Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma, Pancreatic Ductal

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Patients who received SOC and received IRE

Patients who received SOC and did not receive IRE

NanoKnife System

This multicenter, observational study will evaluate the effectiveness and safety of the NanoKnife System when used for the ablation of Stage 3 pancreatic adenocarcinoma (Stage 3 PC). Eligible patients will be recruited over a 36-month period and participating institutions will enroll and provide data on consecutive patients that meet inclusion and exclusion criteria. Each patient will be followed up for the duration of the study or until death. The study will include two (2) cohorts: patients who received standard of care (SOC) and received irreversible electroporation (IRE) \[IRE cohort\], and patients who were treated with SOC and did not receive IRE \[SOC cohort\].

A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer

Registry to Evaluate Effectiveness and Safety of the NanoKnife System for the Ablation of Stage 3 Pancreatic Adenocarcinoma

To evaluate the effectiveness of the NanoKnife System when used for the ablation of Stage 3 PC in real world treatment settings, by testing the hypothesis that IRE with the NanoKnife System improves overall survival (OS)

Angiodynamics, Inc.

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Single arm study: Percutaneous irreversible electroporation of locally advanced pancreatic carcinoma

Tumor ablation with irreversible electroporation with the NanoKnife

NanoKnife "Irreversible electroporation (IRE)"

Martijn R Meijerink, MD, PhD

Geert Kazemier, Prof. Dr.

Cornelis van Kuijk, Prof. Dr.

Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis.

The purpose of this study is to investigate the safety of percutaneous IRE in the treatment of patients with locally advanced pancreatic carcinoma (LAPC). Other objectives are feasibility and efficacy of IRE based upon symptomatic response and tumor response.

Fourty patients with histologically confirmed locally advanced pancreatic adenocarcinoma (\<5cm) will undergo percutaneous irreversible electroporation of the tumor using CT and ultrasound guidance. After IRE, patients will be carefully monitored and any (serious) adverse events are registered. Follow-up will consist of frequent CT scanning, as well as serum CA19.9 tumor marker.

We hypothesize that IRE in the pancreas will induce good symptom palliation and local tumor control, without causing severe complications.

PANFIRE Study: Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma

PANFIRE - Pilot-study: Non-thermal Ablation Using Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma - a Phase I Clinical Trial

Number of adverse events of IRE-treatment (within 12 months after treatment) are registered and analyzed according to the CTCAE version 4.0. Complications related to IRE are early complications during hospital admission (e.g. bile leak, bowel leak, infection, pancreatitis), or late complications of IRE such as bile duct stenosis that become apparent during follow-up in the year after treatment.

* Ablation success: the ability to deliver the planned therapy and at 3 months to have no evidence of residual tumor;
* Local recurrence rate (LRR): defined as the reappearance of viable tumor after a period of time during which viable tumor could not be detected;
* Overall survival and (local and distant) progression-free survival.

Amsterdam UMC, location VUmc

Antineoplastic Agents

Vorinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.

Dose of 50.4 Gy in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.

Chemoradiation (Radiation Therapy)

Starting Dose of 200 mg orally once daily, Monday to Friday, Weeks 1 to 6.

Sunil Krishnan, MD

Primary Endpoint:

To determine the maximum tolerated dose (MTD) of vorinostat + radiation therapy (RT) in patients with locally advanced pancreatic cancer (LAPC).

Secondary Endpoints:

1. To assess the efficacy of vorinostat + RT in patients with LAPC as estimated by median overall survival.
2. To determine the radiological response as assessed by regular computer tomography (CT) and/or dynamic contrast enhanced computer tomography (DCE-CT) among patients treated with vorinostat and RT.
3. To evaluate the occurrence of symptoms and correlate to disease progression and tolerance to treatment using the MD Anderson Symptom Inventory-Gastrointestinal Module (MDASI-GI) self-reporting tool.
4. To correlate serum cytokine levels with symptoms and treatment outcomes.

The Study Drugs:

Vorinostat is designed to interfere with the growth of cancer cells.

Study Drug Dose Level:

If you are found to be eligible to take part in the study, you will begin receiving vorinostat. The dose you receive will be based on how many participants have been enrolled before you, and on the safety data available. The first group of 3 enrolled participants will be given low doses of vorinostat. If no intolerable side effects occur, the next group of 3 will be enrolled at a higher dose level. The study doctor will tell you what dose you will be receiving and how it compares to the doses other participants have received. Up to 3 dose levels will be tested.

