Cancer PainNCT07871123
Radiosurgery for Severe Refractory Cancer Pain: A Sham-Controlled Pilot Trial
A study testing Triple-target stereotactic radiosurgery in people with Cancer Pain and Refractory Pain, run by Centro Internacional del Cáncer at 1 site in El Salvador.
Trial summary
This pilot randomized trial assessed whether a sham-controlled comparison of triple-target stereotactic radiosurgery is feasible in adults with advanced (stage IV) cancer and severe mixed pain refractory to optimized pharmacologic and specialist management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Refractory Pain
- What is being tested?
- Triple-target stereotactic radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteEl Salvador
- Study dates
- 1 Apr 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults aged 18 years or older
- Documented diagnosis of Stage IV cancer
- Severe mixed pain with somatic, visceral, and/or neuropathic components
- Refractory pain according to Deer et al., as determined by the attending palliative care physician
- Pain score ≥6 on a 0-10 visual analog scale on at least two assessments performed on different days
- Receiving palliative care, with estimated survival >30 days and >50% probability of survival at 29-30 days according to the Palliative Performance Scale
Who cannot join
- Prior surgery or radiation involving the pituitary gland or thalamus
- Inability to report pain using the visual analog scale
- Pregnancy
Trial locations and contacts
1 site in 1 country.
El Salvador1 site
Centro Internacional de Cáncer
San Salvador, San Salvador Department
About this study
Official title: Triple-Target Stereotactic Radiosurgery for Refractory Mixed Cancer Pain: A Sham-Controlled Pilot Randomized Controlled Trial
This pilot randomized trial assessed whether a sham-controlled comparison of triple-target stereotactic radiosurgery is feasible in adults with advanced (stage IV) cancer and severe mixed pain refractory to optimized pharmacologic and specialist management. Participants were randomized 1:1 to single-session Gamma Knife radiosurgery delivered to the hypophysis and both medial thalami, or to an identical sham procedure without radiation; both arms continued standard pain care. The main comparison was the change in pain intensity on a 0-10 visual analog scale from baseline to day 15. Opioid consumption, quality of life, and safety were explored. Enrollment was stopped after 10 of a planned 20 participants following an ethical reassessment by the investigators.
- Conditions
- Cancer Pain, Refractory Pain
- Being tested
- Triple-target stereotactic radiosurgery, Sham radiosurgery
- Keywords
- cancer pain, refractory pain, stereotactic radiosurgery, Gamma Knife, medial thalamotomy, hypophysis, palliative care, sham-controlled trial
- Medical subject headings
- Cancer Pain, Pain, Intractable, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple-target stereotactic radiosurgeryRadiation
Single-session Gamma Knife radiosurgery to the hypophysis and bilateral medial thalamus, 45 Gy prescribed at the 50% isodose line (maximum 90 Gy), plus standard pain care.
Sham radiosurgeryProcedure or surgery
Identical preoperative evaluation, imaging, sedation, stereotactic frame placement and ~40-minute waiting period, with no treatment plan and no radiation delivered, plus standard pain care.
| Study group | Role | What they receive |
|---|---|---|
| Triple-target stereotactic radiosurgery | Experimental | Single-session Gamma Knife radiosurgery to the hypophysis and bilateral medial thalamus, 45 Gy prescribed at the 50% isodose line (maximum 90 Gy), plus standard pain care. Receives: Radiation: Triple-target stereotactic radiosurgery |
| Sham radiosurgery | Sham comparator | Identical preoperative evaluation, imaging, sedation, stereotactic frame placement and ~40-minute waiting period, with no treatment plan and no radiation delivered, plus standard pain care. Receives: Procedure: Sham radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity on a 0-10 Visual Analog Scale (VAS)
Pain measured on a 0-10 VAS (0 = no pain, 10 = worst imaginable pain). Mean change from baseline to day 15, the latest scheduled assessment with complete data in all participants. Negative values indicate pain reduction.
Measured: Baseline and 15 days
Secondary outcomes (2)
Change in Daily Opioid Consumption (Morphine Milligram Equivalents)
Daily opioid requirement converted to mg MME/day. Mean change from baseline to each participant's final follow-up.
Measured: Baseline up to 12 months
Number of Participants With Serious Adverse Events, Adverse Radiation Effects, or Hypopituitarism
Safety monitored at every contact, with endocrine profiles before the procedure and monthly thereafter.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Apr 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Why it stopped: Enrollment halted after 10 of 20 planned participants following ethical reassessment by the investigators; continued sham allocation was judged ethically disproportionate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Internacional del Cáncer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871123
- Sponsor's protocol ID
- CNEIS/2022/10
- Other IDs
- CNEIS/2022/10
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant-level data, the data dictionary, the study protocol, and the analysis code are available from the corresponding author on reasonable request.
Publications
Lovo EE, Moreira A, Cruz C, Carvajal G, Barahona KC, Caceros V, Blanco A, Mejias R, Alho E, Soto T. Radiomodulation in Mixed, Complex Cancer Pain by Triple Target Irradiation in the Brain: A Preliminary Experience. Cureus. 2022 May 28;14(5):e25430. doi: 10.7759/cureus.25430. eCollection 2022 May.
PubMed 35774662Lovo EE, Campos FJ, Caceros VE, Minervini M, Cruz CB, Arias JC, Reyes WA. Automated Stereotactic Gamma Ray Radiosurgery to the Pituitary Gland in Terminally Ill Cancer Patients with Opioid Refractory Pain. Cureus. 2019 Jun 3;11(6):e4811. doi: 10.7759/cureus.4811.
PubMed 31403008
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple-Target Stereotactic Radiosurgery for Refractory Mixed Cancer Pain: A Sham-Controlled Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07871123
- Acronym / sponsor ID
- CNEIS/2022/10
- Conditions
- Cancer Pain, Refractory Pain
- Keywords
- cancer pain, refractory pain, stereotactic radiosurgery, Gamma Knife, medial thalamotomy, hypophysis, palliative care, sham-controlled trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment halted after 10 of 20 planned participants following ethical reassessment by the investigators; continued sham allocation was judged ethically disproportionate.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centro Internacional del CáncerUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 13 Oct 2026 (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 pilot randomized trial assessed whether a sham-controlled comparison of triple-target stereotactic radiosurgery is feasible in adults with advanced (stage IV) cancer and severe mixed pain refractory to optimized pharmacologic and specialist management. Participants were randomized 1:1 to single-session Gamma Knife radiosurgery delivered to the hypophysis and both medial thalami, or to an identical sham procedure without radiation; both arms continued standard pain care. The main comparison was the change in pain intensity on a 0-10 visual analog scale from baseline to day 15. Opioid consumption, quality of life, and safety were explored. Enrollment was stopped after 10 of a planned 20 participants following an ethical reassessment by the investigators.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple-target stereotactic radiosurgery | Experimental | Radiation: Triple-target stereotactic radiosurgerySingle-session Gamma Knife radiosurgery to the hypophysis and bilateral medial thalamus, 45 Gy prescribed at the 50% isodose line (maximum 90 Gy), plus standard pain care. |
| Sham radiosurgery | Sham comparator | Procedure: Sham radiosurgeryIdentical preoperative evaluation, imaging, sedation, stereotactic frame placement and ~40-minute waiting period, with no treatment plan and no radiation delivered, plus standard pain care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older
- Documented diagnosis of Stage IV cancer
- Severe mixed pain with somatic, visceral, and/or neuropathic components
- Refractory pain according to Deer et al., as determined by the attending palliative care physician
- Pain score ≥6 on a 0-10 visual analog scale on at least two assessments performed on different days
Key exclusion criteria (3 listed)
- Prior surgery or radiation involving the pituitary gland or thalamus
- Inability to report pain using the visual analog scale
- Pregnancy
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 |
|---|---|---|
| Triple-target stereotactic radiosurgerySingle-session Gamma Knife radiosurgery to the hypophysis and bilateral medial thalamus, 45 Gy prescribed at the 50% isodose line (maximum 90 Gy), plus standard pain care. | Radiation | Triple-target stereotactic radiosurgery |
| Sham radiosurgeryIdentical preoperative evaluation, imaging, sedation, stereotactic frame placement and ~40-minute waiting period, with no treatment plan and no radiation delivered, plus standard pain care. | Procedure or surgery | Sham radiosurgery |
Primary outcome
Change in Pain Intensity on a 0-10 Visual Analog Scale (VAS)
Time frame: Baseline and 15 days
Pain measured on a 0-10 VAS (0 = no pain, 10 = worst imaginable pain). Mean change from baseline to day 15, the latest scheduled assessment with complete data in all participants. Negative values indicate pain reduction.
2 secondary outcomes
Change in Daily Opioid Consumption (Morphine Milligram Equivalents)
Time frame: Baseline up to 12 months
Number of Participants With Serious Adverse Events, Adverse Radiation Effects, or Hypopituitarism
Time frame: Up to 12 months
Results and safety
The study was stopped early (reason given: Enrollment halted after 10 of 20 planned participants following ethical reassessment by the investigators; continued sham allocation was judged ethically disproportionate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 35774662Lovo EE, Moreira A, Cruz C, Carvajal G, Barahona KC, Caceros V, Blanco A, Mejias R, Alho E, Soto T. Radiomodulation in Mixed, Complex Cancer Pain by Triple Target Irradiation in the Brain: A Preliminary Experience. Cureus. 2022 May 28;14(5):e25430. doi: 10.7759/cureus.25430. eCollection 2022 May.
- Background: PubMed 31403008Lovo EE, Campos FJ, Caceros VE, Minervini M, Cruz CB, Arias JC, Reyes WA. Automated Stereotactic Gamma Ray Radiosurgery to the Pituitary Gland in Terminally Ill Cancer Patients with Opioid Refractory Pain. Cureus. 2019 Jun 3;11(6):e4811. doi: 10.7759/cureus.4811.
- Individual participant dataSharing planned: Yes. De-identified participant-level data, the data dictionary, the study protocol, and the analysis code are available from the corresponding author on reasonable request.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple-target stereotactic radiosurgery in people with Cancer Pain and Refractory Pain, run by Centro Internacional del Cáncer at 1 site in El Salvador.
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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 13 Oct 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 El Salvador. 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?
The study was stopped early (reason given: Enrollment halted after 10 of 20 planned participants following ethical reassessment by the investigators; continued sham allocation was judged ethically disproportionate.). Results are not available in the source record.
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?
Change in Pain Intensity on a 0-10 Visual Analog Scale (VAS) (time frame: Baseline and 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07871123, which also lists 2 linked publications.
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 13 Oct 2026.