A Phase 2 interventional study of Computed Tomography and Quality-of-Life Assessment in Malignant Digestive System Neoplasm, Metastatic Head and Neck Carcinoma and Metastatic Kidney Carcinoma, sponsored by M.D. Anderson Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
This phase II clinical trial studies how well thermal ablation and spine stereotactic radiosurgery work in treating patients with cancer that has spread to the spine (spine metastases) and is at risk for compressing the spinal cord. Thermal ablation uses a laser to heat tumor tissue and helps to shrink the tumor by destroying tumor cells. Stereotactic radiosurgery delivers a large dose of radiation in a short time precisely to the tumor, sparing healthy surrounding tissue. Combining thermal ablation with stereotactic radiosurgery may be a better way to control cancer that has spread to the spine and is at risk for compressing the spinal cord.
PRIMARY OBJECTIVE:
I. To document the rate of local control at 6 months in patients who receive a combination of thermal ablation and stereotactic spine radiosurgery (SSRS) for spine metastases with moderate to severe epidural involvement.
SECONDARY OBJECTIVES:
I. To determine local control at 1, 3, 9, 12, 18, and 24 months, and to compare to a historical control where patients received only SSRS at these time points and at 12 months.
II. To document the extent of epidural tumor regression at 1, 3, 6, 9, 12, 18 and 24 months.
IIa. Calculate decrease in epidural tumor volume (by volumetric measurements). IIb. Calculate increase in thecal sac patency (by volumetric measurements and according to Bilsky method).
III. To determine overall survival at 6, 12, 18, and 24 months. IV. To assess changes in muscle strength, location and severity of spinal-related pain, sensory function, ability to ambulate, and neurological grading at 1, 3, 6, 9, 12, 18, and 24 months compared with pretreatment baselines.
V. To assess the effect of treatment on quality of life (QOL), measured at 1 month and every 3 months after with validated outcome measure tools.
VI. To describe adverse side effects after treatment and to descriptively correlate those effects with radiographic findings, pain control, and quality of life.
OUTLINE:
Patients undergo thermal ablation and computed tomography (CT)-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months.
695 studies on the registry are indexed under Gastrointestinal Neoplasms; 209 are open to participants now.
This study's enrollment of 60 is below the median of 74 across 494 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergo thermal ablation and CT-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.
Procedure: Computed Tomography · Other: Quality-of-Life Assessment · Other: Questionnaire Administration · Radiation: Stereotactic Radiosurgery · Procedure: Thermal Ablation Therapy
Undergo CT scan
Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Undergo CT-guided SSRS
Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery
Undergo thermal ablation therapy
Also known as: thermal ablation
Local tumor control rate
Kaplan-Meier estimates will be used.
Time frame: At 6 months
Local tumor control
Kaplan-Meier estimates will be used. Time to local failure will be monitored continuously using a Bayesian method. Cumulative incidence of local failure will be estimated failure treating death without failure as a competing risk. Propensity score analyses will be used to compare the thermal ablation cohort with a historical cohort where patients received only stereotactic spine radiosurgery (SSRS).
Time frame: Up to 24 months
Epidural control assessed by volumetric measurements
Extent of epidural tumor regression be determined by change in epidermal tumor volume and change in thecal sac patency (by volumetric measurements and according to Bilsky method). Kaplan-Meier estimates will be used. Cumulative incidence of epidural failure will be estimated failure treating death without failure as a competing risk. Propensity score analyses will be used to compare the thermal ablation cohort with a historical cohort.
Time frame: Up to 24 months
Overall survival
Kaplan-Meier estimates will be used.
Time frame: Up to 24 months
Changes in symptoms assessed by physical examination
The Physical exam includes general exam, (HEENT) Head, Eye, Ear, Nose and Throat evaluation, chest, heart, abdomen and extremities exam. Combined with the neurotically examination results, changes at 1, 3, 6, 9, 12, 18, and 24 months will be compared with pretreatment baselines. Patients with negative changes will be evaluated by the neurosurgeon and radiation oncologist to determine if the change is related to a local failure/complication or to progression of systemic disease. Kaplan-Meier estimates will be used.
Time frame: Baseline to 24 months
Changes in symptoms assessed by neurological examination
The neurological exam includes (1) mental status (tested through history taking), (2) cranial nerves (Observation of eyes, face, voice, and coordination during history taking and as patient moves about the exam room. Look for extraneous movements), (3) motor system (visual inspection, tone, muscle strength and endurance, assigned score of 0-5 for each muscle, a score of 0 would mean no muscular contraction, and a score of 5 would mean movement against full resistance, normal strength), (4) reflexes, (5) sensory system (vibration in toes; pinprick in feet; (6) coordination (Truncal stability, fine finger movement, toe tapping, finger-nose-finger, heel-knee-shin), and (7) station and gait (Gait including arising from chair without hands, walking on toes, heels, and heel to toe). Kaplan-Meier estimates will be used.
Time frame: Baseline to 24 months
Changes in quality of life (QOL) assessed by the MD Anderson Symptom Inventory Spine Tumor form
Participants are asked to recall symptom severity and interference during the past 24 hours. Part I, The severity of the symptoms, including pain, fatigue, nausea, disturbed sleep, short of breath etc. Part II, How have the symptoms interfered with patient life, including mood, work, relations with other people etc. Part I, range 0-10. A score of 0 would mean the symptom is not present and a score of 10 means the symptom is as bad as you can imagine). Part II, range 0-10 (A score of 0 would mean the symptom did not interfere; A score of 10 means the symptom has interfered completely).
Time frame: Baseline to 24 months
Changes in quality of life (QOL) assessed by Brief pain inventory (BPI) form
Participants are asked to assess the severity of pain and the impact of pain on daily functions. Severity of pain, including the pain location, worst pain in last 24 hours, least pain in last 24 hours, pain on average and pain right now. Range 0-10. A score of 0 would mean no pain and a score of 10 means the pain is as bad as you can imagine. Pain medications, amount of pain relief in the past 24 hours, and impact of pain on daily function, including general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life, and Range 0-10.
Time frame: Baseline to 24 months
Changes in quality of life (QOL) assessed by SF-12 healthy survey (v2)
Participants are asked to twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). 3 and 5 point Likert scale is used in the survey. Two summary scores of the SF-12v2-physical and mental health-using the weighted means of the eight domains. Descriptive statistics will be used to summarize pain relief and quality of life at each follow-up visit, which will be the changes in scores from baseline to each assessment visit. Time to maximum pain relief will be the time from the day of thermal ablation until the lowest pain score for average pain after radiotherapy.
Time frame: Baseline to 24 months
Started Aug 2016 (actual). Primary completion is estimated for Oct 2027, 133 months after the start.
Of 55 phase 2 interventional studies under Gastrointestinal Neoplasms, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 73. This study's planned 133 months is above that.
How these figures are worked out, and which studies are left out of them.
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 active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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