Trials Open to Other Sites Joining
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LIVER
Inclusion Criteria: -Major liver resection (at least 3 segments resected or partially resected) -Posterior sectionectomy -Central resections -Resection of at least one full segment in a cirrhotic patient
Exclusion Criteria: -Age< 18 -Preoperative Hgb < 100 g/L -GFR < 60mL/min -Platelets < 100 -Active cardiac conditions -History of significant cerebrovascular disease -History of significant peripheral vascular disease -Pregnancy -Refusal of blood products -Presence of active infection -Preoperative autologous blood donation -Planned intraoperative use of cell saver
Open to Other Sites Joining? Yes
Principal Investigator: Guillaume Martel
PANCREAS
Inclusion Criteria: Histologically or Cytopathology confirmed pancreatic adenocarcinoma with initial diagnosis within 6 weeks of consent for patients who enroll at cycle 1, and from the start of cycle 1 of gemcitabine + nab-paclitaxel chemotherapy for patients who enroll at cycle 2
Locally advanced, unresectable disease at screening and prior to randomization, as defined by NCCN criteria determined by an on-site, experienced, multidisciplinary team (as confirmed by CT or MRI within 30 days of the start of cycle 1)
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
Age ≥ 18 years
Adequate laboratory values prior to receiving the first dose of nab-paclitaxel and gemcitabine: (criterion must be met prior to cycle 2.) For a subject with elevated bilirubin, AST or ALT, who has had a biliary stent placed, if the subject's lab values have returned to within the required range for eligibility noted below in sub-criteria e and f [(AST) ALT ≤ 3.0 X the upper normal limit, and total bilirubin ≤ 1.5 X the upper normal limit] after placement of stent and prior to cycle 2, he/she is eligible for the study. Additional detail regarding eligibility for subjects who have had biliary stents recently placed is outlined in sub-criteria f and h below.
Absolute neutrophil count (ANC) ≥ 1,500/μL
Platelet count ≥ 100,000/μL
Hemoglobin ≥ 9.0 g/dL
Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine >1.5 mg/dL
*Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 X the upper normal limit of institution's normal range
*Total bilirubin ≤ 1.5 X the upper normal limit of institution's normal range -OR- If biliary stent is placed or planned to be placed within 6 weeks of Cycle 1 Day 1 (C1D1), total bilirubin ≤ 2.0 X the upper normal limit of institution's normal range (see section 9.1.4 for dose modification due to elevated bilirubin)
Prothrombin time (PT) and partial thromboplastin time (PTT) must be ≤ 1.5 X upper normal limit of institution's normal range. Subjects who are currently taking anti-coagulant therapy are eligible if not meeting this criterion
International normalized ration (INR) ≤ 1.5 X upper normal limit of institution's normal range. Subjects who are currently taking anti-coagulant therapy are eligible if not meeting this criterion *For elevated AST, ALT, and total bilirubin at screening, subject must have a normalized result prior to initiation of Cycle 2 if abnormal labs are considered related to bile duct obstruction and a biliary stent has been placed
Life expectancy > 12 weeks
Negative pregnancy test for women of childbearing potential (either serum or urine) within one day prior to administration of the first dose of chemotherapy. Women of childbearing potential should use highly effective methods of contraception during treatment and for up to 6 months following treatment cessation
Provide written informed consent
Subjects willing to participate in the study for at least 8 months if randomized to IA gemcitabine OR IV gemcitabine + nab-paclitaxel
Exclusion Criteria: Any prior treatment for pancreatic cancer OR more than one cycle of gemcitabine and nab-paclitaxel treatment. For subjects who have started on their first cycle of gemcitabine and nab-paclitaxel treatment prior to consent, Inclusion Criterion #1 only applies to the first gemcitabine and nab-paclitaxel dose and must be within 6 weeks of confirmed diagnosis
Any evidence of metastatic disease or another active malignancy within the past one year except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
Subjects unable or unwilling to have their first randomized treatment within 3 weeks of the post induction imaging and within 5 weeks of their last induction treatment
Subjects without baseline tumor imaging
As determined by the Sponsor:
Arterial anatomy unsuitable for IA delivery of gemcitabine to the intended tumor site, determined by CT or MRI, as determined and approved by the Sponsor Imaging Advisor, which includes the following:
Stenosis or occlusion in the intended artery for treatment
Inability to exclude major side branches in the area of the intended RenovoCath® catheter occlusion
No suitable artery with a diameter greater than 3 mm in proximity of at least one side of the tumor
Superior mesenteric vein (SMV) occlusion or stenosis that cannot be resolved with medication or intervention prior to randomization, if the superior mesenteric artery (SMA) is the only viable treatment artery Note: Arterial Anatomy will be reviewed by the Sponsor, RenovoRx Imaging Advisor, and RenovoRx Medical Monitor for approval
Contraindications for SBRT planning which includes the following:
Gastrointestinal mucosal infiltration evident at the time of diagnostic endoscopy
Prior abdominal radiotherapy judged to have clinically significant degree of overlap with planned SBRT dose distribution Note: Primary tumors with a diameter greater than 7 cm must be assessed on a case-by-case basis with the RenovoRx Imaging Advisor prior to excluding the subject from the trial.
Subjects with known HIV infection or active viral hepatitis
Severe infections requiring hospitalization within 4 weeks prior to the first study treatment, including but not limited to complications of infection, bacteremia or severe pneumonia
Signs or symptoms of infection within 2 weeks prior to the first study treatment, as assessed by the Investigator
Received antibiotics for treatment of an infection within 48 hours prior to initiation of study treatment. Subjects receiving prophylactic antibiotics are eligible
History of severe allergic, anaphylactic, or other hypersensitivity reactions to gemcitabine or nab-paclitaxel
Any anti-cancer therapy including chemotherapy, hormonal therapy for prostate cancer, or radiotherapy within 2 weeks prior to initiation of study treatment; or herbal therapy intended as anti-cancer therapy within 1 week prior to initiation of study treatment
Subjects with uncontrolled seizures
Cardiovascular disease including unstable angina or life-threatening cardiac arrhythmia, myocardial infarction, stroke; or New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF) within the last 3 months prior to the first study treatment. Subjects with prior history of Myocardial Infarction (MI), congestive heart failure (CHF), coronary artery bypass grafting, or prior valve surgery need to have assessment of ejection fraction (EF) to ensure EF is not ≤ 40% (as determined by MRI, ECHO, or Nuclear Scan), within the last 3 months prior to the initiation of study treatment
Other severe concurrent disease or comorbidities which make it difficult to participate in this study, as assessed by Investigator
Any of the following procedures prior to initiation of study treatment:
Catheterization, endoscopy, stent or drain placement within 48 hours. (Diagnostic laparoscopy without surgical intervention and/or port placement do not require any wait time prior to study treatment)
Minor surgery requiring light sedation (such as surgical laparoscopy) within 2 weeks
Major surgery within 4 weeks
Women who are breastfeeding
Male or female subjects of reproductive potential who do not agree to either remain abstinent or employ highly effective and acceptable forms of contraception throughout their participation in the study and for 6 months after the last study treatment
Subjects receiving any other investigational agents within 2 weeks prior to the initiation of treatment
Any social situations or psychiatric illness that would limit compliance with study requirements
Subjects unable or unwilling to have standard catheterization procedure
Open to Other Sites Joining? Yes
Principal Investigator: Michael J Pishvaian
VIPR-1: Assessing ICG perfusion in predicting pancreatic leaks
Inclusion Criteria: Participant scheduled for open pancreaticoduodenectomy or distal pancreatectomy for any diagnosis
Participant ≥ 18 years of age
Ability to understand nature and individual consequences of clinical trial
Written informed consent from participant or legally authorized representative
For participants of childbearing potential, a negative pregnancy test and adequate contraception until 14 days after trial intervention
Participant needs to have an operative drain (any closed suction drain) after the procedure
Participants that do not require arterial reconstruction
Participants that require minor portal venous recounstructions including patch venoplasty
Exclusion Criteria: Patients with previous history of adverse reaction to contrast dye, ICG or components of the dye
Prior pancreatectomy
Known diagnosis of hepatic insufficiency, hepatitis, liver fibrosis or cirrhosis, or chronic pancreatitis
Because this study focuses on hypoperfusion, patients will be excluded if in postoperative day 3-5 had any of the following: persistent SBP < 90 mmHg unresponsive to 1L crystalloid, unexpected ICU transfer, blood transfusion of >2 units intraoperatively or 1 postoperatively, vasopressor treatment or ACLS protocol initiation
Organ failure, anuria or NSQIP-identified complication will be reviewed by PI and attending surgeon and excluded
Patients that require arterial reconstruction as part of their procedures
Open to Other Sites Joining? Yes
Principal Investigator: Patrick Worth
Inclusion Criteria: Resected pancreatic cancer w/o evidence of disease recurrence
Received ≥3mo multi-agent chemotherapy in the perioperative setting
Within 8 weeks of therapy completion
Pathogenic germline or somatic variant in BRCA or PALB2 (by local lab; confirmed by central review)
If variant identified in tissue, agreement to undergo germline testing
Exclusion Criteria: Any history of progressive disease during platinum therapy
Uncontrolled gastrointestinal disorder that would interfere with the absorption of olaparib
History of MDS/AML
Open to Other Sites Joining? Yes
Principal Investigator: Kim Reiss Binder
Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program
Inclusion Criteria: Adults age 18 years or older. Diagnosed within 8 weeks with upfront resectable, borderline resectable, or locally advanced unresectable PDAC as defined by the National Comprehensive Cancer Network (NCCN). Planning to undergo TNT at MGH. Planning to receive modified FOLFIRINOX for neoadjuvant chemotherapy. Planning to undergo surgical resection of PDAC at MGH. Verbal fluency in English.
Exclusion Criteria: Adults age 18 years or older. Diagnosed within 8 weeks with upfront resectable, borderline resectable, or locally advanced unresectable PDAC as defined by the National Comprehensive Cancer Network (NCCN). Planning to undergo TNT at MGH. Planning to receive modified FOLFIRINOX for neoadjuvant chemotherapy. Planning to undergo surgical resection of PDAC at MGH. Verbal fluency in English.
Open to Other Sites Joining? Potential for phase III expansion
Principal Investigator: Motaz Qadan
Inclusion Criteria: PRE-REGISTRATION: Pathology: Histologic or cytologic proof of pancreatic adenocarcinoma or adenosquamous carcinoma TNM Stage: Tx-4, N0-1, M0 (M0 disease does not include spread to distant lymph nodes and organs) Resectable Primary Tumor: Local radiographic reading must be consistent with resectable disease defined as the following on 1) arterial and venous phase contrast-enhanced abdominal/pelvic CT scan or abdominal/pelvic magnetic resonance imaging (MRI) scan and 2) chest CT: No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery (if applicable) Less than 180 degree interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence No evidence of metastatic disease Measurable disease or non-measurable disease o Non-measurable disease is defined as cytologic or histologic confirmation of adenocarcinoma of adenosquamous carcinoma by fine needle aspiration or core-biopsy of the pancreas without measurable disease by radiographic imaging REGISTRATION: Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at Imaging and Radiation Oncology Core (IROC) Ohio Determined to be appropriate candidate for curative-intent pancreatectomy by surgeon intending to perform the resection No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Total Neuropathy Score < 2 Absolute neutrophil count (ANC) >= 1,500/uL Platelet count >= 100,000/uL Total bilirubin =< 1.5 x upper limit of normal (ULN) (If obstructive jaundice is present, then biliary drainage must be initiated and total bilirubin =< 3.0) Creatinine =< 1.5 x ULN OR calculated (Calc.) creatinine clearance >= 30 mL/min (Calculated using the Cockcroft-Gault equation) No known Gilbert's Syndrome or known homozygosity for UGAT1A1*28 polymorphism No comorbid conditions that would prohibit curative-intent pancreatectomy Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration Chronic concomitant treatment with strong inducers of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inducers must discontinue the drug prior to registration
Exclusion Criteria: Confirmation of resectable disease by real-time central imaging review by the Alliance Imaging Core Lab at IROC Ohio. Determined to be appropriate candidate for curative-intent pancreatectomy by surgeon intending to perform the resection.
Open to Other Sites Joining? Yes
Principal Investigator: Cristina Ferrone and Akhil Chawla
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 AND REGISTRY TO EVALUATE EFFECTIVENESS AND SAFETY OF THE NANOKNIFE SYSTEM FOR THE ABLATION OF STAGE 3 PANCREATIC ADENOCARCINOMA
Inclusion Criteria: RCT: 1. Provision of signed and dated informed consent form. 2. Subject is 18 years of age and older. 3. Subject has a diagnosis of unresectable Stage 3 pancreatic adenocarcinoma cancer cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria. 4. Subject has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery. 5. Maximum axial and anterior to posterior tumor dimension of ≤3.5cm, after receiving three months of treatment with the modified FOLFIRINOX regimen. 6. Subject has received 3 months of treatment with the modified FOLFIRINOX regimen. 7. Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Subject has an American Society of Anesthesiologists (ASA) classification of physical health status of 1, 2, 3 or 4. Registry: 1. Provisions of signed and dated informed consent form 2. Patient is 18 years of age and older 3. Patient has a diagnosis of Stage 3 PC cytologically or pathologically confirmed per American Joint Committee on Cancer (AJCC) staging criteria 4. Patient has a tumor evaluated as Stage 3 according to National Comprehensive Cancer Network (NCCN) guidelines, based on radiographic imaging or exploratory surgery 5. Maximum axial and anterior to posterior tumor dimension of ≤3.5cm after SOC 6. Patient has received 3 months of SOC per each participating institution's guidelines 7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8. Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1, 2, 3 or 4 9. Patients at IRE sites who are deemed eligible for IRE and receive ablation using the NanoKnife System 10. Patient shows no evidence of disease progression based on NCCN guidelines after completing three (3) months of SOC
Exclusion Criteria: RCT: 1. Subjects who are or may be pregnant as determined by a positive pregnancy test or breastfeeding or male or female subjects of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy. 2. Subjects who are unable to tolerate general anesthetic with full skeletal muscle blockade. 3. Subjects who are actively bleeding, anticoagulated, coagulopathy, or have any of the following hematology results: hemoglobin less than 10 g/dL without the support of growth factors or transfusions; absolute neutrophil count less than 1500 cells/mL; or platelet count less than 100,000. 4. Subjects with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE. 5. Subjects with history of epilepsy or other neurological disease. 6. Subjects with renal, cardiac, liver, or hematological abnormalities of concern to the investigator. 7. Subjects with Stage 3, 4, or 5 chronic kidney disease. 8. Subjects receiving IRE for margin accentuation. 9. Subjects who at 3 months after FOLFIRINOX treatment have evidence of disease progression. 10. Participation in another interventional trial for pancreatic cancer. 11. Subjects who did not meet study defined criteria for adequacy of induction treatment at the end of the 3 months. Registry: 1. Participation in an interventional trial for pancreatic cancer during the study data collection period 2. Pregnant or lactating patients or male or female patients of reproductive potential who are not willing to employ highly effective birth control from screening to 6 months after the last dose of chemotherapy 3. Patients who are unable to tolerate general anesthetic with full skeletal muscle blockade 4. Patients with the presence of implanted cardiac pacemakers, defibrillators, electronic devices or implanted devices with metal parts in the thoracic cavity at the time of IRE
Open to Other Sites Joining? Yes
Principal Investigator: Robert Martin
BIlIARY
Inclusion Criteria: Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Agreement to allow the use of archival tissue from diagnostic tumor biopsies
If unavailable, exceptions may be granted with study principal investigator (PI) approval
Age: >= 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically or cytologically confirmed intrahepatic cholangiocarcinoma or extrahepatic cholangiocarcinoma or gallbladder cancer
Documented metastatic disease on computed tomography (CT) imaging or magnetic resonance imaging (MRI). CT scan or MRI to assess measurable disease must have been completed within 28 days prior to registration
Visible peritoneal metastatic disease on cross-sectional imaging or diagnostic laparoscopy (does not have to be measurable by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Fully recovered from acute toxic effects (except alopecia, hearing loss, or non-clinically significant laboratory abnormalities) =< grade 1 of prior anti-cancer therapy
Complete medical history and physical exam (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
