Health TrialsbyHealthPanel

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

ConditionsCastration-Resistant Prostate CarcinomaMetastatic Colorectal CarcinomaMetastatic Malignant Neoplasm in the BoneMetastatic Malignant Solid NeoplasmMetastatic MelanomaMetastatic Prostate CarcinomaMetastatic Renal Cell CarcinomaMetastatic SarcomaMetastatic Thyroid Gland CarcinomaMetastatic Urothelial CarcinomaStage IV Colorectal Cancer AJCC v8Stage IV Prostate Cancer AJCC v8Stage IV Renal Cell Cancer AJCC v8Stage IVA Colorectal Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8Stage IVB Colorectal Cancer AJCC v8Stage IVB Prostate Cancer AJCC v8Stage IVC Colorectal Cancer AJCC v8
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cryosurgery

    Procedure/Surgery

    Undergo cryoablation

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Stereotactic Body Radiation Therapy

    Radiation

    Undergo stereotactic body radiation therapy

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Arm A (SBRT)Active comparator 2 interventions
Group B: Arm B (cryoablation, SBRT)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pain response

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.

Time frame
At 12 weeks post-treatment

Secondary outcomes

1

Daily morphine equivalent (MEDD)

Time frame
Baseline, assessed up to 24 weeks post-treatment
2

Duration of response

Will be assessed by performing area under the curve (AUC) analysis of Brief Pain Inventory (BPI) pain scores.

Time frame
Up to 24 weeks post-treatment
3

Local control

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.

Time frame
Up to 24 weeks post-treatment
4

Rate and severity of adverse and serious related adverse events

Point estimates and two-sided 95% confidence intervals will be generated for procedural related adverse events.

Time frame
Within 30 days of the last study treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov
Apply now