Study Drug Administration:

On each day that you receive radiation, you will take vorinostat (as a capsule taken by mouth) in the morning with food.

Radiation:

You will receive radiation once a day on Monday through Friday, except for holidays. This schedule will be continued for 5 1/2 weeks or 28 doses total. Each radiation treatment will usually last about 10-15 minutes.

Surgical Evaluation:

After completing radiation therapy, you will come back for a follow-up visit about 6-12 weeks later.

Length of Study:

You will remain on study for up to 5 1/2 weeks. You will be taken off-study early if the disease gets worse or intolerable side effects occur.

This is an investigational study. Vorinostat is FDA approved and commercially available. The use of vorinostat for pancreatic cancer and in combination with radiation is investigational. At this time, this combination is being used in research only.

Up to 37 patients will take part in the study. All will be enrolled at M. D. Anderson.

Vorinostat Plus Radiation Therapy in Pancreatic Cancer

Phase I/II Trial of Vorinostat and Radiation Therapy in Patients With Locally Advanced Pancreatic Cancer

MTD is maximum dose at which 6 patients are treated and there is at most 1 patient with dose limiting toxicities (DLT). Toxicities graded according to the Common Terminology Criteria for Adverse events (CTCAE).

Merck Sharp & Dohme LLC

M.D. Anderson Cancer Center

Vorinostat + Radiation Therapy

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Sunil Krishnan, MD / Associate Professor

Analysis per protocol; Of the three participants enrolled only two were eligible for MTD calculation.

Maximum Tolerated Dose (MTD) of Vorinostat + Chemoradiation

Overall Study

Micronutrients

Irinotecan

Leucovorin

Fluorouracil

Oxaliplatin

Folfirinox

Chemotherapy regimen of leucovorin, fluorouracil, irinotecan, and oxaliplatin

Modified FOLFIRINOX Regimen

Elizabeth Manning

Govindarajan Narayanan, MD

Thanh Tran

Vic Velanovich, MD

Henry Mantakul

Malcolm Bilimoria, MD

Mary Healey

Janine Schippang

Darius Desai, MD

Misbah Shabbir

Patricio Polanco, MD

Subjects will be offered the opportunity to participate in a randomized, controlled, 2-arm, unblinded multicenter trial (RCT). There will be 2 study arms: the control arm receiving chemotherapy with the modified FOLFIRINOX regimen alone; and the irreversible electroporation (IRE) arm, receiving chemotherapy with the modified FOLFIRINOX regimen followed by IRE with the NanoKnife System using either an open or a percutaneous approach. All subjects will be treated with the modified FOLFIRINOX regimen for at least 3 months; randomization to either control or IRE arm will take place at the time of completion of the 3 month modified FOLFIRINOX chemotherapy regimen. Randomization will be conducted centrally. Subjects will be randomized in a 1:1 ratio and must be found to have no evidence of disease progression after completion of the 3 month modified FOLFIRINOX chemotherapy regimen in order to participate in the RCT. All radiologic assessments will be performed as consistent with the imaging protocol. All post induction and post IRE treatments are left to the discretion of the treating physician. The minimum period of follow-up will be for 24 months or until death.

A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer

A Randomized, Multicenter, Controlled, Unblinded Study to Assess the Safety and Efficacy of the NanoKnife® System for the Ablation of Unresectable Stage 3 Pancreatic Adenocarcinoma

Time (in months) from randomization to the date of death for any reason

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Part I:

Gemcitabine + nab-paclitaxel:

• Administered per institutional standard every 7 days for 3 weeks

Part II:

Hypofractionated ablative pancreatic proton radiation therapy 67.5 Gy fractions once per day Monday - Friday for 3 weeks, for a total of 15 fractions.

