Antineoplastic Agents

All Drugs and Chemicals

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Eligible patients (not candidates for curative treatment) will have measurable lesions in the anatomic thorax, abdomen or pelvis (any histology) amenable to palliative radiation treatment (30 Gy in 10 fractions). Patients receive sorafenib orally for one week prior to radiation, then concomitantly for two weeks with radiation and then for one week following completion of radiation. Each anatomic cohort will dose escalate independently. If full oral dose (400 mg po bid) is reached in a given cohort (dose level three) then an additional dose level will open where sorafenib treatment (400 mg bid) is extended following radiation for a total of eight weeks.

Sorafenib orally for one week prior to radiation, then concomitantly for two weeks with radiation and then for one week following completion of radiation. Each anatomic cohort will dose escalate independently. Dose level 1 is 200mg of sorafenib. If full oral dose (400mg orally, twice a day) is reached in a given cohort then an additional dose level will open where sorafenib treatment is extended following radiation for a total of eight weeks.

Anthony Brade

The purpose of this study is to test the combination of radiation treatment and an anti-angiogenic drug called sorafenib (or BAY 43-9006 or Nexavar) to determine the effects of this combination on cancers but also on side effects of radiation treatment. This study will also determine the highest safe dose of sorafenib that can be given with radiation treatment.

A Study of Radiation With Sorafenib in Advanced Cancer

A Phase I Dose Escalation Study of Concurrent Low Dose Radiation With Sorafenib in Three Anatomically-based Independent Cohorts (Thorax, Abdomen, Pelvis)

To measure safety and maximum tolerated dose, all adverse events will be assessed in line with dose limiting toxicities.

To assess the efficacy of adding sorafenib to radiation treatment, radiological imaging will be used to assess response rate inline with the RECIST criteria.

University Health Network, Toronto

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

All Conditions

Symptoms and General Pathology

Rare Diseases

Wilms Tumor

Neoplasms by Histologic Type

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Syndrome

Neoplastic Syndromes, Hereditary

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Genetic Diseases, Inborn

Wilms' Tumor

Favorable Histology Stage I \& II and FH Stage III/IV Delayed Local Control with clear surgical margins and pathologically negative lymph nodes. Participants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy.

Participants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT.

Participants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT

The treatment approach with radiation therapy prescribed in this trial is designed to deliver highly conformal radiation therapy (proton beam radiation or intensity modulated photon radiation) to target volumes that are based on the burden of disease.

Proton Beam Radiation (PBRT)

Patients will receive standard of care chemotherapy based on diagnosis and stage.

DD-4A Chemotherapy Regimen

Participants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy

Complete Surgical Resection

Participants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy.

Surgical Resection

Participants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy.

Partial Nephrectomy

Matthew J Krasin, MD

Participants are being asked to take part in this clinical trial, a type of research study, because the participants have a Wilms Tumor cancer.

Primary Objectives

To determine whether delivery of proton beam radiation to a conformal reduced target volume in the flank allows normal flank growth compared to the contralateral untreated side and non-irradiated patients.

Secondary Objectives

To deliver proton beam radiation to a conformal reduced target volume (partial kidney proton beam radiation therapy) in the affected kidney(s) for patients with Stage V (bilateral Wilms tumor) and specific involved surgical margins yielding no reduction in the high control rates seen with more traditional flank / whole kidney fields.

Exploratory Objectives

* Study the feasibility of sparing the residual kidney, spine and liver in patients requiring whole abdomen radiation therapy using either a proton beam treatment technique or intensity-modulated radiation therapy ( IMRT) photon based technique.
* Study the feasibility of delivering whole lung radiation therapy with proton beams with the goals of sparing the developing breast tissue, heart structures, thyroid and liver.
* Develop simultaneous xenografts and organoid models from the same starting material to study Wilms tumor biology and compare responses to chemotherapeutic agents.
* Define the evolution of organ specific (kidney, liver, pancreas, etc.) abnormalities (laboratory studies) as an early marker of possible late end organ damage and their relationship to radiation.
* Study and evaluate impact of proton therapy on the musculoskeletal system and physical performance and compare with photon therapy cases treated with classical treatment fields.
* Assess CTC-AE and Pediatric Patient Reported Outcomes during radiation and in follow-up, correlating with disease, treatment and patient variables.
* Correlate quantitative MRI values, including apparent diffusion coefficient (ADC) values, with histopathology findings post-surgery in children with (bilateral) Wilms.
* Assess daily variations in proton range along each treatment beam using standard pre-treatment cone beam CT or on-treatment MR.

Participants will receive proton beam radiation therapy (PBRT) according to stage and surgical findings.

Favorable Histology Stage I \& II and FH Stage III/IV Delayed Local Control with clear surgical margins and pathologically negative lymph nodes: Participants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy. PBRT will not be administered to the primary site in those with no evidence of spill, peritoneal involvement, lymph node (LN) involvement or microscopic residual in the abdomen. Systemic therapy will be delivered in a standard of care manner according to histology and stage.

Stage III \& IV Adjuvant RT: Participants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT. Systemic therapy will be delivered in a standard of care manner according to histology and stage.

Stage V Adjuvant RT: Participants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy. Those with evidence of LN involvement, surgical margin involvement, local or diffuse spill, gross disease in the renal bed or peritoneal implants, will receive adjuvant PBRT. Systemic therapy will be delivered in a standard of care manner according to histology and stage.

Systemic therapy will follow a well-defined standard of care based on Children's Oncology Group (COG) approaches including pre-operative chemotherapy and adjuvant chemotherapy. The intent will be to standardize chemotherapy to ensure a consistent background of standard of care therapy, while not mandating additional data collection beyond the specific trial objectives.

Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation

Multi-Center Trial Sponsored by St. Jude Children's Research Hospital for the Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

Half circumference measurement at 3 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation

Half circumference measurement at 5 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation

Half circumference measurement at 7 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation

Half circumference measurement at 10 year from irradiated and unirradiated hemi-abdomen for patients in need of flank radiation

This objective is to investigate whether deliver proton beam radiation to a conformal reduced target volume (partial kidney proton beam radiation therapy) in the affected kidney(s) for patients Stage V (bilateral Wilms tumor) with specific involved surgical margins yielding no reduction in the high control rates seen with more traditional flank / whole kidney fields.

St. Jude Children's Research Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Heart and Blood Diseases

Hemorrhage

Urolithiasis

Lung Neoplasms

Necrosis

Pain

Urinary Calculi

Flank Pain

Intracranial Hemorrhages

Calculi

Pathological Conditions, Anatomical

Neurologic Manifestations

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Vascular Diseases

Hematinics

Liver Extracts

CNS: Known or suspected pathology in the posterior fossa

Thorax: Patients referred for staging of a known or suspected lung cancer

Abdomen: Patients with acute flank pain and suspected urolithiasis

Abdomen: Patients with a known or suspected focal liver lesion

This study is being performed to confirm that the new technique, Model-Based Iterative Reconstruction (MBIR) with reduced radiation dose can deliver equivalent image quality for CT scans compared to current techniques (Filtered Back Projection with Adaptive Statistical Iterative Reconstruction (FBP with ASiR) and also to demonstrate that MBIR can improve general image quality characteristics at equivalent radiation dose levels.

Pilot Study of Model Based Iterative Reconstruction Using 64-Slice

Pilot Study of Model Based Iterative Reconstruction Using 64-Slice Multidetector-Row CT Datasets Obtained From the Central Nervous System, Thorax, and Abdomen

Ultra-low radiation dose images reconstructed with MBIR yield similar anatomic and pathologic information compared to routine radiation dose images reconstructed with Filtered Back Projection (FBP) in the central nervous system (CNS), thorax, and abdomen.

American College of Radiology - Image Metrix

GE Healthcare

Infections

Abscess

Patients treated by percutaneous CT-guided procedures in the abdomen with the EPIONE® device

The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.

EPIONE® CT-Guided Percutaneous procedures

THIERRY DE BAERE, MD

Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen

The objective of this PMCF study is to compile data on the routine use of the EPIONE® device in subjects undergoing CT-guided percutaneous procedures in the abdomen.

The objectives are:

1. to evaluate the technical success of the device
2. to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence, operator satisfaction) and the safety of the device

55 patients are planned in this post-market study.

