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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04693377
Status
Recruiting
Apply to this 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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cryosurgery — PROCEDURE
    Undergo cryoablation
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Stereotactic Body Radiation Therapy — RADIATION
    Undergo stereotactic body radiation therapy

Study Details

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.

Key Dates

Start date
Mar 16, 2021
Status verified
Apr 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

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."

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Rahul A. Sheth, MD
713-745-0652
Rahul A. Sheth, MD (PRINCIPAL_INVESTIGATOR)

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