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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

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.

Condition or disease Intervention/treatment Phase
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 Procedure: Cryosurgery Other: Quality-of-Life Assessment Radiation: Stereotactic Body Radiation Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases
Actual Study Start Date : March 16, 2021
Estimated Primary Completion Date : April 1, 2023
Estimated Study Completion Date : April 1, 2023


Arm Intervention/treatment
Active Comparator: Arm A (SBRT)
Patients undergo stereotactic body radiation therapy for 1 fraction.
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

Experimental: Arm B (cryoablation, SBRT)
Patients undergo cryoablation. Within 10 days after cryoablation, patients undergo stereotactic body radiation therapy for 1 fraction.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Daily morphine equivalent (MEDD) [ Time Frame: Baseline, assessed up to 24 weeks post-treatment ]
  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693377


Contacts
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Contact: Rahul A. Sheth 713-745-0652 rasheth@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Rahul A. Sheth    713-745-0652      
Principal Investigator: Rahul A. Sheth         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Rahul A Sheth M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04693377    
Other Study ID Numbers: 2019-1234
NCI-2020-07368 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2019-1234 ( Other Identifier: M D Anderson Cancer Center )
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021

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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
Additional relevant MeSH terms:
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Carcinoma
Prostatic Neoplasms
Neoplasms
Colorectal Neoplasms
Carcinoma, Renal Cell
Thyroid Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Kidney Diseases
Urologic Diseases
Endocrine Gland Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases