Whole Versus Partial Vertebral Body IMRT for Spinal Metastases

Pain Clinical Trial

Official title:

Whole Versus Partial Vertebral Body IMRT for Spinal Metastases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02972229
• Other study ID #: WuhanUH201610
• Status: Not yet recruiting
• Phase: N/A
• First received: November 16, 2016
• Last updated: November 22, 2016
• Start date: November 2016
• Est. completion date: November 2019

Study information

• Verified date: November 2016
• Source: Wuhan Union Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Hubei Province
• Study type: Interventional

Clinical Trial Summary

To compare the treatment effect and toxicity between Intensity-Modulated Radiation therapy for whole metastatic vertebral body and simple metastatic lesions of vertebra in metastatic spinal tumors

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Radiation:
• 10x(3-5) Gy IMRT
10x(3-5) Gy IMRT on partial vertebral body for spinal metastases
• 10x3 Gy IMRT
10x3 Gy IMRT on whole vertebral body for spinal metastases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time to pain relief		3 months after treatment	Yes
Secondary	quality of life measured on an EORTC BM22 questionnaire		3 and 6 months after therapy completed	Yes
Secondary	Overall survival		1 year	Yes
Secondary	local control	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	Yes