Neoplasms

Nervous System Diseases

All Conditions

Musculoskeletal Diseases

Spinal Cord Neoplasms

Spinal Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Spinal Cord Diseases

Central Nervous System Diseases

Bone Neoplasms

Bone Diseases

Spinal Diseases

Hypofractionated stereotactic radiosurgery

Cyberknife stereotactic radiosurgery

Yongye Chen, MS

This study aims to explore the reliability of the combination of functional magnetic resonance imaging and radiomics for evaluation of the therapeutic efficacy of CyberKnife stereotactic radiosurgery for spinal tumors. Accurate imaging assessment can help clinicians plan personalized therapeutic schedules for patients with spinal tumors .

Spinal tumors may be metastases or primary tumors; the former are more common. About 40% of cancer patients will have spinal metastasis. Primary spinal tumor is relatively rare, accounting for only about 8% of spinal tumors. For both metastasis and primary tumor, the aim of treatment is to reduce pain, maintain or improve neurological function, and maintain or restore spinal stability.

In patients who cannot undergo surgery or need additional treatment after surgery, radiation therapy can relieve pain, prolong survival, improve the success rate of surgery, and reduce risk of metastasis and recurrence. However, the complex anatomy of the spine, and the numerous important organs around it, makes radiation treatment challenging. High-dose radiation therapy is necessary for long-term control of the tumor and for prevention of spinal column instability; however, this is impossible with traditional radiotherapy due to the presence of the radiosensitive spinal cord. Outcomes therefore tend to be poor for large and complex lesions. The CyberKnife-a stereotactic body radiation therapy (SBRT) platform that combines a lightweight linear accelerator, a robotic arm, an imaging system, and a respiratory tracking system-offers a feasible approach. It can achieve submillimeter level-precision treatment under imaging guidance.

Currently, the effectiveness of CyberKnife radiosurgery for spinal tumors is decided by assessing imaging changes, relief of clinical symptoms, and needle biopsy, but all of these methods have limitations. On imaging, for example, change in lesion volume is used to assess tumor regression, but the size of a spinal tumor is not easy to measure and, moreover, decrease in tumor volume after treatment may take time . Post-treatment signal intensity changes in conventional magnetic resonance imaging (MRI) T1-weighted and T2-weighted sequences are difficult to interpret, and their relationship with treatment efficacy is also not clear.

Generally speaking, alterations in microscopic structure and biological activity of the tumor occur much earlier than changes in gross morphology . Functional magnetic resonance imaging (fMRI) can therefore be more useful than conventional MRI for assessing treatment response. In fMRI, sequences such as diffusion-weighted imaging (DWI), dynamic contrast-enhanced MRI (DCE-MRI), and diffusion kurtosis imaging (DKI) reflect functional information of tissues from different perspectives.

Application of artificial intelligence technology for analysis of medical imaging data is now an area of intense research. This new method, which is called radiomics, can help in solving many difficult clinical problems. By extracting a large number of highly representative quantitative imaging features from high-throughput medical image data, radiomics can help in evaluating treatment efficacy and predicting prognosis of spinal tumors.

Investigators intend to explore the use of the combination of fMRI and radiomics for evaluating the effectiveness of CyberKnife radiosurgery for spinal tumors. The method will be able to evaluate both volume and functional changes in the tumor, and thus provide important information for planning of individualized therapeutic schedules for patients with spinal tumors.

Evaluation of Effectiveness of CyberKnife Stereotactic Radiosurgery for Spinal Tumors

Functional Magnetic Resonance Imaging Combined With Radiomics for Evaluation of Effectiveness of CyberKnife Stereotactic Radiosurgery for Spinal Tumors

The time from the start of treatment to the date of death or last follow-up

The time from the start of treatment to the date of diagnosis of tumor progression or death. Tumor progression is defined as increase in lesion volume on MRI compared to baseline, or identification of new metastasis on imaging or histological examination.

A 11 point scale where the end points are the extremes of no pain and pain as bad as it could be, or worst pain.

The QLQ-C30 is a cancer-specific, self-administered, structured questionnaire designed for use in clinical trials, which contains 30 questions (items),

Peking University Third Hospital

Digestive System Diseases

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

In this group ,the participants receive the dose fraction of 49Gy/7f (BED 83.3Gy) by cyberknife.

In this group ,the participants receive the dose fraction of 54Gy/6f(BED 102.6Gy) by cyberknife.

