Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Amino Acids

Gemcitabine

Capecitabine

Cisplatin

Pancrelipase

Erlotinib Hydrochloride

Pancreatin

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Dose-escalation phase I clinical study. In the initial dose levels, 'dose-escalation' refers to an increase in the radiotherapy dose delivered using carbon ion radiotherapy along with a corresponding decrease in the dose delivered using photons.

Study subjects will receive carbon ion radiotherapy (CIRT), with daily fraction sizes of 3 GyE. The total CIRT dose will increase with each dose level. Subjects in dose level 1 and 2 will receive photon radiotherapy as well.

Carbon Ion

Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen.

All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy.

Gemcitabine + Cisplatin

Gemcitabine + Capecitabine

Gemcitabine + Erlotinib

During this study, the prescribed dose shall be administered according to the dose escalation shown in the table, starting with dose level 1. The carbon ion dose shall be gradually escalated while gradually reducing the dose of photons until eventually administering a full dose of 56 GyE/14 Fx carbon ions (fractional dose of 4 GyE). Dose escalation will be performed in parallel for two patient groups: patients whose pancreatic tumors are greater than 5 mm from the duodenum (Group A) and those whose tumors are within 5 mm of the duodenum (Group B). Enrolled patients will be monitored for 90 days after radiotherapy starts for any acute toxic reaction and to explore the maximum tolerated dose, in addition to being observed for any related long-term toxic reactions in accordance with the protocol.

Photon

Chandan Guha, M.B.B.S., Ph.D.

This is a phase I trial to determine the maximum tolerated dose of carbon ion radiotherapy for the treatment of locally advanced, unresectable, pancreatic cancer.

Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer

A Prospective Phase I Clinical Trial of Carbon Ion Radiation Therapy for Locally Advanced, Unresectable Pancreatic Cancer

Any CTCAE v. 4.03 non-hematologic adverse event of grade 3 or higher or any hematologic adverse event of grade 4 or higher, occurring within 90 days of the start of radiotherapy and deemed to be related to carbon ion radiotherapy.

Any grade 2 or higher treatment-related toxicity, scored using CTCAE v. 4.0

Radiographic changes following completion of study therapy (RECIST v. 1.1)

The length of time from study inclusion until death from any cause

The length of time from study inclusion until death from any cause or disease progression at any site

Quality of life will be assessed at various time points using the European Organisation for Research and Treatment of Cancer 30 items dealing with fatigue, pain, nausea and vomiting, general condition and social, emotional and cognitive functions. It is currently used in many cancer related clinical trials.

Shanghai Proton and Heavy Ion Center

Albert Einstein College of Medicine

Associate Professor

Skin and Connective Tissue Diseases

Breast Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Melanoma

Head and Neck Neoplasms

Carcinoma, Basal Cell

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Skin Diseases

Breast Diseases

Neoplasms, Squamous Cell

Neoplasms, Basal Cell

Central Nervous System Depressants

Anesthetics

Immunomodulating Agents

Anesthetics, Local

Charcoal

Antidotes

Protective Agents

Intraoral squamous cell carcinomas that are resected and receive adjuvant radiation therapy. These patients may receive a Carlo Erba Ink injection before surgical tumor resection, after tumor resection (in the postsurgical radiation field), or in both instances. Patients whose tumor is within 5 mm of the surface will have injections of India ink into the tumor itself and measurements made in the tumor prior to surgery. Patients whose tumor is deeper than 5 mm of the surface could participate only in the measurements of the postsurgical radiation field. EPR Oximetry measurements will be made in the tumor and/or, if applicable, over the course of radiation in the postsurgical radiation field as appropriate.

Patients with primary cutaneous malignant tumors (including but not limited to squamous cell carcinoma, basal cell carcinoma, or melanoma) whose tumor is within 5 mm of the surface and whose treatment plan includes surgical resection and/or postsurgical radiation therapy. These patients may receive a Carlo Erba Ink injection before surgical tumor resection, after tumor resection (in the postsurgical radiation field), in both the tumor and the postsurgical radiation field, or in the tumor prior to radiation therapy. EPR Oximetry measurements will be made in the tumor and/or, if applicable, over the course of radiation in the tumor or postsurgical radiation field as appropriate.

Breast cancer patients whose treatment plan includes surgical resection followed by radiation therapy. All patients who receive a surgical resection will receive a Carlo Erba Ink injection in the radiation field after sufficient healing has occurred to the area to be injected, as determined in consultation with the treating physicians, and using topical anesthetic or local anesthetic, if the patient so desires. All patients in this cohort will be expected to agree to a minimum of one EPR Oximetry measurement in the planned radiation field prior to radiation and a minimum of one measurement made over the course of radiation therapy.

