Part A: Effect of Prophylactic Vertebroplasty Combined With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)

New trial tests vertebroplasty with radiation for spine cancer spread

NCT: NCT05178472 · Status: RECRUITING · Phase: N/A · Sponsor: Ohio State University Comprehensive Cancer Center · Started: 2023-03-27 · Est. Completion: 2026-12-31

Plain English Summary

Vertebroplasty With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria) is a Not Applicable clinical trial sponsored by Ohio State University Comprehensive Cancer Center studying Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Spine. This trial tests if adding a procedure called vertebroplasty to radiation therapy helps patients with cancer that has spread to the spine. It is for adults with cancer that has spread to the spine and is considered resistant to radiation. Participants will receive standard radiation therapy, and some may also receive vertebroplasty (a procedure to repair a bone) and/or immunotherapy. Alternative treatments may include surgery, radiation alone, or other cancer therapies depending on the patient's specific situation. The trial aims to enroll 200 participants.

Official Summary

This clinical trial studies the side effects of stereotactic radiosurgery and how well it works with or without vertebroplasty, separation surgery, or immunotherapy in patients with cancer that is radiation resistant and has spread to the spine (spinal metastases). Spinal metastases are rapidly progressive, have poor prognosis, are extremely difficult to treat, and can effect patient quality of life and overall health. Immunotherapy is a type of standard of care therapy to boost or restore the ability of the immune system to fight cancer. Stereotactic radiosurgery is a type of external radiation therapy that uses special equipment to position the patient and precisely give a single large dose of radiation to a tumor. A vertebroplasty is a procedure used to repair a bone in the spine that has a break caused by cancer, osteoporosis, or trauma. The purpose of this trial is to test different combinations of immunotherapy, stereotactic radiosurgery, and surgery to improve overall survival and quality of life in patients with spinal metastases.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with cancer that has spread to the spine. Patients whose cancer requires radiation therapy as part of their treatment. Individuals with a limited number of spinal segments affected by the tumor. Patients must be able to complete quality of life questionnaires in English or Spanish. This trial is studying Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Spine, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The trial will measure how often patients experience vertebral compression fractures and how well the cancer is controlled locally at 6 months, aiming to reduce bone damage and stop cancer growth in t The specific primary outcome measures are: Vertebral compression fracture (VCF) rate (At 6 months); Local control (At 6 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial addresses a critical need for better treatments for spinal metastases, which are difficult to manage and significantly impact patient quality of life. This research targets Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Spine, where improved treatment options are needed.

Investor Insight

This trial focuses on a challenging area of oncology, potentially improving outcomes for patients with spinal metastases, a significant unmet need.

Is This Trial Right for Me?

Ask your doctor if this trial is a good fit for your specific cancer and overall health. Understand that participation involves receiving radiation therapy, and potentially a procedure called vertebroplasty and/or immunotherapy. You will need to attend regular appointments for treatment and monitoring, and complete quality of life questionnaires. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

* At least 18 years of age and older with indeterminate Spine Metastasis.
* All patients with histology that requires stereotactic RT as a part of their treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Disease visualized by CT or MRI
* Prior radiation therapy will be allowed at the discretion of the Radiation Oncologist based on current standard operating procedures.
* Tumor tissue from the core biopsy or resected site of disease will be collected, if available for biomarker analyses.
* Four or less consecutive spinal segments involved by tumor. Or four or less separate spinal tumor targets with a minimum of one vertebral body separation
* Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaire in either English or Spanish. The baseline assessment must be completed within required timelines. Inability (illiteracy in English or Spanish, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible

Exclusion Criteria:

* Patients \< 18 years of age
* Inability to get a standard MRI or CT myelogram for radiation treatment target delineation
* Patients with prior radiation to the spinal segment to be treated may be included if the radiation dose can be delivered safely, per the treating radiation oncologist.
* Patients with symptomatic spinal cord compression requiring emergent surgery
* Pregnant or lactating women
* Systemic therapy or immunosuppressive medications, excluding immunotherapy, within 3-14 days of radiation treatment, at the discretion of the treating radiation oncologist .
* Patients with stable or unstable lesions based on SINS criteria

Trial Locations

Frequently Asked Questions

What is clinical trial NCT05178472?

NCT05178472 is a Not Applicable INTERVENTIONAL study titled "Vertebroplasty With Radiation Therapy for Spine Metastatic Cancer Patients With Indeterminate Lesion (SINS Criteria)." It is currently recruiting and is sponsored by Ohio State University Comprehensive Cancer Center. The trial targets enrollment of 200 participants.

What conditions does NCT05178472 study?

This trial investigates treatments for Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Spine. The primary condition under study is Hematopoietic and Lymphoid Cell Neoplasm.

What treatments are being tested in NCT05178472?

The interventions being studied include: Immunotherapy (OTHER), Stereotactic Radiosurgery (RADIATION), Vertebroplasty (PROCEDURE). Receive SOC immunotherapy

What does Not Applicable mean for NCT05178472?

This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.

What is the current status of NCT05178472?

This trial is currently "Recruiting." It started on 2023-03-27. The estimated completion date is 2026-12-31.

Who is sponsoring NCT05178472?

NCT05178472 is sponsored by Ohio State University Comprehensive Cancer Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05178472?

The trial aims to enroll 200 participants. The trial is currently recruiting and accepting new participants.

How is NCT05178472 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT05178472?

The primary outcome measures are: Vertebral compression fracture (VCF) rate (At 6 months); Local control (At 6 months). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05178472 being conducted?

This trial is being conducted at 1 site, including Columbus, Ohio (United States).

Where can I find official information about NCT05178472?

The official record for NCT05178472 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05178472. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05178472 testing in simple terms?

This trial tests if adding a procedure called vertebroplasty to radiation therapy helps patients with cancer that has spread to the spine. It is for adults with cancer that has spread to the spine and is considered resistant to radiation.

Why is this trial significant?

This trial addresses a critical need for better treatments for spinal metastases, which are difficult to manage and significantly impact patient quality of life.

What are the potential risks of participating in NCT05178472?

Potential side effects of radiation therapy include fatigue, skin irritation, and pain. Vertebroplasty carries risks such as infection, bleeding, or leakage of the bone cement. Immunotherapy can cause immune system reactions, leading to inflammation in various organs. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05178472?

Ask your doctor if this trial is a good fit for your specific cancer and overall health. Understand that participation involves receiving radiation therapy, and potentially a procedure called vertebroplasty and/or immunotherapy. You will need to attend regular appointments for treatment and monitoring, and complete quality of life questionnaires. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05178472 signal from an investment perspective?

This trial focuses on a challenging area of oncology, potentially improving outcomes for patients with spinal metastases, a significant unmet need. This is a Not Applicable trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will receive standard radiation therapy, and some may also receive vertebroplasty (a procedure to repair a bone) and/or immunotherapy. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

Related Conditions

More Hematopoietic and Lymphoid Cell Neoplasm Trials

View all Hematopoietic and Lymphoid Cell Neoplasm clinical trials

This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.