Advanced Malignant NeoplasmNCT04119037
Cordotomy in Reducing Pain in Patients With Advanced Cancer
A study testing Cordotomy, Morphine and Questionnaire Administration in people with Advanced Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well cordotomy works in reducing pain in patients with cancer that has spread to other places in the body (advanced). Cordotomy is performed on the spinal cord with a needle and guided by computed tomography scans and is designed to help reduce pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Neoplasm
- What is being tested?
- Cordotomy, Morphine and Questionnaire Administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2019to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent
- Has undergone 3 palliative care evaluations
- Pain intensity >= 4 on a 0-10 numerical scale
- Unilateral pain due to cancer below the shoulder level (arm, trunk, hip, leg)
Who cannot join
- Uncorrectable coagulopathy
- Large intracranial mass
- Inability to complete assessment forms
- Life expectancy < 1 month
- Contraindication to intravenous sedation
- Morphine allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Cordotomy for Pain Palliation in Advanced Cancer
This trial studies how well cordotomy works in reducing pain in patients with cancer that has spread to other places in the body (advanced). Cordotomy is performed on the spinal cord with a needle and guided by computed tomography scans and is designed to help reduce pain. This study is being done to learn if a cordotomy reduces pain in patients with unmanageable cancer pain.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess the efficacy of cordotomy for patients with unilateral advanced cancer pain.
SECONDARY OBJECTIVES:
- Define the patient experience of cordotomy for cancer pain refractory to palliative care.
II. Determine whether magnetic resonance imaging (MRI) can be used as a noninvasive biomarker for a successful cordotomy.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo a cordotomy over 1-2 hours.
GROUP II: Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.
After completion of study, patients are followed up at 2 weeks and once every month for up to 6 months.
- Conditions
- Advanced Malignant Neoplasm
- Being tested
- Cordotomy, Morphine, Questionnaire Administration, Sham Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CordotomyProcedure or surgery
Undergo cordotomy
MorphineDrug
Given via injection
Questionnaire AdministrationOther
Ancillary studies
Sham InterventionProcedure or surgery
Undergo fake cordotomy
| Study group | Role | What they receive |
|---|---|---|
| Group I (cordotomy) | Experimental | Patients undergo a cordotomy over 1-2 hours. Receives: Procedure: Cordotomy; Other: Questionnaire Administration |
| Group II (morphine, fake cordotomy) | Sham comparator | Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours. Receives: Drug: Morphine; Other: Questionnaire Administration; Procedure: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain intensity
Will be measured by the Edmonton Symptom Assessment Scale (ESAS).
Measured: Up to 6 months
Secondary outcomes (2)
Brief Pain Inventory pain interference items
Will provide initial estimates of the magnitude of the effect of cordotomy.
Measured: Up to 6 months
Other ESAS symptoms
Will provide initial estimates of the magnitude of the effect of cordotomy.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start16 Sep 2019
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Eduardo Bruera, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119037
- Sponsor's protocol ID
- 2019-0264
- Other IDs
- NCI-2019-03708, 2019-0264, R01NR018481
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2019
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Cordotomy for Pain Palliation in Advanced Cancer
- ClinicalTrials.gov ID
- NCT04119037
- Acronym / sponsor ID
- 2019-0264
- Conditions
- Advanced Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute of Nursing Research (NINR)
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 8 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies how well cordotomy works in reducing pain in patients with cancer that has spread to other places in the body (advanced). Cordotomy is performed on the spinal cord with a needle and guided by computed tomography scans and is designed to help reduce pain. This study is being done to learn if a cordotomy reduces pain in patients with unmanageable cancer pain.
Detailed description
PRIMARY OBJECTIVES:
- Assess the efficacy of cordotomy for patients with unilateral advanced cancer pain.
SECONDARY OBJECTIVES:
- Define the patient experience of cordotomy for cancer pain refractory to palliative care.
II. Determine whether magnetic resonance imaging (MRI) can be used as a noninvasive biomarker for a successful cordotomy.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo a cordotomy over 1-2 hours.
GROUP II: Patients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours.
After completion of study, patients are followed up at 2 weeks and once every month for up to 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (cordotomy) | Experimental | Procedure: Cordotomy, Other: Questionnaire AdministrationPatients undergo a cordotomy over 1-2 hours. |
| Group II (morphine, fake cordotomy) | Sham comparator | Drug: Morphine, Other: Questionnaire Administration, Procedure: Sham InterventionPatients receive morphine via injection into the spine and undergo a fake cordotomy over 1-2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to provide informed consent
- Has undergone 3 palliative care evaluations
- Pain intensity >= 4 on a 0-10 numerical scale
- Unilateral pain due to cancer below the shoulder level (arm, trunk, hip, leg)
Key exclusion criteria (6 listed)
- Uncorrectable coagulopathy
- Large intracranial mass
- Inability to complete assessment forms
- Life expectancy < 1 month
- Contraindication to intravenous sedation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CordotomyUndergo cordotomy | Procedure or surgery | Group I (cordotomy) |
| MorphineGiven via injection | Drug | Group II (morphine, fake cordotomy) |
| Questionnaire AdministrationAncillary studies | Other | Group I (cordotomy), Group II (morphine, fake cordotomy) |
| Sham InterventionUndergo fake cordotomy | Procedure or surgery | Group II (morphine, fake cordotomy) |
Primary outcome
Reduction in pain intensity
Time frame: Up to 6 months
Will be measured by the Edmonton Symptom Assessment Scale (ESAS).
2 secondary outcomes
Brief Pain Inventory pain interference items
Time frame: Up to 6 months
Other ESAS symptoms
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Advanced Malignant Neoplasm
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Phase 1/2 Study of DS010 in Advanced Cancer Patients With Cachexia
Cancer, Cachexia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Bruera principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cordotomy, Morphine and Questionnaire Administration in people with Advanced Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain intensity (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.