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Hematinics

Dexamethasone

Gemcitabine

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Docetaxel

Chrysarobin

Dexamethasone acetate

Darbepoetin alfa

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Antimitotic Agents

Patients with only venous involvement Treated with 6 cycles og GTX and then surgery

Patients with arterial involvement and may have venous involvement with tumor treated with 6 cycles of GTX, thenb GX/RT and then surgery

6 cycles of gemcitabine, capecitabine, and docetaxel. One cycle consists of a 2-week regimen followed by one week off.

Days 1-14: Capecitabine at 1500mg/m2/day divided into two doses given orally with breakfast and dinner.

Days 4 and 11: Gemcitabine at 750mg/m2 over 75 minutes IV followed by docetaxel at 30mg/m2 over 30 minutes IV with 10mg of dexamethasone IV prior to treatment.

Neoadjuvant gemcitabine, capecitabine, and docetaxel

6 cycles of gemcitabine, capecitabine, and docetaxel. One cycle consists of a 2-week regimen followed by one week off.

Days 1-14: Capecitabine at 1500mg/m2/day divided into two doses given orally with breakfast and dinner.

Days 4 and 11: Gemcitabine at 750mg/m2 over 75 minutes IV followed by docetaxel at 30mg/m2 over 30 minutes IV with 10mg of dexamethasone IV prior to treatment.

Radiotherapy should start 2 to 3 weeks after last planned dose of GTX. Gemcitabine at 750mg/M2 days 5, 12, 26, 33 along with capecitabine 1000 mg bid for 5 days darbepoetin 200ug, every 2 weeks if the hemoglobin is less than 10.5 gms/dl while undergoing radiotherapy.

Pegfiligastrim 6mg at the end of week 2 if the WBC count is less than 2500 cells/cu mm.

Gemcitabine, capecitabine, docetaxel followed by radiotherapy

Kyung Chu, RN

Jessica Neufield

William Sherman, MD

John Allendorf, MD

John Chabot, MD

Beth Schrope, MD

Kyung Chu, NP

Robert Fine, MD

This study is for patients with locally advanced pancreatic cancer (cancer that involves the local blood vessels so it cannot be removed without cutting major blood vessels) that cannot be treated with surgery. The purpose of this study is to assess the safety and benefit of 6 three week cycles of chemotherapy treatment consisting of gemcitabine, capecitabine and docetaxel (also called 'GTX'). The patients fall into two groups. Group I are those with only venous involvement. Group II patients have arterial involvement and may also have venous involvement. If there is arterial involvement, GTX will be followed by 5 and 1/2 weeks of radiation therapy with gemcitabine and capecitabine. After the chemotherapy and radiation treatment, participants may be able to have surgery to remove any remaining pancreatic cancer.

Neoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)

Phase II Study: Neoadjuvant Gemcitabine, Docetaxel and Capecitabine Followed by Neoadjuvant Radiation Therapy With Gemcitabine and Capecitabine in the Treatment of Stage II and III Pancreatic Adenocarcinoma

Columbia University

Associate Professor of Clinical Medicine

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Individuals diagnosed with pancreatic ductal adenocarcinoma

Individuals without pancreatic ductal adenocarcinoma

This test will utilize quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) to quantify the expression levels of 5 cell-free and 8 exosome-miRNAs in plasma samples obtained from patients with pancreatic ductal adenocarcinoma and from individuals without it

PANcreatic cancer Exosome Early detectiON (PANXEON)

Ajay Goel, PhD

Daniel Von Hoff

Haiyong Han

Derek Cridebring

Erkut Borazanci

Ajay Goel

Stanley Hamilton

Vincent Chung

Caiming Xu

Alessandro Mannucci

Michael Demeure

Chandler Wilfong

John Bolton

Angela Alistar

Eric Whitman

Andrew Page

Eyal Meiri

Douglas Evans

Yasuhiro Kodera

Masamichi Hayashi

Song Cheol Kim

This study aims to prospective validate an exosome-based miRNA signature for noninvasive and early detection of pancreatic ductal adenocarcinoma.

Pancreatic ductal adenocarcinoma (PDAC) is one of the deadliest forms of cancer. It often goes undetected until it is at an advanced stage, making it challenging to treat. Currently, only a small percentage of patients are diagnosed early enough for effective treatment. While a blood marker exists, called serum carbohydrate antigen 19-9 (CA19-9), it is used primarily to track the disease and it is unreliable for early detection.

To address this problem, the researchers have developed a new method to analyze circulating vesicles (called exosomes), which contain specific genetic material called microRNAs (miRNAs). In a previous study, by analyzing both the miRNAs that circulate freely in serum and the miRNAs that are inside the exosomes, the researchers have already identified a combination of 13 miRNAs that could accurately detect early-stage PDAC.

