Clinical Trials /

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

NCT04693377

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.

Related Conditions:
  • Colorectal Carcinoma
  • Melanoma
  • Prostate Carcinoma
  • Renal Cell Carcinoma
  • Sarcoma
  • Thyroid Gland Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial
  • Official Title: Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases

Clinical Trial IDs

  • ORG STUDY ID: 2019-1234
  • SECONDARY ID: NCI-2020-07368
  • SECONDARY ID: 2019-1234
  • NCT ID: NCT04693377

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

Purpose

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.

Detailed Description

      PRIMARY OBJECTIVE:

      I. To determine the efficacy of cryoablation in combination with stereotactic body radiation
      therapy (SBRT) or SBRT only for the treatment of painful bone metastases.

      SECONDARY OBJECTIVES:

      I. To assess for narcotics utilization by daily morphine equivalent dose. II. To assess
      duration of pain response reported by International Pain Response Criteria.

      III. To assess for local tumor control. IV. To assess for changes in patient quality of life
      with Brief Pain Inventory (BPI) score.

      V. To assess for adverse event rates. VI. To assess incidence and severity of adverse
      events/toxicity. VII. To assess technical success for cryoablation.

      EXPLORATORY OBJECTIVE:

      I. To investigate the local microenvironmental changes following SBRT and cryoablation
      combined with SBRT to bone metastases.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM A: Patients undergo stereotactic body radiation therapy for 1 fraction.

      ARM B: Patients undergo cryoablation. Within 10 days after cryoablation, patients undergo
      stereotactic body radiation therapy for 1 fraction.

      After completion of study treatment, patients are followed up at 1, 2, 3, 4, 8, 12, 16, 20,
      and 24 weeks.
    

Trial Arms

NameTypeDescriptionInterventions
Arm A (SBRT)Active ComparatorPatients undergo stereotactic body radiation therapy for 1 fraction.
    Arm B (cryoablation, SBRT)ExperimentalPatients undergo cryoablation. Within 10 days after cryoablation, patients undergo stereotactic body radiation therapy for 1 fraction.

      Eligibility Criteria

              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
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Pain response
      Time Frame:At 12 weeks post-treatment
      Safety Issue:
      Description:Defined as complete or partial response as reported by the International Pain Response Criteria at the site of the treated bone metastasis based on the BPI pain score and daily morphine equivalent (MEDD). Will be summarized separately for each treatment arm with associated 95% exact confidence intervals.

      Secondary Outcome Measures

      Measure:Daily morphine equivalent (MEDD)
      Time Frame:Baseline, assessed up to 24 weeks post-treatment
      Safety Issue:
      Description:
      Measure:Duration of response
      Time Frame:Up to 24 weeks post-treatment
      Safety Issue:
      Description:Will be assessed by performing area under the curve (AUC) analysis of Brief Pain Inventory (BPI) pain scores.
      Measure:Local control
      Time Frame:Up to 24 weeks post-treatment
      Safety Issue:
      Description:Will be determined by imaging evidence of residual viable tumor. Standard of care cross-sectional imaging and bone scintigraphy will be performed at 3 month intervals.
      Measure:Rate and severity of adverse and serious related adverse events
      Time Frame:Within 30 days of the last study treatment
      Safety Issue:
      Description:Point estimates and two-sided 95% confidence intervals will be generated for procedural related adverse events.
      Measure:Technical success for cryoablation
      Time Frame:Up to 24 weeks post-treatment
      Safety Issue:
      Description:Will be determined by identifying on intra-procedural imaging when the leading edge of the ice successfully extends beyond the tumor margin by at least 5 mm.

      Details

      Phase:N/A
      Primary Purpose:Interventional
      Overall Status:Not yet recruiting
      Lead Sponsor:M.D. Anderson Cancer Center

      Last Updated

      February 15, 2021