- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02972229
Whole Versus Partial Vertebral Body IMRT for Spinal Metastases
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a prospective, randomized, single center, controlled explorative study in the parallel-group design to evaluate the difference in clinical outcomes for patients with metastatic spine disease treated with a whole versus partial vertebral body contouring approach. Thereby two different techniques were evaluated: whole vertebral body (WB) group with 10 x 3Gy or partial vertebral body (PB) group with 10x (3-5)Gy. Prior to their enrolment into the study, the patients will undergo a staging of the vertebral column in connection with their radiation-planning computed tomography (CT) and MRI to measure the myelon dimension. After the baseline results have been recorded, the patients will be randomized into one of the two groups: PB group RT 10x (3-5) Gy (n = 30) or WB group RT 10 x 3 Gy (n = 30). The target parameters will be measured and recorded at baseline, at 1 to 2 weeks; and at months 2 to 3, 4 to 6 and 7 to 12 after treatment.
The primary endpoint was the time to pain relief. Secondary endpoints were quality of life (QoL), fatigue, pain, overall survival, bone survival, local control, pathological fracture, pain-free internal and neurological deficit. The baseline examination shall be carried out on the first day of radiotherapy prior to the start of therapy and is scheduled to comprise the comprehensive recording of the sociodemographic data, the recording of the current pain situation, the quality of life, and the current degree of fatigue. The follow-up examinations shall take place at each follow up visit , measuring those parameters recorded at the baseline examination. The further follow-up examinations shall correspond to those carried out as standard after-care investigations.
The secondary endpoints such as fatigue and quality of life shall be recorded using validated questionnaires (EORTC QLQ FA13 and EORTC QLQ BM22. All patients will also be asked to record their pain history using a pain diary (documentation of medication daily during treatment, once weekly after the end of treatment, VAS pain scale). Furthermore, the local control was assessed by means of CT images taken prior to, three and six months after RT. The pain response was documented on the VAS (range 0-10). Complete response (CR) was defined as VAS = 0 after three and six months, partial response (PR) as an improvement by at least two score points after three and six months. Overall survival (OS) was defined as time from initial diagnosis until death, bone survival as time from initial diagnosis of spinal bone metastasis until death.
In each case, the treatment plan was designed based on tumor geometry, proximity to the spinal cord, and location. The planning tumor volume (PTV) was defined as equal to gross tumor volume (GTV). The spinal cord, cauda equina, nerve roots, and bowel were contoured as organs at risk (OARs) and critical structures. An inverse treatment planning method along with a linear optimization algorithm were employed. The target volume was designated to include either the GTV and the entire vertebral body (WB group) or only the GTV (PB group) at each spinal level.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with a histologically confirmed tumor diagnosis, with secondary -diagnosed solitary/multiple spinal bone metastases
- Indication for RT of the spinal bone metastases
- Maximal two irradiated vertebral-bodies per region
- Maximal two different vertebral regions
- Age: between 18 and 80 years
- Karnofsky index (10) ≥ 70
- Signed Declaration of Informed Consent
- Tumor distance > 3 mm to myelon
Exclusion Criteria:
- Multiple myeloma or lymphoma
- Significant neurological or psychiatric disorders, including dementia and epileptic seizures
- Earlier RT at the current irradiated site
- Other severe disorders that in the judgement of the study director may prevent the patient's participation in the study
- Lacking or diminished legal capacity
- Any medical of psychological condition that the study director considers a preventive factor for the patient's ability to complete the study or to adequately
- understand the scope of the study and to give his/her consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: partial body group
10x(3-5) Gy IMRT on partial vertebral body
|
10x(3-5) Gy IMRT on partial vertebral body for spinal metastases
|
Active Comparator: whole body group
10x3 Gy IMRT on whole vertebral body
|
10x3 Gy IMRT on whole vertebral body for spinal metastases
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the time to pain relief
Time Frame: 3 months after treatment
|
3 months after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 1 year
|
1 year
|
|
quality of life measured on an EORTC BM22 questionnaire
Time Frame: 3 and 6 months after therapy completed
|
3 and 6 months after therapy completed
|
|
local control
Time Frame: 3 months after therapy completed
|
local control as bone density is assessed 12 weeks post completion of radiotherapy using follow-up CT scan of the spine
|
3 months after therapy completed
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WuhanUH201610
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on 10x(3-5) Gy IMRT
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI); NRG OncologyCompletedSexual Dysfunction | Prostate Cancer | Radiation Toxicity | Psychosocial Effects of Cancer and Its TreatmentUnited States, Canada
-
Radiation Therapy Oncology GroupNational Cancer Institute (NCI)CompletedProstate CancerCanada, United States
-
Groupe Oncologie Radiotherapie Tete et CouCompletedOral Cancer | Oropharynx Cancer | Hypopharynx CancerFrance
-
Affiliated Hospital to Academy of Military Medical...UnknownRadiation Injuries, ExperimentalChina
-
Fundacao ChampalimaudCompleted
-
William Beaumont HospitalsTerminatedAlzheimer's DiseaseUnited States
-
Canadian Cancer Trials GroupTrans Tasman Radiation Oncology GroupCompletedSpinal MetastasesCanada, Australia
-
UMC UtrechtUnknownPancreatic CancerNetherlands
-
Weill Medical College of Cornell UniversityViewray Inc.RecruitingProstate CancerUnited States
-
Virginia Commonwealth UniversityTerminated