RECRUITING

Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial

Conditions

Castration-Resistant Prostate Carcinoma Metastatic Colorectal Carcinoma Metastatic Malignant Neoplasm in the Bone Metastatic Malignant Solid Neoplasm Metastatic Melanoma Metastatic Prostate Carcinoma Metastatic Renal Cell Carcinoma Metastatic Sarcoma Metastatic Thyroid Gland Carcinoma Metastatic Urothelial Carcinoma Stage IV Colorectal Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IV Renal Cell Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This trial compares cryoablation combined with stereotactic body radiation therapy to stereotactic body radiation therapy alone to see how well they work in treating patients with pain from cancer that has spread to the bones (bone metastases). Bone is a common site of metastasis in advanced cancer, and bone metastases often result in debilitating cancer-related pain. The current standard of care to treat painful bone metastases is radiation therapy alone. However, many patients do not get adequate pain relief from radiation therapy alone. Another type of therapy that may be used to provide pain relief from bone metastases is cryoablation. Cryoablation is a procedure in which special needles are inserted into the tumor site. These needles grow ice balls at their tips to freeze and kill cancer cells. The goal of this trial is to compare how well cryoablation in combination with radiation therapy works to radiation therapy alone when given to cancer patients to provide pain relief from bone metastases.

Official Title

Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases

Quick Facts

Study Start:2021-03-16

Study Completion:2027-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04693377

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patient must have a primary diagnosis of malignancy and radiographic evidence of bone metastases. Eligible tumor histologies include the following malignancies with low alpha/beta ratios: renal cell carcinoma, urothelial carcinomas, castration-resistant prostate cancer, sarcoma, thyroid carcinoma, colorectal carcinoma, and melanoma * A target lesion the meets the following criteria: * The target lesion must be amenable to both cryoablation and SBRT, as determined by the study principal investigators (PIs) * The target lesion must be =\< 7cm * The pain due to the target lesion must be at least 4/10 based on the BPI pain scale * Pain from the metastatic site must correlate with an identifiable tumor on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) imaging * Life expectancy \>= 3 months * Platelet count \> 50,000/mm\^3 within 6 weeks of screening * International normalized ratio (INR) \< 1.5 within 6 weeks of screening * If taking antiplatelet or anticoagulation medication, it must be able to be discontinued 48 hours prior to the procedure or at the discretion of the PI (e.g., aspirin, ibuprofen, low molecular weight heparin \[LMWH\] preparations) * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) within 6 weeks of screening * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization. Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization * All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible * Ability to understand and the willingness to sign a written informed consent document	* Prior locoregional therapy to target lesion, including ablation of any modality, embolization, radiation, or surgery * Patient may not be receiving any other investigational agents. Standard concurrent chemotherapy, immunotherapy, or targeted therapy will be allowed * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator * Target lesions that involve the spinal column or calvarium * Absolute neutrophil count \< 1000 mm\^3 within 6 weeks of screening * Active infection * Presence of confirmed pathologic fracture at the target lesion not amenable to percutaneous stabilization * Lesions that involve a weight-bearing long bone of the lower extremity with the tumor causing \> 50% loss of cortical bone. Lesions involving the hands and feet

Inclusion Criteria

Exclusion Criteria

* Patient must have a primary diagnosis of malignancy and radiographic evidence of bone metastases. Eligible tumor histologies include the following malignancies with low alpha/beta ratios: renal cell carcinoma, urothelial carcinomas, castration-resistant prostate cancer, sarcoma, thyroid carcinoma, colorectal carcinoma, and melanoma
* A target lesion the meets the following criteria:
* The target lesion must be amenable to both cryoablation and SBRT, as determined by the study principal investigators (PIs)
* The target lesion must be =\< 7cm
* The pain due to the target lesion must be at least 4/10 based on the BPI pain scale
* Pain from the metastatic site must correlate with an identifiable tumor on computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound (US) imaging
* Life expectancy \>= 3 months
* Platelet count \> 50,000/mm\^3 within 6 weeks of screening
* International normalized ratio (INR) \< 1.5 within 6 weeks of screening
* If taking antiplatelet or anticoagulation medication, it must be able to be discontinued 48 hours prior to the procedure or at the discretion of the PI (e.g., aspirin, ibuprofen, low molecular weight heparin \[LMWH\] preparations)
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) within 6 weeks of screening
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization. Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization
* All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible
* Ability to understand and the willingness to sign a written informed consent document

* Prior locoregional therapy to target lesion, including ablation of any modality, embolization, radiation, or surgery
* Patient may not be receiving any other investigational agents. Standard concurrent chemotherapy, immunotherapy, or targeted therapy will be allowed
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, interstitial lung disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant or nursing women; women of childbearing potential unless using effective contraception as determined by the investigator
* Target lesions that involve the spinal column or calvarium
* Absolute neutrophil count \< 1000 mm\^3 within 6 weeks of screening
* Active infection
* Presence of confirmed pathologic fracture at the target lesion not amenable to percutaneous stabilization
* Lesions that involve a weight-bearing long bone of the lower extremity with the tumor causing \> 50% loss of cortical bone. Lesions involving the hands and feet

Contacts and Locations

Study Contact

Rahul A. Sheth, MD

CONTACT

713-745-0652

rasheth@mdanderson.org

Principal Investigator

Rahul A Sheth, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Rahul A Sheth, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-16

Study Completion Date2027-04-01

Study Record Updates

Study Start Date2021-03-16

Study Completion Date2027-04-01

Terms related to this study

Additional Relevant MeSH Terms

Castration-Resistant Prostate Carcinoma
Metastatic Colorectal Carcinoma
Metastatic Malignant Neoplasm in the Bone
Metastatic Malignant Solid Neoplasm
Metastatic Melanoma
Metastatic Prostate Carcinoma
Metastatic Renal Cell Carcinoma
Metastatic Sarcoma
Metastatic Thyroid Gland Carcinoma
Metastatic Urothelial Carcinoma
Stage IV Colorectal Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8
Stage IV Renal Cell Cancer AJCC v8
Stage IVA Colorectal Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Stage IVB Prostate Cancer AJCC v8
Stage IVC Colorectal Cancer AJCC v8