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

Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Blood and Lymph Conditions

Neoplasm Metastasis

Pain

Bone Neoplasms

Bone Marrow Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

A dose of 8 Gy delivered in a single fraction will be prescribed to the PTV, delivered with FLASH Radiotherapy (\>40 Gy/s).

FLASH Radiotherapy

Jennifer Woo

Stefanie Parker

Cincinnati Children's Hospital Medical Center-Cancer Line

John Breneman, MD

Emily Daugherty, MD

John Perentesis, MD

The purpose of this study is to assess toxicities of FLASH radiotherapy treatment and pain relief in subjects with painful thoracic bone metastases. FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.

This clinical investigation is designed to assess the toxicities of FLASH radiotherapy treatment, as well as pain relief when used to treat bone metastasis(-es) in the thorax. Workflow metrics of FLASH radiotherapy in the thorax in a clinical setting will also be assessed. Patients at least 18 years of age with painful bone metastases located in the thorax will be considered for the study. Eligible subjects will be treated for painful bone metastases in the thorax using a palliative regimen of FLASH radiotherapy and followed post-treatment until subject death or lost to follow-up.

FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax

Toxicities that are possibly, probably, or definitely related to FLASH radiotherapy. Toxicities will be classified per CTCAE version 5.0.

Capture dose and frequency of pain medication usage or pain medication changes.

Treatment for an individual subject will be deemed NOT feasible if delays in study treatment of more than 10 business days from simulation to treatment occurs related to the investigational device (excluding delays due to patient or facility factors not related to study treatment).

Varian, a Siemens Healthineers Company

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Heart and Blood Diseases

Hemorrhage

Urolithiasis

Lung Neoplasms

Necrosis

Urinary Calculi

Flank Pain

Intracranial Hemorrhages

Calculi

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

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

Head and Neck Neoplasms

Thoracic Neoplasms

Nervous System Neoplasms

Pelvic Neoplasms

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

The use of the FDA approved drug sunitinib, used in an "off-label" manner with external beam radiation therapy.

Radiotherapy will be administered Monday through Friday for a maximum of 8 weeks. Total dose will depend on the patient's disease site.

External Beam Radiation Therapy

Adam P Dicker, MD, PhD

This study is using the combination of radiation and antiangiogenic agents (agents that destroy existing blood vessels) seems to be an approach to tumor cure.

The combination of ionizing radiation and antiangiogenic agents seems to be a counterintuitive approach to tumor cure because oxygen is a potent radiosensitizer and a reduction in oxygen concentration would be expected following a reduction in tumor vasculature after antiangiogenic treatment.

Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients

A Phase IB, Open-Label, Safety Study of the Combination of Sunitinib and Radiation for the Treatment of Patients With Cancer

The purpose of this study is to determine the safety of the combination of the antiangiogenic, sunitinib, when combined with external beam radiotherapy.

Urine VEGF may be a biomarker of response. This translational approach may be useful to determine who benefits from treatment.

Pfizer

Sidney Kimmel Cancer Center at Thomas Jefferson University

Rare Diseases

Carcinoma

Small Cell Lung Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

3D conformal thoracic radiotherapy at a total dose of 45 Gy in 30 fractions, 2 fractions per day, 5 days a week

3D conformal thoracic radiotherapy at a total dose of 60 Gy in 40 fractions, 2 fractions per day, 5 days a week

45 Gy in 30 fractions

3D conformal thoracic radiotherapy at a total dose of 60 Gy in 40 fractions, 2 fractions per day, 5 days a week. If doses to organs at risk exceed normal tissue tolerance, the dose may be lowered to a minimum of 54 Gy.

60 Gy in 40 fractions

Bjørn H Grønberg, md phd

The majority of patients with limited disease small cell lung cancer (SCLC) experience recurrent disease despite receiving concurrent chemoradiotherapy. New agents and dose-escalation of chemotherapy have not provided a survival benefit. Local failure accounts for high proportion of recurrences. Improved thoracic radiotherapy (TRT) might increase local control and thus reduce the recurrence rate and prolong survival. Positron emission tomography (PET CT) is better for staging of SCLC than computer tomography (CT) and bone scan. More precise localization of tumors leads to more accurate definition of target volumes for TRT and reduce the radiation dose to normal tissue. A large proportion of patients relapse and die within one and two year after therapy. Few patients survive longer than three years. Thus, two-year survival is considered a clinically highly relevant measure of efficacy.

The aim of this study is to compare two schedules of TRT with respect to local control, progression free survival, overall survival, toxicity and health-related quality of life. In addition patients who have the best outcomes and tolerate chemoradiotherapy will be characterized (e.g. clinical characteristics, blood biomarkers, body composition).

Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer

A Randomized Phase II Study Comparing Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer

All patients will be included in these analyses. Blood will be collected, the study group will define which markers to analyze when all patients have been enrolled.

measured for all patients from the date of the first day of the first course of chemotherapy until the date of death from any cause (or last contact/observation if lost to follow-up - or the follow-up is completed before all patients die).

measured for all patients from the date of the first day of the first course of PE to the first date of objective progression (according to RECIST 1.1) of disease or of death from any cause. For each patient who has not died or has non-progression at the cut-off date for the analysis, PFS will be censored at the date of the patient's last tumor assessment prior to the cut-off date. Statistical survival analyses will be done with Kaplan Meier. Log rank test will be used for comparing groups.

Proportion of all patients who experience disease recurrence within radiotherapy fields assessed by comparing dose plans and follow-up CT scans.

assessed for all patients receiving at least one course of chemotherapy from reported blood values and adverse event. Classified and graded according to CTCAE 4.0. Compared using Pearson's Chi-square and Fischer's exact tests.

assessed from completed questionnaires. Patients will report HRQoL on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and the lung cancer specific module LC13. The QLQ-C30 measures fundamental aspects of HRQoL and symptoms commonly reported by cancer patients in general, the LC13 measures symptoms commonly associated with lung cancer and its treatment.

All HRQoL scores will be transformed to a scale from 0 to 100 according to the EORTC scoring manual. A difference in mean scores of \>10 is considered clinically relevant. For group comparisons of baseline scores during and after chemotherapy, and changes in scores from baseline, the Mann-Whitney test will be used. Primary HRQoL-endpoints are dysphagia and dyspnea.

St. Olavs Hospital

Oslo University Hospital

University Hospital of North Norway

Sorlandet Hospital HF

Norwegian University of Science and Technology

Digestive System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Patients with cancer of the head and neck, thorax and upper gastrointestinal tract, who are receiving or may receive treatments known or hypothesized to have an immunomodulatory antitumor effect.

Collection of tumor, blood, lymph nodes, white blood cells, mouth cells (buccal smears) scraped from the inside of your cheek, urine, saliva, or other tissue samples.

Collection of biological specimens

Patrick Forde, MD

Peggy Fitzpatrick, RN

This research is being done to collect and store biological specimens (biospecimens) from people with cancer, regardless of tumor type, who are receiving treatments known or thought to have an effect on the immune system.

The goal of this discovery and exploratory study is to:

* Understand changes in the immune system associated with various cancer treatments, in order to better design new therapies or tests to predict how these treatments might work.
* Identify risk factors for those who go on to develop side effects from immunotherapy.

Participants may be asked to:

* Donate samples of tumor, blood, lymph nodes, white blood cells, mouth cells (buccal smears) scraped from the inside of participant's cheek, urine, saliva, or other tissue samples.
* Complete questionnaires about immunotherapy side effects at baseline and with follow-up appointments.
* Undergo knee x-rays.
* Allow the use of demographic and clinical information.

The Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies Protocol is a discovery and exploratory protocol that will enable the investigators to obtain and archive biological specimens from patients with cancer of the head and neck, thorax and upper gastrointestinal tract, who are receiving or may receive treatments known or hypothesized to have an immunomodulatory antitumor effect. The investigators aim to conduct immunologic studies across tumor types and treatment modalities in order to accomplish the following:

1. Gain mechanistic insights into the potential influence of various forms of cancer therapy on antitumor immunity, including but not limited to chemotherapies, kinase inhibitors, angiogenesis inhibitors, immune-modulating monoclonal antibodies, cellular immune therapies and radiation therapy.
2. Define new tumor antigens and the tumor antigens' relevance to disease biology, and correlate antigen expression with immune responses and disease outcomes.
3. Evaluate potential immune-related prognostic or treatment response indicators.
4. Assess the immunologic features of pre-malignant lesions (e.g., atypical or dysplastic nevi, dysplastic bronchial epithelium, colonic adenomas), and compare these features to features of invasive cancers.
5. Investigate the immunobiology of neoadjuvant and adjuvant cancer therapies, including but not limited to cancer vaccines.
6. Develop protein-, RNA-, and DNA-based blood markers to monitor tumor burden and predict and detect tumor relapse.
7. Evaluate the causative mechanisms of immune-related toxicities in patients receiving cancer therapy with immune checkpoint blockade.
8. Characterize factors and molecular pathways in the tumor immune microenvironment that lead to immune suppression, tolerance to tumor antigens, and cancer progression.
9. Understand the epidemiology of and risk factors for particular immune related adverse events (irAEs) including inflammatory arthritis, sicca syndrome and myositis

To support the above research aims, biological specimens obtained and processed in the individual laboratories of the co-investigators will be linked by a centralized demographic database, allowing for the retrieval of information regarding specimen characteristics (e.g., tumor type, treatment exposure, date of specimen retrieval, anatomic site of biopsy, biopsy procedure) and clinical outcomes. Participants starting on immune checkpoint inhibitors will complete a survey when the participants enroll on study to assess for potential risk factors for irAE development. Participants will also undergo knee radiographs to evaluate for osteoarthritis, baseline survey for personal and family historical risk factors, and serial surveys designed to screen for development of irAEs This information will be correlated with the results of exploratory scientific analyses conducted in the laboratories of the co-investigators. Hypotheses generated from this work are expected to support future hypothesis-driven scientific investigations and clinical trial development.

* Tissue Sample Acquisition:

  * Excess material collected in the course of therapeutic procedures that are clinically indicated; or
  * New biopsies performed for research purposes (e.g., a palpable subcutaneous nodule, or a lymph node that is accessible by ultrasound or computed tomography scan guidance under local anesthesia).
* Blood Sample Acquisition: A peripheral blood sample will be collected from each participating subject for the isolation and cryopreservation of viable peripheral blood mononuclear cells, serum, and plasma.
* Leukapheresis: patients may undergo pheresis for the purpose of collecting large numbers of leukocytes for research purposes.
* Buccal smears
* Bronchoscopy: Endobronchial brushings +/- biopsies
* Nasal Epithelium Collection
* Expectorated Sputum Collection

Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies

This is a clinic based registry of cancer therapy data from participants to be collected over time.

This is a virtual tissue bank containing biological specimens from participants collected over time.

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
FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax	NCT05524064	Bone Metastases...	FLASH Radiother...	18 Years -	Varian, a Siemens Healthineers Company
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
Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients	NCT00437372	Cancer Head and Neck C... Pelvic Cancer Nervous System ... Thoracic Neopla...	Sunitinib External Beam R...	18 Years -	Thomas Jefferson University
Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer	NCT02041845	Small Cell Lung...	45 Gy in 30 fra... 60 Gy in 40 fra...	18 Years -	Norwegian University of Science and Technology
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
Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients	NCT00437372	Cancer Head and Neck C... Pelvic Cancer Nervous System ... Thoracic Neopla...	Sunitinib External Beam R...	18 Years -	Thomas Jefferson University
Phase IB Study Using Sunitinib Plus Radiation Therapy for Cancer Patients	NCT00437372	Cancer Head and Neck C... Pelvic Cancer Nervous System ... Thoracic Neopla...	Sunitinib External Beam R...	18 Years -	Thomas Jefferson University
Immunobiology Blood and Tissue Collection of Upper Aerodigestive Malignancies	NCT05995821	Head and Neck C... Lung Cancer Gastrointestina...	Collection of b...	18 Years -	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Spots Global Cancer Trial Database for thorax

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

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