Part III:

Surgery, if resectable, then adjuvant chemo per discretion of MD or no further therapy

OR

Chemo per discretion of MD if not resectable

Hypofractionated Ablative Proton Therapy

Jason Molitoris, MD

Jasmine A Newman, BS

Nicole Villa, MSN, RN

Keith Unger, MD

The purpose of this study is to determine the maximum tolerated dose of the chemotherapy drugs nab-paclitaxel and gemcitabine when combined with hypofractionated ablative proton therapy for the treatment of locally advanced pancreatic cancer. You will receive proton therapy once a day (Monday - Friday) for 3 weeks. Participants will also receive chemotherapy on each Monday of those three weeks.

The investigators propose a phase I trial to determine the maximum tolerable dose (MTD) and the recommended dose for phase II (RP2D) of concurrent nab-paclitaxel + gemcitabine in combination with ablative IMPT delivered as a fixed dose of 67.5 Gy in 15 fractions daily fractions with 5 fractions per week. In contrast to prior pancreatic cancer studies of chemoradiotherapy which utilized photon RT to treat gross disease and elective lymph nodes (1,2) the proposed study is hypothesized to reduce toxicity risk by limiting highly conformal IMPT to the gross tumor volume. Furthermore, to increase the margin of safety in a manner similar to published data from MDACC (3), the high dose region will be limited to areas at least 5 mm from nearby GI structures (duodenum, small bowel, stomach, etc.). Regions within this area will be treated only to 37.5 Gy in 15 fractions. This dose limitation is also important given that paclitaxel, in addition to increasing systemic efficacy, is a known radiosensitizer (1).

Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)

Phase I Study of Concurrent Nab-Paclitaxel + Gemcitabine With Hypofractionated, Ablative Proton Therapy for Locally Advanced Pancreatic Cancer

Maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of concurrent nab-paclitaxel + gemcitabine combined with hypofractionated ablative proton therapy for the treatment of locally advanced pancreatic cancer.

Primary tumor response in patients receiving with LAPC receiving preoperative concurrent nab-paclitaxel + gemcitabine combined with hypofractionated ablative proton therapy evaluated by CT or MRI

Time to recurrence and site of recurrence in patients with LAPC receiving preoperative concurrent nab-paclitaxel + gemcitabine combined with hypofractionated ablative proton therapy (RECIST)

Median overall survival of patients with LAPC receiving preoperative concurrent nab-paclitaxel + gemcitabine combined with hypofractionated ablative proton therapy

R0 resection rates in patients with LAPC receiving preoperative concurrent nab-paclitaxel + gemcitabine combined with hypofractionated ablative proton therapy

Number of toxicities participants reported by participants during and following treatment of concurrent nab-paclitaxel + gemcitabine combined with hypofractionated ablative proton therapy (NIH CTCAE v 4)

Patient reported quality of life impact from receiving preoperative concurrent nab-paclitaxel + gemcitabine combined with hypofractionated ablative proton therapy using the FACT-Hep questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer	NCT03899649	Stage III Pancr...	SOC NanoKnife Syste...	18 Years -	Angiodynamics, Inc.
PANFIRE Study: Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma	NCT01939665	Locally Advance... Non-metastasize... Pancreatic Canc...	NanoKnife "Irre...	18 Years -	Amsterdam UMC, location VUmc
Vorinostat Plus Radiation Therapy in Pancreatic Cancer	NCT00831493	Pancreatic Canc...	Chemoradiation ... Vorinostat	18 Years -	M.D. Anderson Cancer Center
Vorinostat Plus Radiation Therapy in Pancreatic Cancer	NCT00831493	Pancreatic Canc...	Chemoradiation ... Vorinostat	18 Years -	M.D. Anderson Cancer Center
A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer	NCT03899636	Stage III Pancr...	Modified FOLFIR... NanoKnife Syste...	18 Years -	Angiodynamics, Inc.
A Registry Study of NanoKnife IRE for Stage 3 Pancreatic Cancer	NCT03899649	Stage III Pancr...	SOC NanoKnife Syste...	18 Years -	Angiodynamics, Inc.
Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)	NCT03652428	Locally Advance...	Gemcitabine Hypofractionate...	18 Years - 75 Years	University of Maryland, Baltimore
A Pivotal Study of Safety and Effectiveness of NanoKnife IRE for Stage 3 Pancreatic Cancer	NCT03899636	Stage III Pancr...	Modified FOLFIR... NanoKnife Syste...	18 Years -	Angiodynamics, Inc.

Spots Global Cancer Trial Database for lapc

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

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