Epione® Post-Market Clinical Follow-up Study

Post-Market Clinical Follow-Up Study of a Robotic Device for Image Guided Percutaneous Needle Placement in the Abdomen

Number of targets reached ; the target is considered to have been reached when the needle is positioned accurately enough to allow the planned procedure to be performed.

accuracy of the needle placement: deviation between the planned and actual needle position once inserted

Detail of the number/nature of adjustments performed after the initial insertion of the needle

Minimal Ablation Margin(s) measure(s) if applicable (mm)

Evaluation of the local tumor progression following the ablation (if applicable)

5-point Likert scale: very Dissatisfied/dissatisfied/neutral/satisfied/highly satisfied

Quantum Surgical

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Wounds and Injuries

Communicable Diseases

Intestinal Diseases

Aneurysm

Kidney Calculi

Nephrolithiasis

Leiomyoma

Aortic Aneurysm

Gastrointestinal Diseases

Myofibroma

Diverticulitis

Pregnancy, Ectopic

Pancreatitis

Intraabdominal Infections

Gallstones

Cholelithiasis

Cholecystolithiasis

Cysts

Ovarian Cysts

Polyps

Appendicitis

Cardiac Complexes, Premature

Abdominal Injuries

Pancreatic Diseases

Aortic Diseases

Gastroenteritis

Cecal Diseases

Neoplasms, Connective and Soft Tissue

Diverticulum

Diverticular Diseases

Biliary Tract Diseases

Gallbladder Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Gonadal Disorders

Endocrine System Diseases

Subjects that present to the Emergency Department with complaints necessitating abdominal or pelvic imaging.

Duke employees that will voluntarily have an abdominal or pelvic ultrasound for with the sole purpose being for the study.

Joshua Broder, MD

Summary

1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen and/or pelvis.
2. Study activities and population group. The study population will be a convenience sample of patients of any age presenting to the Emergency Department with complaints necessitating a clinical abdominal and/or pelvic imaging. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. 3.Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality.

This study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. The investigators are not measuring the effect of the ultrasound examination on the subjects' outcomes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Radiation With Sorafenib in Advanced Cancer	NCT00610246	Cancer	Sorafenib	18 Years -	University Health Network, Toronto
Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation	NCT04968990	Wilms Tumor	Proton Beam Rad... DD-4A Chemother... Complete Surgic... Surgical Resect... Partial Nephrec...	-	St. Jude Children's Research Hospital
Pilot Study of Model Based Iterative Reconstruction Using 64-Slice	NCT01431378	Posterior Fossa... Lung Cancer Flank Pain Urolithiasis Focal Hepatic N...		30 Years -	GE Healthcare
Treatment of Newly Diagnosed Patient's With Wilm's Tumor Requiring Abdominal Radiation Delivered With Proton Beam Irradiation	NCT04968990	Wilms Tumor	Proton Beam Rad... DD-4A Chemother... Complete Surgic... Surgical Resect... Partial Nephrec...	-	St. Jude Children's Research Hospital
A Study of Radiation With Sorafenib in Advanced Cancer	NCT00610246	Cancer	Sorafenib	18 Years -	University Health Network, Toronto
A Study of Radiation With Sorafenib in Advanced Cancer	NCT00610246	Cancer	Sorafenib	18 Years -	University Health Network, Toronto
Epione® Post-Market Clinical Follow-up Study	NCT05529979	Cancer Abdomen	EPIONE® CT-Guid...	18 Years -	Quantum Surgical
Point of Care 3D Ultrasound for Various Applications: A Pilot Study	NCT02831556	Appendicitis Evidence of Cho... Gallstones Pregnancy, Ecto... Aortic Aneurysm Kidney Stones Intrauterine Pr... Diverticulitis Abdominal Injur... Tumors Pancreatitis Digestive Syste... Gastrointestina... Intraabdominal ... Intestinal Dise... Pregnancy Vascular Diseas... Uterine Fibroid... Ovarian Cysts Uterine Abnomin... Bladder Abnomin... Testicular Abno... Polyps		-	Duke University

Spots Global Cancer Trial Database for abdomen

Every month we try and update this database with for abdomen 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 abdomen

Every month we try and update this database with for abdomen 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 abdomen 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.