renjiyeming@163.com

First Name & Middle Initial & Last Name & Degree

Qi Lu, Master

Phone

+862158752345

Ext

33364

luqi@renji.com

First Name & Middle Initial & Last Name & Degree

Ming Ye, Master

12. IPD Sharing Statement

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Stereotactic Body Radiation Therapy for Spinal Metastases in Favorite Tumors

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