An interventional study of Triple-target stereotactic radiosurgery and Sham radiosurgery in Cancer Pain and Refractory Pain, sponsored by Centro Internacional del Cáncer. Terminated at 1 site in El Salvador. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Centro Internacional del Cáncer · Not applicable, Interventional, and Supportive care
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.
343 studies on the registry are indexed under Cancer Pain; 74 are open to participants now.
This study's enrollment of 10 is below the median of 60 across 257 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →This is the only study on the registry with Centro Internacional del Cáncer as lead sponsor.
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Exclusion Criteria:
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.
Radiation: Triple-target stereotactic radiosurgery
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.
Procedure: Sham radiosurgery
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.
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.
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.
Time frame: Baseline and 15 days
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.
Time frame: 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.
Time frame: Up to 12 months
Plan to share: 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.
Supporting information: Study protocol, Analytic code
Time frame: Beginning at publication and ending 5 years thereafter
Access criteria: Requests must state the proposed use; access requires approval by the National Ethics Committee of El Salvador and a signed data-use agreement.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is terminated, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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