In this group ,the participants receive the dose fraction of 55Gy/5f(115.5Gy) by cyberknife.

The investigators divide the participants randomly into 3 groups by SPSS 19.0.Three groups participants receive the different dose fraction(49Gy/7f,54Gy/6f and 55Gy/5f),which also means different Biologic Equivalent Dose.Through the research,the investigators want to find out the optimum dose fraction method,which makes the treatment safe, effective and personalized.

Dose fraction forms

The research aims to the primary hepatic carcinoma patients whose diameter of the single tumor is equal or less than 5cm.By supervising the changes of liver function, Child-Pugh score, ICG-R15 value, secondary reaction, incidence rate of RILD during and after the radiotherapy, meanwhile combining the outcome of the progression of disease and the condition of survival quality, the optimum proposal could be obtained and apply to clinic thus make the treatment safe, effective and personalized.

On the Cyberknife Dose Fraction of Liver Cancer Treatment

Local control illustrates the time from the tumor appearance to progress (the diameter more than or equal to 1.5 times of original) .The ratio of the number of the local control patients to the whole number of patients is local control rate.

Overall survival rate means the ratio of the number of patients who are alive to the whole patients after the treatment.

the rate of radiotherapy induced liver disease

By testing the liver function,coagulation function and ascites,we could calculate the Child-Pugh score,which reflect the liver function roundly.

It means the indocyanine green retention rate at 15 minutes,which reflects the liver reserve.

Beijing 302 Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).

Treatment Planning:

Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the Planning Treatment Volume (PTV) and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.

CyberKnife radiosurgery

Sean P Collins, MD,PhD

Radiation therapy is a well-established treatment modality for clinically localized prostate cancer. Men who choose to undergo radiation treatments for prostate cancer will have to live with the side effects for many years. Attempts have been made to protect surrounding tissues while delivering high dosage of radiation to cancer. With the rectum being so close to the prostate, many patients still suffer from side effects caused by radiation injury to the rectum, especially those who received conventional external beam radiotherapy.

CyberKnife is an FDA approved radiosurgical devise. Its flexible robotic arm allows radiation beams to be delivered in different directions, providing a highly conformal, uniform dose with steep dose gradients. Therefore, treatment with the CyberKnife radiosurgical system should minimize the toxicity to the surrounding structures. CyberKnife System also incorporates a dynamic tracking system to allow the robot to correct the targeting of therapeutic beams during treatment. These improvements allow for dose escalation within the prostate with less normal tissue toxicity.

The purpose of this study is to estimate the proportion of patients with endoscopically detectable telangiectasia as the indication of radiation injury to the rectum, after CyberKnife Treatment for prostate cancer.

Radiation therapy is a well-established treatment modality for clinically localized prostate cancer. Current techniques include conventional external beam radiotherapy and intensity modulated radiation therapy (IMRT). The efficacy of conventional external beam radiation treatment (60-70 Gy in 2 Gy fractions) using several uniform fields has been documented. The 10-year disease-free survival rate for patients with disease confined to the prostate in the pre-Prostate Specific Antigen (PSA) era was approximately 50-70%. Analysis of these data suggested that dose escalation could improve local control in prostate cancer.

On average, men who choose to undergo radiation therapy treatments for prostate cancer will have to live with the side effects of therapy for many years. Chronic proctitis may occur after radiotherapy (RT) to the pelvic region. According to a published series, it clinically occurs after radiation therapy of localized prostate cancer at a frequency of 5-20%. It occurs months to years after treatment (average 8-12 months) with a large majority within two years following radiation therapy. Patient characteristics, such as a history of inflammatory bowel disease or chronic anticoagulation therapy, may increase an individual patient's risk of clinically significant proctitis. Patients with radiation-induced proctopathy have described symptoms of rectal pain, diarrhea, urgency, rectal bleeding, and increased frequency of bowel movements. Endoscopic evaluation shows telangiectasia, congested mucosa and ulcers. Rectal bleeding occurs from the neovascular telangiectasia seen in about 60% of patients receiving conventionally fractionated radiation therapy. The other symptoms probably develop from the decreased rectal compliance associated with rectal wall fibrosis. These symptoms are, in current reports, most often classified according to the NCI Common Toxicity Criteria grade for late gastrointestinal side effects. Due to the proximity of the rectum and bladder to the prostate, using conventional techniques, the prescription dose is limited to 65-70 Gy. Although attempts were made to protect the rectum, the incidence of rectal bleeding was unacceptable at doses greater than 70 Gy (20%).

The risk of proctitis and rectal bleeding appeared to be dependent upon both the radiation dose and the volume of the rectum in the high dose area. Radiation Oncologists' efforts to optimize the therapeutic ratio for prostate cancer treatment have therefore been directed toward limiting the high dose volume to the prostate while escalation the dose within that volume. Intensity modulated radiation therapy (IMRT) is a widely used technology to achieve this goal. It is accomplished by modulating the radiation beam intensity within each radiation field in accordance with an optimization algorithm. This has allowed greater dose-escalation without evident increase in acute complications, although follow-up is too short to fully assess control and complication rates. Whether IMRT will provide a degree of conformity that proves to eradicate prostate cancer with a high probability while sparing local structures is as yet unresolved.

Late Rectal Mucosal Injury Following CyberKnife RadioSurgery for Clinically Localized Prostate Cancer. The type, extent and incidence of rectal mucosal injury following CyberKnife radiosurgery are currently unknown. The severity of clinical proctitis following radiation therapy is commonly documented using the NCI Common toxicity criteria/Radiation Therapy Oncology Group/EORTC. Unfortunately, clinical proctitis has a low sensitivity for detecting rectal mucosal injury. Endoscopy gives the most accurate estimate of the extent and incidence of rectal mucosal injury. The Vienna rectoscopy score (VRS) was developed to quantify rectal mucosal changes following radiation therapy. In this study, endoscopic evaluation of mucosal damage from CyberKnife treatment will be documented and correlated with gastrointestinal side effects and treatment planning parameters.

Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer

Prospective Endoscopic Safety Evaluation of Late Rectal Mucosal Injury Following CyberKnife Radiosurgery for Clinically Localized Prostate Cancer

Telangiectasia is the primary outcome since it is a measure of tissue fibrosis (primary source of proctitis) and is a well-defined and measurable outcome.

No patients had outcome before the trial was terminated.

Progression-free survival will be defined as the time in months from study entry until progression or death. Patients who are alive and free from progression on the date of closing follow-up will be censored on that date. Data table reports the number of participants who were alive without progression at the end of the study.

Georgetown University

Assistant Professor

A total of 4 subjects out of 40 were accrued for this study. None of the 4 subjects have experienced any adverse events since the start of this study.

CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).

CyberKnife radiosurgery: Treatment Planning:

Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.

CyberKnife Radiosurgery, Colonoscopy

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Sean Collins

Proportion of Patients With Endoscopically Detectable-telangiectasia (VRS Grade 1 or Higher).

CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).

CyberKnife radiosurgery: Treatment Planning:

Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the Planning Treatment Volume (PTV) and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively.

No patients had outcome before the trial was terminated.

Proportion of Patients With Rectal Bleeding.

Progression-free Survival

Overall Study

36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction

CyberKnife Radiosurgery

Shermian Woodhouse, MD

The purpose of this study is to determine the effects of CyberKnife radiosurgery in patients with early stage prostate cancer.

The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife® can deliver tumor ablating doses of radiation to prostate tumors safely and effectively while sparing the adjacent tissues (rectum, bladder, ureters, urethra, penile bulb, and bowel) from receiving damaging doses of radiation.

The CyberKnife system is a type of radiation machine that uses a special system to precisely focus large doses of x-rays (radiation) on the tumor. The device is designed to concentrate large doses of radiation onto the tumor so that injury from radiation to the nearby normal tissue will be minimal.

A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors

Prospective Evaluation of CyberKnife Stereotactic Radiosurgery for Low and Intermediate Risk Prostate Cancer: Emulating Homogenous Dose Distribution

* To assess the effects of hypofractionated stereotactic radiosurgery on the long-term local tumor control of prostate cancer (through documentation of the rate of biochemical Disease-Free Survival \[bDFS\], Phoenix and ASTRO definitions, at 5 and 10 years).
* To document the rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicity observed during the years following CyberKnife SRS for prostate cancer.

To measure the following in the study population: rates of local failure, distant failure, disease-free survival, disease-specific survival; quality of life (QOL) in generic and organ-specific domains.

Community Cancer Center, Normal, Illinois

Eye Diseases

Brain Neoplasms

Optic Nerve Neoplasms

Peripheral Nervous System Neoplasms

Cranial Nerve Diseases

Optic Nerve Diseases

25 Gy delivered in 5 fractions of 5 Gy per fraction

The purpose of this study is to find out what effects (good and bad) CyberKnife stereotactic radiosurgery has on tumors near the critical structures of the eye (optic apparatus).

The investigators hypothesize that hypofractionated stereotactic radiotherapy via the CyberKnife ® can deliver tumor ablating doses of radiation to perioptic lesions safely and effectively while sparing the adjacent optic apparatus and normal brain tissues from receiving damaging doses of radiation.

A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors

A Phase II Study of Fractionated CyberKnife Stereotactic Radiosurgery to Perioptic Tumors

To determine the local control rate of patients with perioptic lesions treated with stereotactic CyberKnife radiosurgery.

Carlyn A Tripp

Donald B Fuller, M.D.

Virtual high dose rate (HDR) CyberKnife (CK) prostate treatment has comparable morbidity and efficacy compared with actual prostate HDR treatment, but does it without the catheters and hospital admission. As such, it is a more "patient friendly" treatment method compared with actual prostate HDR brachytherapy as currently practiced. Related, as has previously been reported with actual prostate HDR treatment, Virtual HDR CyberKnife prostate treatment should have a high efficacy but with lower acute and chronic morbidity compared with other local prostate cancer treatment methods such as permanent seed prostate brachytherapy.

Brachytherapy is a form of treatment where a radioactive isotope is implanted directly into a tumor volume to deliver a lethal dose of radiation. High Dose Rate (HDR) Prostate brachytherapy is a particularly elegant brachytherapy dose sculpting method that is effectively used in the curative treatment of prostate cancer; however, it requires hospital admission and many temporarily implanted transperineal catheters to deliver the radiation source to the target volume, resulting in significant patient discomfort. CyberKnife delivers a form of radiation treatment that is so precise, it appears capable of reconstructing HDR prostate radiation dose sculpting, without the hospital admission and without the catheters. The CyberKnife device is also used for classic radiosurgery, with accuracy comparable to the Gamma Knife, but unlike the Gamma Knife, has the capability to target lesions anywhere in the body with similar accuracy. The aim of this study is to compare CyberKnife morbidity and efficacy with that of HDR and other local treatment methods such a permanent seed prostate brachytherapy in the treatment of prostate cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Effectiveness of CyberKnife Stereotactic Radiosurgery for Spinal Tumors	NCT04192383	Spinal Neoplasm...	Cyberknife ster...	-	Peking University Third Hospital
On the Cyberknife Dose Fraction of Liver Cancer Treatment	NCT03295500	CyberKnife Radi...	Dose fraction f...	30 Years - 80 Years	Beijing 302 Hospital
Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer	NCT01618838	Stage II Prosta...	CyberKnife radi...	18 Years -	Georgetown University
Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer	NCT01618838	Stage II Prosta...	CyberKnife radi...	18 Years -	Georgetown University
A Phase II Trial of CyberKnife Stereotactic Radiosurgery to Prostate Tumors	NCT02225262	Prostate Cancer Cancer of the P... Prostate Neopla...	CyberKnife Radi...	21 Years -	Community Cancer Center, Normal, Illinois
Evaluation of Effectiveness of CyberKnife Stereotactic Radiosurgery for Spinal Tumors	NCT04192383	Spinal Neoplasm...	Cyberknife ster...	-	Peking University Third Hospital
A Phase II Trial of CyberKnife Radiosurgery to Perioptic Tumors	NCT02225197	Tumor, Benign, ...	CyberKnife Radi...	21 Years -	Community Cancer Center, Normal, Illinois
CyberKnife Radiosurgery for Localized Prostatic Carcinoma	NCT01045148	Prostate Cancer	CyberKnife Radi... CyberKnife Radi...	18 Years -	CyberKnife Centers of San Diego
CyberKnife Radiosurgery for Localized Prostatic Carcinoma	NCT01045148	Prostate Cancer	CyberKnife Radi... CyberKnife Radi...	18 Years -	CyberKnife Centers of San Diego
Endoscopic Evaluation of Late Rectal Injury Following CyberKnife Radiosurgery for Prostate Cancer	NCT01618838	Stage II Prosta...	CyberKnife radi...	18 Years -	Georgetown University

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