Cement Augmentation for Cancer with Spinal Metastases

Recruiting in Palo Alto (17 mi)

Amol J. Ghia | MD Anderson Cancer Center

Overseen byAmol J. Ghia

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?This randomized phase II trial studies how well cement augmentation works in preventing vertebral body compression fracture following spine stereotactic radiosurgery in patients with solid tumors that have spread to the spine. Spine stereotactic radiosurgery delivers a high dose of radiation to vertebral metastases and can sometimes lead to a vertebral compression fracture. Using body cement on the largest part of the vertebra (a procedure called vertebral body cement augmentation) may help prevent a fracture after stereotactic spinal radiosurgery. It may also lessen pain and improve quality of life in patients with solid tumors and spinal metastases undergoing this surgery.

Eligibility Criteria

This trial is for adults with solid tumors that have spread to the spine, can lie flat, and are at high risk of spinal fractures post-radiosurgery. They should be relatively active (able to care for themselves), expected to live more than 3 months, and agree to use contraception. Those who've had prior spine surgery or radiotherapy at the same spot, severe vertebral damage, or certain cancers like lymphoma aren't eligible.

Inclusion Criteria

I have a confirmed solid tumor cancer that has spread to my spine.

All patients must be deemed at "high risk" of developing vertebral body fracture by having at least one of the following characteristics: Spine Instability Neoplastic Score classification of "Indeterminate" deemed as a score from 7 to 12, Pre-existing vertebral body fracture, Planned radiation dose of 24 Gy, All patients must have a vertebral body site to be treated located from T1 to L5, Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately, All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of M.D. Anderson Cancer Center; the only acceptable consent is the one approved by M.D. Anderson Institutional Review Board (IRB), Patients undergoing bisphosphonate therapy are allowed

I have received a specific radiation dose to my spine.

+4 more

Exclusion Criteria

I have had surgery on my spine before, such as for tumor removal or bone support.

I experience clear, mechanical pain.

My spine condition involves significant disease affecting both sides at a specific level.

+8 more

Participant Groups

The study tests if injecting cement into vertebrae after high-dose radiation therapy (spine stereotactic radiosurgery) prevents fractures in patients with cancerous spine tumors. It's a phase II trial comparing patients receiving cement augmentation against those who don't, assessing pain relief and life quality.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (vertebral body cement augmentation)Experimental Treatment4 Interventions

Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.

Group II: Arm I (standard of care)Active Control3 Interventions

Patients undergo stereotactic spinal radiosurgery per standard of care.

Stereotactic Radiosurgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Stereotactic Radiosurgery for: