Clinical trial NCT02713269: Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
Official title: A Phase II Clinical Trial Evaluating the Efficacy of Combining Thermal Ablation and Spine Stereotactic Radiosurgery for Patients With Spine Metastases With Moderate to Severe Epidural Involvement
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Malignant Digestive System Neoplasm
Metastatic Head and Neck Carcinoma
Metastatic Kidney Carcinoma
Metastatic Malignant Neoplasm in the Spine
Metastatic Malignant Neoplasm of Unknown Primary
Metastatic Melanoma
Prostate Carcinoma Metastatic in the Bone
Sarcoma
Solid Neoplasm
Spinal Cord Compression
Stage IV Breast Cancer AJCC v6 and v7
Stage IV Lung Non-Small Cell Cancer AJCC v7
Thyroid Gland Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion:

* At least 18 years of age.
* Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive histologic subtypes, see Exclusion Criteria), including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors.
* Quantification of the degree of epidural spinal cord compression as grade 1C, 2, or 3 by MRI, with and without contrast sequences. Axial T2 sequence is encouraged but not required.
* The vertebral body site to be treated must be located from T2-T12.
* No more than 3 contiguous or discontiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session or 3 sessions.
* Motor strength \>/=4 out of 5 in extremity or extremities affected by the level of the spinal cord compression (see section 4 for grading method).
* ECOG performance status \</=2 or Karnofsky performance status (KPS) \>/=50
* Life expectancy \>3 months.
* Inoperable disease because of patient refusal, neurosurgical evaluation, or any other medical reasons.
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
* Prior conventional radiation to the same site is allowed as long as there is a greater than 3 months interval.
* All patients must sign informed consent forms verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of MD Anderson Cancer Center. The only acceptable consent form is one approved by the MD Anderson institutional review board.
* Patients who do not have other options of treatment, based on consensus recommendation of the multidisciplinary spine SRS (SSRS) tumor board. Patients will have an appropriate medical oncologist for their disease.

Exclusion:

* Primary tumors of radiosensitive histology (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors), as conventional radiation is likely to be effective in such cases.
* Prior conventional irradiation of the spine site and level to be treated with an interval shorter than 3 months.
* Lesions located outside of the spinal segments of T2 to T12.
* Prior surgery to the same levels of spine.
* Inability to lie flat on a treatment table for \>60 minutes.
* Unable to undergo MRI of the spine
* Pregnancy (because radiation has the potential for teratogenic or abortifacient effects).
* Frank cord compression or cord compression from bone components or configuration and acute neurological deficits (defined as motor strength \<4/5 in extremity or extremities affected by the level of the spinal cord compression).

Primary outcomes:
measure: Local tumor control rate
timeFrame: At 6 months
Secondary outcomes:
measure: Local tumor control
timeFrame: Up to 24 months
measure: Epidural control assessed by volumetric measurements
timeFrame: Up to 24 months
measure: Overall survival
timeFrame: Up to 24 months
measure: Changes in symptoms assessed by physical examination
timeFrame: Baseline to 24 months
measure: Changes in symptoms assessed by neurological examination
timeFrame: Baseline to 24 months
measure: Changes in quality of life (QOL) assessed by the MD Anderson Symptom Inventory Spine Tumor form
timeFrame: Baseline to 24 months
measure: Changes in quality of life (QOL) assessed by Brief pain inventory (BPI) form
timeFrame: Baseline to 24 months
measure: Changes in quality of life (QOL) assessed by SF-12 healthy survey (v2)
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jing Li
role: PRINCIPAL_INVESTIGATOR
References: