Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy

CyberKnife Stereotactic Radiotherapy

Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings

Surgery

Jack Roth, M.D.

Lung cancer remains the most frequent cause of cancer death in both men and women in the world. Surgical resection using lobectomy with mediastinal lymph node dissection or sampling has been a standard of care for operable early stage NSCLC. Several studies have reported high local control and survival using SBRT in stage I NSCLC patients. SBRT is now an accepted treatment for medically inoperable patients with stage I NSCLC and patients with operable stage I lung cancer are entered on clinical protocols. The purpose of this study is to conduct a phase III randomized study to compare CyberKnife SBRT with surgery, the current standard of care for stage I operable NSCLC.

Objectives:

Primary Goal: To compare overall survival at 3 years.

Secondary goals:

1. To compare disease specific survival at 3 years.
2. To compare 3 year progression free survival at the treated primary tumor site
3. To compare grade 3 and above acute and/or chronic toxicities.
4. To evaluate predictive value of pre and post treatment PET scan in clinical outcome.

Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer

International Randomized Study to Compare CyberKnife® Stereotactic Radiotherapy With Surgical Resection in Stage I Non-small Cell Lung Cancer

The study power was calculated for sample size of 420 patients, enrolled over 7 years. The actual enrollment was 36 patients over 4 years. The study was therefore terminated due to lack of enrollment. The sample size does not allow to analysis of the primary outcome.

While the study data is not mature enough to evaluate the endpoints of the study, we will attempt to describe the results gleaned from the existing patient population.

M.D. Anderson Cancer Center

Accuray Incorporated

CyberKnife Stereotactic Radiotherapy: Central lesion dose/fractionation: 15 Gy x 4 fractions = 60 Gy; Peripheral lesion dose/fractionation: 20 Gy x 3 fractions = 60 Gy

Surgery: Both open thoracotomy and video assisted thoracotomy (VATS) are acceptable procedures. Surgery may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the operative findings

Total

Age, Categorical

Age at evaluation (date of evaluation - date of birth)

Age, Continuous

Sex: Female, Male

Missing

patient's level of functioning/quality of daily life

0 - Fully active, able to carry on all pre-disease performance without restriction

1. - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
2. - Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
3. - Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
4. - Completely disabled; cannot carry on any selfcare
5. - Dead

ECOG/Zubrod performance status

T stage size/extension of tumor

T0: No evidence of primary tumor T1a: Melanoma ≤1.0 mm in thickness without ulceration and mitoses \< 1/mm 2 T1b: Melanoma ≤1.0 mm in thickness with ulceration or mitoses ≥ 1/mm 2 T2a: Melanomas 1.01-2.0 mm in thickness without ulceration T2b: Melanomas 1.01-2.0 mm in thickness with ulceration

Primary Tumour stage

Peripheral

Central

Lesion Type

study admin

At the time of study closure, 20 patients were treated on the CyberKnife arm and 16 on the Surgery arm. Two deaths were captured on the Surgery arm during the course of the study and one patient enrolled on the CyberKnife arm passed away before being treated with CyberKnife.

Overall Survival

Pts enrolled at MD Anderson

Pts enrolled from other sites

Age: 40-49

Age: 50-59

Age: 60-69

Age: 70-79

Age: 80-89

Male

Female

Central Tumor

Peripheral Tumor

While the study data is not mature enough to evaluate the endpoints of the study, we will attempt to describe the results gleaned from the existing patient population.

No patients randomized in either treatment arm made it to 3 years follow-up. No further data was collected or will be collected on the patient population.

Patient Characteristics

Overall Study

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Recurrence

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Primary Liver Cancer

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Chlorotrianisene

Liver Extracts

Transarterial Chemoembolization will be given within 12 weeks and up to 3 staged procedures, depending on the architecture of the tumor vasculature.

Transarterial Chemoembolization

Dose is 45 Gy (15 Gy in 3 fractions) or 36 Gy(12 Gy in 3 fractions). Tumors should receive the higher dose unless normal tissue constraints cannot be met.

CyberKnife SBRT

Albert Koong, MD, PhD

Daniel Chang, MD

Nishita Kothary, MD

To compare the efficacy of Transarterial Chemoembolization (TACE) to CyberKnife stereotactic body radiotherapy in the treatment of patients with locally recurrent hepatocellular carcinoma (HCC) after TACE.

Hepatocellular carcinoma (HCC) is the third most deadly cancer in the world. It is primarily seen in areas where hepatitis is endemic, such as Asia, but other risk factors include alcoholic cirrhosis.

Surgical resection and/or transplantation remain the only curative options. However, more than 80% of patients present with unresectable disease. For these patients with unresectable tumors, a variety of treatment options are available, including transarterial chemoembolization (TACE), radiofrequency ablation (RFA), radioactive microspheres, microwave coagulation, laser-induced thermotherapy, and percutaneous alcohol injection, all of which have similar survival rates. Stereotactic body radiotherapy (SBRT) for unresectable HCC is a relatively new treatment option made available because of significant improvements in diagnostic imaging and radiation delivery techniques. Although follow-up is limited, results show encouraging local control rates. Some investigators have combined TACE with fractionated conventional radiotherapy as a means of intensifying local therapy, with evidence of efficacy.

TACE remains the dominant mode of local therapy for unresectable HCC. However, recurrence rates are high. Because SBRT is rapidly becoming an accepted local therapy for hepatic lesions, its role in treating HCC needs to be further defined. Moreover, once patients have recurred after initial TACE, it is unclear if additional TACE will be as effective or if another mode of local therapy such as SBRT would be preferable.

We propose to conduct a multicenter randomized study comparing TACE vs. SBRT using CyberKnife for locally recurrent HCC. Locally recurrent HCC will include lesions that persist, progress or recur minimum 3 months after initial TACE.

Transarterial Chemoembolization (TACE) vs. CyberKnife for Recurrent Hepatocellular Carcinoma (HCC)

International Randomized Study of Transarterial Chemoembolization Versus CyberKnife® for Recurrent Hepatocellular Carcinoma

Freedom from local progression at time T is defined as lack of local progression in the treated liver lesion in the set of patients alive and on study at time T and without distant progression up to time T.

Progression-free survival will be defined as subject alive and free from local progression, disease recurrence elsewhere in the liver, extrahepatic progression, or clinical deterioration unattributable to another underlying medical condition in the absence of clear radiographic findings of progressive disease.

Overall survival will be determined as a measure of time from diagnosis of initial recurrence until death from any cause.

Serum AFP levels will be measured at specific points during the study. The 2 endpoints to be analyzed are:

* Initial AFP levels
* AFP response - the percent decrease in serum AFP levels from the initial result to the eventual nadir after therapy

These endpoints will be correlated to the clinical endpoints (freedom from local progression, progression free-survival, and overall survival).

Stanford University

Neoplasm Metastasis

Colorectal Neoplasms

Neoplasms, Second Primary

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Dose is 45 Gy (15 Gy in 3 fractions) and delivered over 5 to 10 days.

Xavier Mirabel, MD

This prospective, multicenter study is intended to establish the efficacy and toxicity of treating unresectable colorectal liver metastases with accurately administered radiation using the CyberKnife stereotactic radiosurgery system.

Colorectal cancer is the fourth most commonly diagnosed malignant disease worldwide, with an estimated 1,023,000 new cases and 529,000 deaths each year. The liver is the most frequent site of metastatic spread from colorectal cancer, 25% of colorectal cancer patients will have liver metastases at the time of initial colorectal resection and more than 50% of colorectal cancer patients will develop liver metastases during the course of the disease.

The current standard of care and only potential curative therapy for colorectal liver metastases is liver resection of the metastatic lesions. Surgical resection provides long term survival in patients with colorectal carcinoma (CRC) liver metastases. In a report of 1001 patients with metastatic colorectal cancer from Memorial Sloan-Kettering Cancer Center in NY, USA, surgical resection of liver metastases resulted in 3- and 5-year survival rates of 37% and 22%, respectively. Advances in pre- and intra-operative imaging and chemotherapy during recent years have increased overall survival up to 60% at 5 years after liver resection. However, 80-90% of liver metastases are unresectable at the time of diagnosis usually due to tumor location, multifocality, inadequate functional hepatic reserve or the patient's overall condition. For those patients, harboring unresectable liver metastases, alternative treatment approaches include neoadjuvant chemotherapy, local ablation therapy and stereotactic radiation therapy.

The recent availability of neoadjuvant chemotherapeutic agents has increased the response rates and doubled the median overall survival time for metastatic colorectal cancer from 10 to 20 months. Recent studies have demonstrated that neoadjuvant therapy allows 12.5% of patients with unresectable CRC liver metastases to be significantly downstaged and eligible for hepatic resection.

For unresectable CRC liver metastases, local ablative therapies are widely applied. Local ablative treatment refers to a variety of intervention techniques that specifically target tumors to directly destroy them. Numerous methods of ablation have been developed including cryoablation, percutaneous ethanol injection, radiofrequency ablation (RFA) and stereotactic radiation therapy. The most widely employed non-radiation based local ablative treatment is RFA which induces thermal ablation by passing high-frequency alternating current through the tumor utilizing electrodes that are placed within the tumor and surrounding tissue. RFA can be applied percutaneously under ultrasonic guidance or directly during laparoscopy or open laparotomy. Local recurrence rates of 44.4% at 18 months were reported by Solbiati et al. for CRC liver metastases with a median diameter of 2.6 cm. For tumors greater than 4 cm the local recurrence rate was 68%. RFA has an overall 3-year survival rate of 28-46% and a 5-year survival rate of 25%. However, patients with advanced hepatic decompensation, large tumors (3 to 5 cm), or multifocal tumors are generally considered poor candidates for RFA.

Conventional radiation therapy has been shown useful for palliation of hepatic capsular pain, but historically it has played a minor role in the treatment of patients with unresectable liver metastases. This can be attributed chiefly to the low tolerance of the whole liver to radiation. The liver was thought to be a relatively radiosensitive organ and with whole liver irradiation, it was difficult to achieve the radiation doses necessary to eradicate gross tumors without causing radiation induced liver disease. Partial liver irradiation has shown some promise. Limiting irradiation to only one-third of the liver through three-dimensional (3D) conformal radiotherapy techniques, including intensity modulated radiotherapy (IMRT), several studies have shown that partial liver irradiation is safe with doses up to 50-72.6 Gy. However, further dose escalation with conventional radiation therapy techniques risks injury to adjacent abdominal organs.

Stereotactic Body Radiation Therapy (SBRT) has emerged as a novel approach for the local ablation of liver metastases. SBRT provides a conformal isodose distribution with a steep radiation dose gradient allowing much higher doses of radiation than conventional radiation therapy and conformal radiotherapy techniques to be delivered safely with high precision to focal liver metastases while minimizing the radiation dose to normal liver and adjacent organs. To achieve this, precise localization of the target during treatment is required which necessitates accounting for tumor motion. SBRT technology utilizes a number of techniques to accommodate for tumor and respiratory motion including motion-restrictive techniques such as frames and abdominal compression, as well as motion-compensating techniques such as active breathing control and tumor tracking. The motion-restrictive techniques can be difficult for some patients to withstand, limiting those patients from being able to receive treatment. The motion-restrictive techniques can also necessitate the use of wide margins. Rusthoven et al. found a gross tumor volume (GTV) to planning target volume (PTV) expansion of up to 15 mm necessary in the craniocaudal direction. Wide margins can result in irradiation of a substantial volume of normal liver, potentially increasing the risk of radiation-induced injury. Some studies suggest the motion-compensating approach of active breathing control can aid in reducing the margins required by motion-restrictive approaches, however, Korreman et al. suggest those reductions may only be applicable with the use of image-guidance between and within sessions.

The CyberKnife robotic radiosurgery system (Accuray Incorporated, Sunnyvale, CA) an advanced platform to deliver SBRT, provides a therapeutic solution to this problem by continuously tracking the tumor during treatment while it accounts for organ motion due to respiratory movement, using the Synchrony respiratory tracking system (Accuray Incorporated, Sunnyvale, CA). Utilizing continuous tumor tracking, margin expansion to account for motion uncertainty can be reduced, having the potential to make this a safe and effective treatment. The frameless nature of the CyberKnife and its continuous image guidance system eliminates the need of motion-restriction techniques increasing the comfort and availability of the treatment to patients.

CyberKnife® for Hepatic Metastases From Colorectal Cancer

International, Phase II Study of CyberKnife® for Hepatic Metastases From Colorectal Cancer

Local hepatic control (non progression: complete response, partial response or stable disease) will be assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Local recurrence-free survival time is calculated as the time between the date of first treatment session and the date of the first local recurrence. Patients alive who never experienced local recurrence at the time of analysis are censored at the date of the last follow-up visit. Patients who die from causes other than local recurrence at the time of analysis are censored at the date of death.

Recurrence-free survival time is calculated as the time between the date of first treatment session and the date of a local or distant recurrence or death from progression whichever comes first. Patients alive who never experienced recurrence at the time of analysis are censored at the date of the last follow-up visit. Patients who die from causes other than cancer are censored at the date of death.

Overall survival time is calculated as the time between the date of first treatment session and the date of death, whatever the cause. Patients alive at the time of analysis are censored at the date of the last follow-up visit.

The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for toxicity assessment.

* European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) measures the quality of life for patients with cancer (for all participating sites).
* Quality of Life Questionnaire-Liver Metastases Colorectal (QLQ-LMC21) is a specific module developed by the EORTC for patients with colorectal liver metastases (for sites in the United Kingdom, The Netherlands, Germany, France, and Belgium (French speaking part)).

The PERCIST response criteria will be applied to patients who have tumor characteristics measured by a PET-Scan. The association of response according to RECIST 1.1 and PERCIST will be evaluated with Spearman's correlation coefficient and the kappa statistic.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer	NCT00840749	Non-small Cell ...	CyberKnife Ster... Surgery	18 Years -	Accuray Incorporated
Transarterial Chemoembolization (TACE) vs. CyberKnife for Recurrent Hepatocellular Carcinoma (HCC)	NCT01318200	Recurrent Hepat...	Transarterial C... CyberKnife SBRT	18 Years -	Accuray Incorporated
Randomized Study to Compare CyberKnife to Surgical Resection In Stage I Non-small Cell Lung Cancer	NCT00840749	Non-small Cell ...	CyberKnife Ster... Surgery	18 Years -	Accuray Incorporated
CyberKnife® for Hepatic Metastases From Colorectal Cancer	NCT01318447	Colorectal Live...	CyberKnife SBRT	18 Years -	Accuray Incorporated

Spots Global Cancer Trial Database for accuray

Every month we try and update this database with for accuray cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for accuray

Every month we try and update this database with for accuray cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for accuray cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.