Neoplasms

Symptoms and General Pathology

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Musculoskeletal Diseases

Rare Diseases

Neoplasm Metastasis

Lung Neoplasms

Disease Progression

Spinal Cord Neoplasms

Ependymoma

Spinal Neoplasms

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Spinal Cord Diseases

Bone Neoplasms

Bone Diseases

Spinal Diseases

Neuroepithelioma

According to the site to irradiate and to local constraints, SBRT consist in 1 to 8 fractions of 5 to 18 Gy

For Brain metastasis the SBRT treatment consists on 3 fractions of 8 Gy or 5 fractions of 7 Gy or 1 fraction of 18 Gy for a single metastasis which is less than 20 mm.

For primary or secondary pulmonary tumors the SBRT treatment consists on 3 fractions of 15 Gy or 5 fractions of 10 Gy for peripheral lesions and on 5 fractions of 8 Gy for proximal lesions.

For primary or secondary spinal or para-spinal tumors the SBRT treatment consists on 3 fractions of 9 Gy or 5 fractions of 7 Gy.

For previously irradiated tumors (same locations) the SBRT treatment consists on 5 to 8 fractions of 5 Gy.

For relapsed Ependymoma previously irradiated the SBRT treatment will be allocated by surgical stratified randomization and consists on either 3 fractions of 8 Gy or 5 fractions of 5 Gy.

SBRT treatment

Line CLAUDE, Doctor

The purpose of this study is to evaluate the efficacy of hypofractionated stereotactic radiation treatments (SBRT) on children, teenagers and young adults malignant tumors.

SBRT (Stereotactic Body Radiation Therapy) is a radiotherapy treatment which involves the delivery of a single high dose radiation treatment or a few fractionated radiation treatments (usually up to 5). A high potent biological dose of radiation is delivered to the tumor improving the cure rates for the tumor, in a manner previously not achievable by standard conventional radiation therapy.

For adult patients, the "Haute Authorité de Santé" (HAS) validates some indications for this treatment which are the followings :

* Few primary or secondary brain tumors, which cannot be surgically removed
* Spinal tumors
* Primary bronchopulmonary tumors T1 T2 N0 M0 and pulmonary metastasis with slow growth and controled primary tumor.

For pediatrics patients, no indication is now validated by HAS. Indications validated for adults are rare in pediatrics but not exceptional, and in such cases efficient alternative treatments does not exist.

In consequence, and regarding the good results obtained in adult patients, it seems very important to validate the efficacy of this treatment on pediatrics population

Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics)

Hypofractionated Stereotactic Radiation Treatments (SBRT) on Children, Teenagers and Young Adults Malignant Tumors

The SBRT treatment related costs will be evaluated by a "microcosting" method which take into account, in particular, the irradiation duration seance, the time for the mobilized staff, the kind of equipment required, the duration of related AE hospitalizations.

2 modalities of SBRT are compared in patients with an ependymoma (3 fractions of 8 Gy versus 5 fractions of 5 Gy). It will be calculated the cost/efficacity ratio for the avoided toxicity 6 months after SBRT.

The costs will be evaluated by the data from french social security system, from homogeneous group of patients and from general classification of professional acts

2 modalities of SBRT are compared in patients with an ependymoma (3 fractions of 8 Gy versus 5 fractions of 5 Gy). It will be calculated :

* the cost/efficacity per gained year of life without relapse after 12 months after SBRT
* the cost/efficacity per gained year of life without disease after 12 months after SBRT.

The costs will be evaluated by the data from french social security system, from homogeneous group of patients and from general classification of professional acts

2 modalities of SBRT are compared in patients with an ependymoma (3 fractions of 8 Gy versus 5 fractions of 5 Gy). It will be calculated :

* the cost/efficacity per gained year of life without relapse after 24 months after SBRT
* the cost/efficacity per gained year of life without disease after 24 months after SBRT.

The costs will be evaluated by the data from french social security system, from homogeneous group of patients and from general classification of professional acts

The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (complete response + partial response + stable disease)

The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to RECIST version 1.1 criteria (complete response + partial response + stable disease) between 1,5 and 3 months after treatment

Calculated from the date of inclusion to the date defined as the first documented disease progression, or second cancer appearance, or death from any cause (Up to 5 years since the first inclusion)

Calculated from the date of inclusion to the date of death from any cause (Up to 5 years since the first inclusion)

Toxicities appeared during SBRT treatment and up to 3 months after SBRT. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Toxicities appeared after 24 months after inclusion. The outcome measure concerns toxicities appeared after the study following period. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to RECIST version 1.1 criteria (complete response + partial response + stable disease) at 12 months after treatment

The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to RECIST version 1.1 criteria (complete response + partial response + stable disease) at 24 months after treatment

Toxicities appeared between 3 months and 24 months after treatment. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Centre Leon Berard

Behaviors and Mental Disorders

Pain

Quality of Life

Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.

STAR™ Tumor Ablation System

Radiofrequency-targeted vertebral augmentation (RF-TVA)

StabiliT® Vertebral Augmentation System

Jack Jennings, MD

The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.

Prospective, multi-center clinical study. Stratification scheme: 'Failed/Refused Further RT' and "No Previous RT"

Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)

Evaluation of Targeted Radiofrequency Ablation and Vertebral Augmentation Prior to or Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s) [The STARRT Study]

The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Primary outcome is measuring the mean change from baseline in BPI worst pain score at 6 weeks.

Measured by Brief Pain Inventory (BPI) Pain Q3, The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is measuring the mean change from baseline in BPI worst pain score prior to 6 weeks.

The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is the response to Q3 at Weeks 1, 2 and 6.

DFINE Inc.

Merit Medical Systems, Inc.

All cause mortality was collected. Of 35 enrolled subjects, 9 died due to disease progression and 2 died due to other reasons (one was listed as hospice and the other as "unknown"). There were 0 participants considered to have experienced Serious Adverse Events (SAEs) and the participants who died due to disease progression and other reasons are not considered SAEs.

Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.

STAR™ Tumor Ablation System: Targeted-radiofrequency ablation (t-RFA)

StabiliT® Vertebral Augmentation System: Radiofrequency-targeted vertebral augmentation (RF-TVA)

No Previous Radiation Therapy

Failed/Refuse Further Radiation Therapy

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Breast Cancer

Prostate Cancer

Prostate Cancer and Other

Small Cell Lung Cancer

Non-Small Cell Lung Cancer

Thyroid Cancer

Other

Primary Cancer

The BPI asks subjects to rate pain by circling the one number that best describes pain at its worst in the last 24hrs. 0=no pain and 10=pain as bad as (you) can imagine. Results are presented in response to Q3 of the BPI only (i.e. pain at its worst in the last 24hrs). This was accomplished using the BPI short form.

Brief Pain Inventory (BPI -Short Form) - 24 hour worst pain

Study was terminated due to difficulty with enrollment. Analysis of data is limited due to early termination of study and incomplete enrollment and completion of study subjects.

Casey Holland

Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks

Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks

Week 1

Week 2

Week 6

Brief Pain Inventory Q3 Worst Pain Score by Visit

Overall Study

15 Gy dose in one stereotactic body radiation treatment

25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment

Stereotactic Body Radiation Therapy

Robert J Amdur, MD

The purpose of this research study is to determine if Stereotactic Body Radiation Therapy (SBRT) is a good way to treat tumors near the spinal cord. Patients will either receive a single treatment or 25 days of treatment given once-a-day, Monday through Friday for about 5 continuous weeks. Our protocol uses life expectancy, patient preference, and tumor size to determine whether SBRT is delivered with 1 or 25 treatments. The single treatment dose is 15 Gy. The 25 treatment group is 70 Gy at 2.8 Gy/treatment.

This protocol is a study of the use of Stereotactic Body Radiation Therapy (SBRT) for all types of primary or metastatic tumors near the spinal cord. The major goal of this study is to evaluate the efficacy and toxicity of a specific SBRT program in a prospective manner. The main outcome variables in this study are pain and neurologic function.

A major issue in delivering SBRT is the number of treatment sessions. There are advantages and disadvantages to both single and multi treatment programs. In this protocol, patients are offered SBRT with either a single treatment or 25 treatment days. This study is not designed to compare different SBRT schedules. A single treatment program is more convenient and likely to relieve symptoms sooner than a multi-session program. A program with 25 treatments may produce better long-term results. Our protocol uses life expectancy, patient preference, and tumor size to determine whether SBRT is delivered with 1 or 25 treatments.

Stereotactic Body Radiation Therapy (SBRT) for Tumors Near the Spinal Cord

Stereotactic Body Radiation Therapy for Tumors Near the Spinal Cord

Toxicities were graded using the RTOG-EORTC (Radiation Therapy Oncology Group-European Organization for Research and Treatment of Cancer) system and a descriptive system with which we coded any complication as mild, moderate, or severe based on our informal assessment of the complication's effect on overall quality of life. We assessed toxicity as "acute" meaning during treatment and "late" meaning several months after treatment ended.

Number of tumor sites with no evidence of progression of tumor at the site of radiosurgery

Number of patients with a change in neurological function of those who presented with a neurologic deficit from tumor compression. The McCormack score was noted for each patient and the interval change was determined informally as no neurological deficit, better, worse, or unchanged as noted below.

Number of patients who reported pain at baseline and reported experienced relief after treatment. Pain was defined on a 10 point scale with 0 being no pain and 10 being worst pain imaginable. Pain relief is defined as reporting a lower level of pain than that reported at baseline.

Number of patients alive at one year after treatment

University of Florida

15 Gy dose of radiation in one treatment. Patients were offered the option of which arm they wished to participate in.

Single Treatment Group

25 treatments, given once a day, Monday through Friday for about five weeks; Dose: 70 Gy at 2.8 Gy/treatment. Patients were offered the option to participate in which arm they preferred.

25 Treatments Group

<=18 years

Between 18 and 65 years

>=65 years

Age Categorical

Age Continuous

Female

Male

Gender

United States

Region of Enrollment

Bridget Fitzgerald, Clinical trials coordinator

mild acute toxicity

moderate acute toxicity

severe acute toxicity

Late toxicity

Toxicity

25 Treatments Grouop

Local Control

improved neurologic function

unchanged neurologic function

worse neurologic function

6 patients presented with tumor-related deficits before treatment.