In this study, the researchers will test this method in a larger international cohort study. This study aims to confirm the effectiveness of this approach in accurately identifying PDAC at its earliest stages.

Pancreatic Cancer Detection Consortium

Early Detection of Pancreatic Cancer: Prospective Study

Data collected for the study will be made available to others, including de-identified participant data, at publication, via a signed data access agreement and at the discretion of the investigators' approval of the proposed use of such data

True positive rate: the probability of a positive test result, conditioned on the individual truly being positive

True negative rate: the probability of a negative test result, conditioned on the individual truly being negative

A measure of trueness: proportion of correct predictions (both true positives and true negatives) among the total number of cases examined

City of Hope Medical Center

Paclitaxel

Albumin-Bound Paclitaxel

Pancrelipase

Pancreatin

ARM A: nab-paclitaxel 125 mg/mq over 30 min and gemcitabine 1000 mg/mq weekly on days 1, 8 and 15 of a 28-day cycle

ARM B: Gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.

Chemotherapy will consist of nab-paclitaxel 125 mg/mq over 30 min and gemcitabine 1000 mg/mq weekly on days 1, 8 and 15 of a 28-day cycle

Nab-paclitaxel and Gemcitabine

gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.

Stefano Cascinu, PhD

Pancreatic cancer is the fourth cause of cancer mortality: there are different treatment approaches to locally advanced pancreatic cancer management.

Generally, gemcitabine alone is considered a reasonable approach for advanced pancreatic cancer patients but we need a chemotherapeutic regimen able to prevent as much as possible a progression of the disease. Nab-paclitaxel (Abraxane) recently demonstrated an interesting activity profile in advanced pancreatic cancer. A combination of Nab-paclitaxel and gemcitabine has been demonstrated superior to gemcitabine alone in metastatic patients.

Study population: Locally advanced unresectable pancreatic cancer patients

Elegibility criteria:

* Written informed consent
* Age \>18 \< 75 years
* Histologically/cytologically confirmed locally advanced, unresectable pancreatic cancer
* At least one lesion measurable with CT or MRI scan
* Performance Status (ECOG) 0-1 at study entry
* Life expectancy of at least 3 months
* Adequate marrow, liver and renal function
* Effective contraception if the risk of conception exists (in the Informed Consent for the patients the descriptions of possible contraceptives is reported

Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.

A Phase II Randomized Trial Comparing a Combination of Abraxane and Gemcitabine Versus Gemcitabine Alone as First Line Treatment in Locally Advanced Unresectable Pancreatic Cancer. GAP (Gemcitabine Abraxane Pancreas) Trial

Assuming an expected progression rate in the control arm of 40% and an auspicated progression rate in the experimental arm of 20%,with one-tailed alpha=0.05, 80% power, 124 patients are required for the final analysis

All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations

Treatment-emergent adverse events, drug-related adverse events and safety laboratory parameters will be analysed by treatment groups and CTCAE grade

Progression free survival time will be defined as the time from randomization until the date of first observed disease progression (radiological or clinical, whichever is earlier) or death due to any cause, if death occurs before progression is documented.

Patients who did not progress will be censored at the last date they were known to be alive.

Patients who died of disease and for whom a date of progression is not available will be considered to have progressed on the day of their death

Overall survival time will be defined as the time from randomization to the date of death. If the subject has not died, survival will be censored on the last date the subject was known to be alive (last date of follow up).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)	NCT01065870	Pancreatic Canc... Pancreatic Canc...	Neoadjuvant gem... Gemcitabine, ca...	18 Years -	Columbia University
Pancreatic Cancer Detection Consortium	NCT06388967	Pancreatic Canc... Pancreatic Carc... Pancreatic Aden... Pancreatic Duct... Pancreatic Neop... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc...	PANcreatic canc...	18 Years -	City of Hope Medical Center
Neoadjuvant GTX With Chemoradiation for Pancreatic Cancer (Stage II/III)	NCT01065870	Pancreatic Canc... Pancreatic Canc...	Neoadjuvant gem... Gemcitabine, ca...	18 Years -	Columbia University
Abraxane and Gemcitabine Versus Gemcitabine Alone in Locally Advanced Unresectable Pancreatic Cancer.	NCT02043730	Pancreatic Canc...	Nab-paclitaxel ... Gemcitabine	18 Years - 75 Years	Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Pancreatic Cancer Detection Consortium	NCT06388967	Pancreatic Canc... Pancreatic Carc... Pancreatic Aden... Pancreatic Duct... Pancreatic Neop... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc... Pancreatic Canc...	PANcreatic canc...	18 Years -	City of Hope Medical Center

Spots Global Cancer Trial Database for pancreatic cancer stage ii