Other tumors within 5 mm of the surface, whose planned treatment includes radiotherapy of the tumor and does not include a planned resection of the tumor. As these other qualifying malignancies are expected to occur only rarely, they will be grouped into a single cohort despite potential varied histology. These patients will receive a Carlo Erba Ink injection in their tumor prior to radiation therapy. All patients in this cohort will be expected to agree to a minimum of one EPR Oximetry measurement in the planned radiation field prior to radiation and a minimum of one measurement made over the course of radiation therapy.

Carlo Erba India ink is used in this study as a paramagnetic oxygen sensor that is injected into tissue, and which, when measured using EPR Oximetry, can provide sensitive, repeated, and direct measurements of tissue oxygen. Each study participant will receive at least one ink injection of 20-50µL of Carlo Erba India Ink. The ink injection will occur within 5mm of the body surface (i.e., skin or mucosa), and may be injected into tumor, postsurgical field of radiation, and/or adjacent normal tissue. Carlo Erba Ink is an aqueous suspension composed of charcoal powder, water for injection, and a suspending agent. Carlo Erba is the name of the manufacturer that supplies the charcoal.

Carlo Erba Ink Injection

An oximetry measurement visit consists of \~ 30 minutes of continuous scans of tissue oxygen in vivo, using an oxygen sensor (i.e., India ink) injected into the tumor that is noninvasively scanned using EPR oximetry. Scans, converted into measurements of pO2, characterize the current tumor oxygen level at: (1) 'steady state' (while breathing room air), 2) response to hyperoxygenation therapy (inhaling oxygen-enriched air for 10 min), and 3) response to resuming inhaling room air. EPR measurements are repeated noninvasively throughout radiation or chemotherapy, to examine changes. The minimum number of visits depends on the patient's cohort; all may have additional measurements. If the ink injection is not surgically removed, EPR oximetry measurements can be repeated indefinitely.

EPR Oximetry Measurement

Philip E Schaner, M.D., Ph.D.

It has been well established that malignant tumors tend to have low levels of oxygen and that tumors with very low levels of oxygen are more resistant to radiotherapy and other treatments, such as chemotherapy and immunotherapy. Previous attempts to improve response to therapy by increasing the oxygen level of tissues have had disappointing results and collectively have not led to changing clinical practice. Without a method to measure oxygen levels in tumors or the ability to monitor over time whether tumors are responding to methods to increase oxygen during therapy, clinician's reluctance to use oxygen therapy in usual practice is not surprising.

The hypothesis underlying this research is that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, including combined therapy, and to minimize normal tissue side effects or complications. Because studies have found that tumors vary both in their initial levels of oxygen and exhibit changing patterns during growth and treatment, we propose to monitor oxygen levels in tumors and their responsiveness to hyperoxygenation procedures. Such knowledge about oxygen levels in tumor tissues and their responsiveness to hyper-oxygenation could potentially be used to select subjects for particular types of treatment, or otherwise to adjust routine care for patients known to have hypoxic but unresponsive tumors in order to improve their outcomes.

The overall objectives of this study are to establish the clinical feasibility and efficacy of using in vivo electron paramagnetic resonance (EPR) oximetry-a technique related to magnetic resonance imaging (MRI)-to obtain direct and repeated measurements of clinically useful information about tumor tissue oxygenation in specific groups of subjects with the same types of tumors, and to establish the clinical feasibility and efficacy of using inhalation of enriched oxygen to gain additional clinically useful information about responsiveness of tumors to hyper-oxygenation. Two devices are used: a paramagnetic charcoal suspension (Carlo Erba India ink) and in vivo EPR oximetry to assess oxygen levels. The ink is injected and becomes permanent in the tissue at the site of injection unless removed; thereafter, the in vivo oximetry measurements are noninvasive and can be repeated indefinitely.

The study design uses consecutively enrolled patients. Patients can participate as long as they are willing, fit the criteria for being assigned to a cohort, and the India ink spot remains measurable by EPR. Patients whose ink spot is resected during usual care and who do not have or are not willing to obtain additional injections will be withdrawn. Otherwise, patients can be re-measured using the previously injected ink at any time during the course of the study.

The study is split into four cohorts, with a minimum of 1-5 patients expected to be enrolled annually in each cohort, and a total of approximately 10 subjects expected for each cohort. The cohorts are defined by the type of tumor and by scenarios when our measurements will be made relative to the patient's standard therapies: 1) intraoral tumors with planned resection and adjuvant radiation therapy; 2) cutaneous malignant tumors receiving surgical resection only, receiving radiation therapy only, or receiving both surgical resection and adjuvant radiation therapy; 3) breast tumor receiving radiation therapy following surgery; and 4) other tumors receiving radiation therapy. The diagnosis for patients in all cases assumes that an eligible tumor (or the postsurgical area receiving radiation) occurs within approximately one-half centimeter of the surface, as determined by physical exam or imaging if available. All potentially eligible subjects are approached by their treating physician; those who agree to be contacted and are subsequently consented are assigned to the cohort for which they qualify. There is no randomization and no stratification within the cohorts.