Neurologic Function

Pain Relief

Overall One Year Survival

Wounds and Injuries

Spinal Cord Compression

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Anesthetics

Melphalan

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Subjects recruited to this study will receive intra-arterial injections of chemotherapy (melphalan) in the branches of the arteries feeding the metastatic spinal tumor. Subjects will receive general anesthesia or conscious sedation. A catheter will be guided using X-ray from the femoral artery at the top of the leg to the arteries of the spine. A dye will be injected through the catheter to show the arteries in greater detail. The chemotherapy is then injected into the tumor. We will inject the maximum systemic dose adjusted to white blood count and platelet count. Subjects will undergo three cycles of chemotherapy three to six weeks apart.

Patients will undergo a minimally invasive procedure called spinal angiography. This procedure will identify the arteries feeding the tumor causing cord compression and will determine whether chemotherapy can be safely infused.

The chemotherapy will be infused via a tiny soft plastic tube (called "microcatheter") at the tumor site over approximately 30 minutes.

The drug of choice is melphalan (trade name Alkeran) at a maximum dose of 16mg/m2, adjusted for white cell count, platelet count and renal function.

We will perform up to three intra-arterial chemotherapy treatments in 3-6 week intervals, based on the results of complete blood counts.

Melphalan (intra-arterial infusion)

Athos Patsalides

Metastatic malignant tumors comprise the vast majority of spinal tumors in adults. The most devastating complication of spinal metastatic disease (SMD) is invasion of the spinal canal and compression of the spinal cord or the nerve roots of the cauda equina, resulting in a clinical entity known as cord compression that manifests with progressive loss of motor function and sensation in the legs, as well as bladder and bowel incontinence.

The treatment of spinal metastases is mostly palliative with the goals of improving or maintaining neurologic function, achieving local tumor control, and spinal stability. Most patients with spinal metastatic disease are currently treated effectively with radiation therapy and/or surgery with good results. There are however certain limitations in the current treatment of SMD. Radiation therapy has two important limitations: 1) if the targeted SMD is in close proximity the spinal cord, delivery of high radiation doses is contraindicated as it may cause radiation-induced damage to the spinal cord (myelopathy, and 2) there is limit on the cumulative amount of radiation dose, which means that recurrent tumors may not be amenable to repeat radiation therapy. As far spinal surgery is concerned, the main limitation is that some patients are not fit for surgery because of medical co-morbidities.

This phase I clinical research trial will test the hypothesis that a new minimally invasive treatment called spinal intra-arterial chemotherapy (SIAC) can be safely applied in patients with SMD.

To date, there is no effective systemic therapy for spinal metastases, and the goal of treatment is to achieve local control of the tumor. Despite advances in radiation therapy, there is still a subgroup of patients that cannot be effectively treated with radiation because of close proximity of the tumor to the spinal cord. In addition, in cases of recurrent tumors, some patients cannot be re-treated because they reached the maximum allowed radiation dose. Surgery is the alternative treatment for these patients, but some tumors do recur after surgery while some patients have comorbidities that make surgery a high-risk procedure.

Based on our prior experience with selective IA chemotherapy for the treatment of ocular retinoblastoma and the high local control rates achieved with selective IA injection of chemotherapy in recurrent limb melanoma (limb infusion and limb perfusion) we expect that spinal intra-arterial chemotherapy with selective injection of Melphalan in the arteries feeding the metastatic disease is feasible and safe and may prove beneficial in achieving local control of the spinal tumor, preventing neurological compromise from cord compression. This minimally invasive approach can be used in patients in whom radiation therapy and surgery are contra-indicated and essentially have no other treatment options.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of SBRT Efficacy on Intra and Extra -Cranial Tumors or Metastasis in Pediatrics Population (SBRT Pediatrics)	NCT02013297	Brain Metastasi... Spinal Tumors Lung Tumors Ependymoma	SBRT treatment	18 Months - 20 Years	Centre Leon Berard
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)	NCT02225223	Metastatic Lesi...	STAR™ Tumor Abl... StabiliT® Verte...	18 Years -	Merit Medical Systems, Inc.
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)	NCT02225223	Metastatic Lesi...	STAR™ Tumor Abl... StabiliT® Verte...	18 Years -	Merit Medical Systems, Inc.
Stereotactic Body Radiation Therapy (SBRT) for Tumors Near the Spinal Cord	NCT00631670	Spinal Tumors	Stereotactic Bo... Stereotactic Bo...	-	University of Florida
Stereotactic Body Radiation Therapy (SBRT) for Tumors Near the Spinal Cord	NCT00631670	Spinal Tumors	Stereotactic Bo... Stereotactic Bo...	-	University of Florida
Intra-arterial Chemotherapy for Spinal Metastases	NCT01637766	Spinal Diseases Spinal Metastas... Spinal Tumors	Melphalan (intr...	18 Years - 80 Years	Weill Medical College of Cornell University

Spots Global Cancer Trial Database for spinal tumors