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

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ClinicalTrials.gov Identifier: NCT04693377
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE October 13, 2020
First Posted Date  ICMJE January 5, 2021
Last Update Posted Date June 29, 2021
Actual Study Start Date  ICMJE March 16, 2021
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2020)
Pain response [ Time Frame: At 12 weeks post-treatment ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2020)
  • Daily morphine equivalent (MEDD) [ Time Frame: Baseline, assessed up to 24 weeks post-treatment ]
  • Duration of response [ Time Frame: Up to 24 weeks post-treatment ]
    Will be assessed by performing area under the curve (AUC) analysis of Brief Pain Inventory (BPI) pain scores.
  • Local control [ Time Frame: Up to 24 weeks post-treatment ]
    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.
  • Rate and severity of adverse and serious related adverse events [ Time Frame: Within 30 days of the last study treatment ]
    Point estimates and two-sided 95% confidence intervals will be generated for procedural related adverse events.
  • Technical success for cryoablation [ Time Frame: Up to 24 weeks post-treatment ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial
Official Title  ICMJE Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Procedure: Cryosurgery
    Undergo cryoablation
    Other Names:
    • Ablation, Cryo
    • Cryoablation
    • cryosurgical ablation
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
  • Radiation: Stereotactic Body Radiation Therapy
    Undergo stereotactic body radiation therapy
    Other Names:
    • SABR
    • SBRT
    • Stereotactic Ablative Body Radiation Therapy
Study Arms  ICMJE
  • Active Comparator: Arm A (SBRT)
    Patients undergo stereotactic body radiation therapy for 1 fraction.
    Interventions:
    • Other: Quality-of-Life Assessment
    • Radiation: Stereotactic Body Radiation Therapy
  • Experimental: Arm B (cryoablation, SBRT)
    Patients undergo cryoablation. Within 10 days after cryoablation, patients undergo stereotactic body radiation therapy for 1 fraction.
    Interventions:
    • Procedure: Cryosurgery
    • Other: Quality-of-Life Assessment
    • Radiation: Stereotactic Body Radiation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 30, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2023
Estimated Primary Completion Date April 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rahul A. Sheth 713-745-0652 rasheth@mdanderson.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04693377
Other Study ID Numbers  ICMJE 2019-1234
NCI-2020-07368 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-1234 ( Other Identifier: M D Anderson Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rahul A Sheth M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP