Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Rare Diseases

Sarcoma

Sarcoma, Ewing

Rhabdomyosarcoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Myosarcoma

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Soft Tissue Sarcoma

Ewing Sarcoma

Neuroepithelioma

Eligible patients will be accessioned at the time of irradiation and undergo a pre-radiotherapy evaluation, treatment planning, image-guided radiotherapy delivery and intra-and post-irradiation evaluations.

Conformal limited image radiotherapy is radiation therapy that targets tumors with a prescribed dose of radiation which allows the surrounding normal tissues to remain basically untreated.

image-guided radiotherapy

Matthew Krasin, MD

Researchers at St. Jude Children's Research Hospital are looking for more effective ways to deliver radiation therapy to pediatric tumors of the bone and soft tissues. The goal of the study is to improve local control of musculoskeletal tumors with image-guided radiation therapy (IGRT) while minimizing radiation related side effects. IGRT uses computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) images to precisely define tumor location and to carefully plan radiation treatment. This approach allows doctors to deliver highly conformal radiation therapy to the tumor while protecting nearby healthy normal tissues.

The study focuses on the following primary Objectives:

* To estimate local control rates with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST).

  * Prospectively establish a baseline estimate of local control for patients with MST (Ewing's sarcoma family of tumors (ESFT), rhabdomyosarcoma (RMS) and non-rhabdomyosarcoma soft tissue sarcoma (STS)) treated with image guided radiation therapy.
  * Demonstrate that the increased level of conformality afforded by image guided radiation therapy does not reduce its efficacy relative to previously utilized non-image guided radiation therapy techniques in patients with Ewing's sarcoma family of tumors, resected soft tissue sarcomas, and group III rhabdomyosarcomas.
  * Assess local and regional patterns of failure for patients with MST treated with image guided radiation therapy relative to their targeted volumes.
  * Provide a long term (\>5 year) estimate of local disease control for patients with MST (Ewing's sarcoma family of tumors (ESFT)), rhabdomyosarcoma (RMS), and non-rhabdomyosarcoma soft tissue sarcoma (STS) treated with image guided radiation therapy.

The study focuses on the following secondary objectives:

* Establish a quantitative baseline estimate of radiation dose-related changes in normal tissues using novel objective measures of somatic change, musculoskeletal function, tissue biochemistry and physiology.

  o Investigate the dose and volume relationship for the developing physis and cortical bone using physical measures and imaging evaluations including:
  * Prospectively investigate whether an age based radiotherapeutic threshold of dose and volume that will induce premature physis closure and alter long bone length can be quantitatively identified.
  * Quantitatively explore the impact of radiation on cortical bone thinning and long bone curvature.
  * Relate radiation dose and volume to late (10+ year) alterations in bone integrity.
* Describe the severity and time course of radiation-induced changes in the soft tissues including muscle.

  * Delineate sequential changes in muscular volume, muscle function and organ function (delineated by imaging and measures of physical function) following image guided radiation for specific muscular groups.
  * Correlate the temporal changes in muscular volume and function with changes in vascularity and metabolism defined by imaging studies.

Radiation Therapy to Treat Musculoskeletal Tumors

Image Guided Radiotherapy for the Treatment of Musculoskeletal Tumors: A Phase II Prospective Evaluation of Radiation-related Treatment Effects

To estimate local control rates with image guided radiation therapy as defined in this study for patients with primary musculoskeletal tumors (MST).

Investigate the dose and volume relationship for the developing physis and cortical bone using physical measures and imaging evaluations.

Investigate the dose and volume relationship for the develop8ing physis and cortical bone using physical measures and imaging evaluations.

Describe the severity and time course of radiation-induced changes in the soft tissues and adjacent organs, including muscle and subcutaneous tissues.

Lance Armstrong Foundation

St. Jude Children's Research Hospital

all patients undergoing surgery for musculoskeletal tumors

Yuriy Gubenko, MD

This study is being done as the doctor investigators would like to lessen the amount of blood transfusions given to patients. Patients who receive blood transfusions have a greater chance of developing complications after surgery. There is a device called the Cell Saver that allows the doctors to process blood that is lost during surgery and return it to the patient. This lessens the amount of transfused blood the patients receive. This device is not used for patients undergoing surgery for muscular skeletal tumors.The investigators are not sure whether tumor cells are present in the blood which is lost during the course of an operation like yours. The goal of this study is to see if we lessen the amount of blood transfusions given to patients who may have tumor or cancerous cells present in their blood. One way to do this is to test the blood that is circulating in your veins and also to test the blood which is lost during the course of your operation

Allogenic Blood transfusions are associated with numerous complications from simple uticaria to serious transmissible diseases. While improved testing has significantly decreased the incidence of AIDS and hepatitis C to approximately 1:2,000,000 units tested; hepatitis B approximately 1:200,000 units tested, more frequent complications occur secondary to immunomodulation, which results in making infections more common. These are not due to infected blood, but develop because of changes in patients' immune system after having received an allogenic red blood cell transfusion. The relative risk for developing an infection is 1.6 for 1-3 red blood cell units and 3.6 for patients who receive more than 3 red cell units. Patients who receive transfusions have a 52% greater risk of developing pneumonia and a 35% greater risk of developing a urinary tract infection. On average, hospitalization costs $14,000 more for patients with a serious infection. These infections prolong the length of hospitalization after surgery and may even result in death.2 Other complications of transfusion include Transfusion Related Acute Lung Injury which causes at least 5300 TRALI reactions per year in the US alone, and approximately 500 deaths. In fact, just one donor whose blood triggered a TRALI death was found on review of records to have caused 14 previous cases of TRALI. Other serious complications include Adult Respiratory Distress Syndrome, and transfusion reactions. As a group, these complications of transfusion result in increased morbidity and mortality. Therefore, it is in the best interest of patients to decrease the amount of allogenic blood transfused (from other individuals). To prevent this, surgeons employ the use of a Cell Saver (CS) during surgery which collects the patient's own blood from the operative field and washes it. This blood is then re-infused into the patient's intravenous, minimizing the need for transfusion of blood from the blood bank.

Despite the benefits of the cell saver, it is not used in patients who have malignancy due to concern that the tumor cells may spread systemically via the blood. Due to the nature of musculoskeletal tumor resections there is often significant blood loss. Dissection is regularly through the muscles rather than around muscular intervals, which can result in significant bleeding. The goal of this study is to determine the presence or absence of tumor cells in the blood suctioned from the surgical field. Pending the outcome, consideration will be made to go forward with a second study to determine if cell saver could be used in patients with malignancy undergoing surgery.

It is unclear whether tumor cells are present in the blood suctioned from an extremity malignancy resection. It is also unknown if the processing of blood suctioned would remove tumor cells from the blood to be transfused. If no tumor cells are found in the blood after processing then transfusion of this blood would likely be safe. This could result in decreased blood transfusions in this patient population. This would not only decrease risk to these patients, it would also improve the blood supply, ensuring that blood is available for other patients who require it. This work is highly significant as it would both improve safety in this patient population and improve the blood supply. Data collected will include the patient's diagnosis, the presence or absence of metastatic disease, whether they have been previously treated with chemotherapy or radiation and the dates of that treatment. Patients will undergo surgery and anesthesia in the usual manner. Three sets of specimens approximately 4mL each would be taken; one from a peripheral line prior to opening the skin, the second sample will be taken from the surgical field or suction canister during the tumor resection the third from the surgical field or suction canister shortly before the tumor is removed. These samples will be taken to Dr. Fitzhugh's laboratory for slide staining.

Patients who are determined by their surgeon and/or anesthesiologist to require blood will be administered blood processed by the University Hospital Blood Bank using standard transfusion protocols. No blood taken from the patient or the operative field will be transfused.

There are no significant risks in this study. Roughly 2 ml of blood is required for the total number of slides (2-4) that would be prepared per tube. This amount of blood 12 mL is less than one tablespoon and does not pose significant risk to the patient nor does it increase the likelihood of transfusion. Slides will be stained using the Diff-Quik staining method, a method similar to the Wright-Giemsa staining used in hematology laboratories. The technique is rapid (requires only 3 minutes per submitted sample) and inexpensive. Slides will be reviewed by Dr. Fitzhugh.

Analysis of Blood During Surgery for Musculoskeletal Tumors

Cellular Analysis of Blood Suctioned During Surgery for Musculoskeletal Tumors

specimens taken twice from operative field; once just prior to removal of tumor and the second just after tumor removal.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radiation Therapy to Treat Musculoskeletal Tumors	NCT00186992	Sarcoma, Ewing'... Rhabdomyosarcom... Soft Tissue Sar... Musculoskeletal...	image-guided ra...	- 25 Years	St. Jude Children's Research Hospital
Radiation Therapy to Treat Musculoskeletal Tumors	NCT00186992	Sarcoma, Ewing'... Rhabdomyosarcom... Soft Tissue Sar... Musculoskeletal...	image-guided ra...	- 25 Years	St. Jude Children's Research Hospital
Analysis of Blood During Surgery for Musculoskeletal Tumors	NCT01682252	Musculoskeletal...		18 Years - 90 Years	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for musculoskeletal tumors