Recruiting

Cryoablation & SBRT

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04693377

Conditions

Castration-Resistant Prostate Carcinoma

Metastatic Colorectal Carcinoma

Metastatic Malignant Neoplasm in the Bone

Metastatic Malignant Solid Neoplasm

Metastatic Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cryosurgery

Quality-of-Life Assessment

Stereotactic Body Radiation Therapy

Study Details

Brief summary:

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.

Conditions

Castration-Resistant Prostate Carcinoma

Metastatic Colorectal Carcinoma

Metastatic Malignant Neoplasm in the Bone

Metastatic Malignant Solid Neoplasm

Metastatic Melanoma

Study ID

NCT04693377

Start date

Mar 16, 2021

Status verified date

Apr, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Arm A (SBRT)

Patients undergo stereotactic body radiation therapy for 1 fraction.

experimental: Arm B (cryoablation, SBRT)

Patients undergo cryoablation. Within 10 days after cryoablation, patients undergo stereotactic body radiation therapy for 1 fraction. Alternatively, patients may receive stereotactic body radiation therapy initially, followed by cryoablation."

Interventions

Cryosurgery

Undergo cryoablation

Quality-of-Life Assessment

Ancillary studies

Stereotactic Body Radiation Therapy

Undergo stereotactic body radiation therapy

Primary outcome measure

  • Pain response [ Time Frame: At 12 weeks post-treatment ]

Central Contacts and Locations

Central contacts

Rahul A. Sheth, MD

713-745-0652rasheth@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Rahul A. Sheth, MD

713-745-0652

Principal Investigator:

Rahul A. Sheth, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 15, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-15.