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NCT04693377 · ClinicalTrials.gov registry record · NA
Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial
A NA study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04693377: Recruiting NA study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma, sponsored by M.D. Anderson Cancer Center.
NCT04693377 is a NA study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 40 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04693377, a NA study of Metastatic Malignant Solid Neoplasm and Metastatic Melanoma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- RADIATION Stereotactic Body Radiation Therapy
- PROCEDURE Cryosurgery
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-03-16 |
| Est. Completion | 2027-04-01 |
| Phase | NA |
What NCT04693377 shows while recruiting
NCT04693377 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (81% lower).
The record links to 10 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 3 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04693377 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04693377 about?
NCT04693377 is a clinical study titled "Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME 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,...
What is the current status of trial NCT04693377?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2021-03-16. Estimated completion is 2027-04-01.
What conditions does trial NCT04693377 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Metastatic Melanoma, Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Metastatic Renal Cell Carcinoma.
What interventions are being tested in trial NCT04693377?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Stereotactic Body Radiation Therapy (RADIATION), Cryosurgery (PROCEDURE).
Who is sponsoring clinical trial NCT04693377?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04693377 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04693377's enrollment target sits among peer trials
40 63rd of 92 higher than 25 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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