Absolute neutrophil count (ANC) >= 1,500/mcL (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
Platelets >= 100,000/mcL (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
Hemoglobin >= 8 g/dL (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
Serum albumin >= 2.8 g/dL (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
Total bilirubin =< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease, then direct bilirubin < 1.5 mg/dL) (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
Aspartate aminotransferase (AST) =< 5 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
Alanine aminotransferase (ALT) =< 5 x ULN (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
Calculated creatinine clearance of >= 45 mL/min per 24 hour urine test or the Cockcroft-Gault formula (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
If seropositive, patient may be eligible if they are stable on antiretroviral therapy, have a CD4 T cell count >= 200/µL, and have an undetectable viral load
Documented virology status of hepatitis, confirmed by hepatitis B virus (HBV) and hepatitis C virus (HCV) tests (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
For patients with active HBV, HBV deoxyribonucleic acid (DNA) < 500 IU/mL during screening, initiation of anti-HBV treatment at least 14 days prior to day 1 of cycle 1, and willingness to continue anti-HBV treatment during the study (per standard of care)
If seropositive for HCV, nucleic acid quantification must be performed. Viral load must be undetectable
Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 28 days prior to day 1 of protocol therapy unless otherwise stated)
If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Agreement by females and males of childbearing potential* to use an effective method of birth control (e.g. licensed hormonal/barrier methods or surgery intended to prevent pregnancy [or with a side effect of pregnancy prevention]) or abstain from heterosexual activity for the course of the study through at least 14 months after the last dose of protocol therapy
Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
Exclusion Criteria: Any prior systemic therapy treatment for advanced cholangiocarcinoma or gallbladder cancer
Any prior adjuvant therapy (chemotherapy, radiation therapy, biological therapy, immunotherapy) completed < 6 months prior to registration
Strong CYP3A4 inducers/inhibitors within 14 days prior to day 1 of protocol therapy
Bowel obstruction requiring nasogastric tube, percutaneous endoscopic gastrostomy, or exclusive total parenteral nutrition
Evidence of liver metastases with >= 50% liver occupation
Any history of, or current, brain or subdural metastases
Life expectancy < 3 months
History of peripheral neuropathy >= grade 2 measured by NCI CTCAE version 5.0 ("moderate symptoms, limiting instrumental activities of daily living")
Treatment with therapeutic oral or IV antibiotics within 14 days prior to day 1 cycle 1 of treatment
Patients receiving prophylactic antibiotics are eligible, provided the signs of active infection have resolved
Any prior malignancy except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for two years
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents (platinum-based compounds, etc.)
Clinically significant uncontrolled illness
Females only: Pregnant or breastfeeding
Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Open to Other Sites Joining? Contingent on Funding
Principal Investigator: Mustafa Raoof
Inclusion Criteria: Patient must be ≥ 18 years of age. Patient must have an ECOG performance status of 0-1. Patient must have histologically-confirmed T2 or T3 gallbladder cancer discovered incidentally at the time of or following routine cholecystectomy for presumed benign disease NOTE: Patients with histologically-confirmed Tis, T1a, T1b, or T4 tumors are not eligible Patient must have undergone initial cholecystectomy within 12 weeks prior to randomization Patient must not have any evidence of metastatic disease or inoperable loco-regional disease based on high-quality, preoperative, cross-sectional imaging (CT or MRI) of the chest, abdomen, and pelvis (C/A/P) obtained within 6 weeks prior to randomization, defined as • No radiographic evidence of distant disease (M1 disease) • No radiographic evidence of tumor invasion into multiple extrahepatic organs (T4 disease) • No radiographic evidence of distant lymph node involvement (celiac, para-aortic, para-caval lymph nodes) • No evidence of new-onset ascites • Soft tissue thickening within or in direct communication with the gallbladder fossa, peri-portal lymph node involvement, involvement of one extrahepatic organ, and other disease within the confines of what constitutes 'localized resectable' disease are allowable
Exclusion Criteria: Metastatic disease at presentation T1a, T1b, T4 disease Non-incidental GB Cancer Not candidates for re-resection
Open to Other Sites Joining? Yes
Principal Investigator: Shishir Maithel