Our interest in in situ tumor oxygenation relates to the clinical need to measure oxygen in tumors prior to therapy, to understand tumor oxygen dynamics over the course of therapy, and to assess the effectiveness of oxygen modulation therapy during treatment. Our interest in the postsurgical radiation field relates to the clinical need to understand whether the temporal dynamics of oxygen within the postsurgical radiation field has the potential to enhance the effectiveness of adjuvant therapies, and to understand how changes in short and long term oxygenation within the postsurgical radiation field may facilitate diminishment of late side effects from surgery and/or radiotherapy.

Following enrollment in the study, each subject will receive an initial placement of one or more geographically separate injections of India ink into the tissue of interest (i.e., tumor and/or tumor bed and/or adjacent tissue) using the established procedures for the injection of the ink. The subject is expected to agree to periodic measurements of all injection sites (unless the ink injection has been surgically removed); the subject will be told to expect six or more visits for measurements during treatment, but must agree to have at least one measurement per injection site. Each measurement will typically consist of 3 ten minute consecutive periods during which the subject initially breathes room air, then 100% oxygen delivered through a non-rebreather face mask followed by a period breathing room air.

Patients will be evaluated during clinical and oximetry appointments with respect to the presence of any adverse events.

If the India ink tattoo site is surgically excised as part of standard care for the treatment of the tumor, molecular tests may be performed on the excised tissue surrounding the ink injection site to analyze for molecular biomarkers related to hypoxia, angiogenesis, and tumor growth. The tissue analysis will explore the potential for any identifying biomarkers of the tumor that predict or otherwise are associated with variation in tumor growth or responsiveness to therapy. Subjects may choose to opt of this portion of the study.

EPR Tumor Oximetry With CE India Ink

Tumor Oximetry Using Electron Paramagnetic Resonance (EPR) With India Ink (Using Carbon Particulates From Carlo Erba [CE])

For those subjects whose tumor is resected along with the tissue containing the India ink carbon particles as a part of their usual care, the tissue at the site of the injection will be submitted for processing with standard pathology procedures. Tissue sections spanning the injection site(s) will be evaluated for the extent and mechanism of dispersion and for the presence of acute or chronic inflammation or other tissue reaction (scar, fibrosis, capsule formation, or other). The tissue will be assessed as to whether the reaction observed is as expected for ink injections.

This study will assess whether the addition of hyperoxic therapy (100% oxygen delivered through a non-rebreather face mask) will increase the oxygen level of a tumor or tumor bed by \> 5 mm Hg using EPR oximetry. Tumor oxygen values will be reported in millimeters of mercury (mmHg).

This outcome will measure oxygen in the post-surgical tissue throughout the course of radiation therapy using EPR oximetry. Tissue oxygen values will be reported in millimeters of mercury (mmHg).

This outcome will measure tumor tissue oxygen throughout the course of radiation therapy using EPR oximetry. Tissue oxygen values will be reported in millimeters of mercury (mmHg).

For those subjects receiving India ink injections in both the untreated tumor and in the post-surgical bed prior to radiation, we will examine patterns across these two 'states' in individual tumors, which can enhance our understanding of the relationship between the oxygen levels in the tumor and in the resulting tumor bed. Tissue oxygen values will be reported in millimeters of mercury (mmHg).

For those subjects receiving India ink injections in both the untreated tumor and in the post-surgical bed while undergoing radiation therapy, we will examine patterns across these two 'states' in individual tumors, which can enhance our understanding of the relationship between the oxygen levels in the tumor and in the resulting tumor bed. Tissue oxygen values will be reported in millimeters of mercury (mmHg).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer	NCT03403049	Pancreatic Canc... Cancer	Carbon Ion Gemcitabine + C... Gemcitabine + C... Gemcitabine + E... Gemcitabine Photon	18 Years - 99 Years	Albert Einstein College of Medicine
Carbon Ion Radiation Therapy for Locally Advanced Pancreatic Cancer	NCT03403049	Pancreatic Canc... Cancer	Carbon Ion Gemcitabine + C... Gemcitabine + C... Gemcitabine + E... Gemcitabine Photon	18 Years - 99 Years	Albert Einstein College of Medicine
EPR Tumor Oximetry With CE India Ink	NCT03321903	Neoplasms, Mali... Breast Neoplasm Carcinoma, Basa... Carcinoma, Squa... Melanoma Skin Neoplasm Head and Neck N...	Carlo Erba Ink ... EPR Oximetry Me...	18 Years -	Dartmouth-Hitchcock Medical Center
EPR Tumor Oximetry With CE India Ink	NCT03321903	Neoplasms, Mali... Breast Neoplasm Carcinoma, Basa... Carcinoma, Squa... Melanoma Skin Neoplasm Head and Neck N...	Carlo Erba Ink ... EPR Oximetry Me...	18 Years -	Dartmouth-Hitchcock Medical Center

Spots Global Cancer Trial Database for carbon

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

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