Whole Versus Partial Vertebral Body IMRT for Spinal Metastases

NCT02972229 | Unknown DMC

• 1 other identifier: WuhanUH201610
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• the time to pain relief

  3 months after treatment

Secondary Outcomes (3)

• quality of life measured on an EORTC BM22 questionnaire

  3 and 6 months after therapy completed

• Overall survival

  1 year

• local control

  3 months after therapy completed

Study Arms (2)

partial body group

EXPERIMENTAL

10x(3-5) Gy IMRT on partial vertebral body

Radiation: 10x(3-5) Gy IMRT

whole body group

ACTIVE COMPARATOR

10x3 Gy IMRT on whole vertebral body

Radiation: 10x3 Gy IMRT

Interventions

10x(3-5) Gy IMRT RADIATION

10x(3-5) Gy IMRT on partial vertebral body for spinal metastases

partial body group

10x3 Gy IMRT RADIATION

10x3 Gy IMRT on whole vertebral body for spinal metastases

whole body group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 23, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2019
• Last Updated: November 23, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share