Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Mitogens

Folfirinox

Neoadjuvant Chemotherapy- Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles for 3 cycles with growth factor support Chemoradiation Surgical Resection

1. Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles, for three (3) cycles with growth factor support.
2. Restaging # 1. (CT or MRI; use same modality as baseline staging unless otherwise indicated by Study Team)

   1. Progressive Disease (PD) → Off study. Subsequent treatment per patient's primary MD.
   2. Stable Disease (SD) or Tumor Response → Continue to Registration #2 for Chemoradiation.

Neo-adjuvant Chemotherapy

1. Chemoradiation may be administered at selected approved CTN sites.
2. Determination of resectability as reviewed and documented by MUSC-HCC GI Tumor Board.

   1. Unresectable → Off study. Subsequent treatment per patient's primary MD.
   2. Resectable → Continue to Registration #3 for Surgical Resection

Chemoradiation

1. Meets criteria for resectable\* →pancreaticoduodenectomy (POD)
2. At time of resection, snap frozen tumor specimen sent for correlative biomarker studies

Surgical Resection

Paul E. O'Brien, MD

This study is for subjects with adenocarcinoma of the pancreas. The purpose of this research study is to determine the safety and effectiveness of modified Folfirinox and radiation therapy as treatment for adenocarcinoma (cancer) of the pancreas before surgery. Screening tests will be done to determine if subjects are eligible for participation in this study. If subjects are eligible to participate and agree to participate they will begin chemotherapy. After 3 cycles of chemotherapy, subjects will begin chemoradiation. Within 4 to 8 weeks of completing radiation therapy, subjects will have surgery. There will also be post-treatment and follow-up evaluations. Subjects will be followed for every 3 months for 3 years after their initial registration.

Neoadjuvant Folfirinox Followed by Capecitabine and Limited Field Radiation for Localized Pancreatic Head Adenocarcinoma

Phase II Study of Neoadjuvant Folfirinox Chemotherapy Followed by Capecitabine With Concurrent Limited Field Radiation Therapy in Patients With Localized Pancreatic Head Adenocarcinoma

The feasibility of treating patients with localized pancreatic head adenocarcinoma with this neoadjuvant regimen will be evaluated by estimating the proportion of patients completing five of six planned doses. The analysis population will be the ITT population.

To evaluate and describe CTC numbers, CTC phenotype characteristics and effectiveness/rate of CTC culturing techniques from patients with pancreatic adenocarcinoma.

To determine and evaluate the correlation between expression or biomarkers in the CTCs and expression of biomarkers in resected tissue specimens within the same cancer patient.

Estimate the R0/R1 resection rate as the proportion of patients with R0 or R1 resection status based on the ITT population. R0 resection status is macroscopic complete removal of tumor by non-contaminated operation, with neither macroscopic nor microscopic residual tumor. R1 resection status is macroscopic complete removal of tumor by non-contaminated operation, with microscopic residual tumor.

The rate of CR, PR, SD and PD will be estimated as described in Section 14B prior to chemoradiation start and prior to surgery. The analysis population for estimation of radiographic response rate will be the ITT population.

Estimate the rate of good histopathologic response as the proportion of grade I and II responders. The analysis population for this objective is the ITT population. Any patient for whom a surgical sample is not available will be considered a poor-responder.

Time to recurrence is defined as the time from surgical resection to disease recurrence or death from any cause. Patients who have not recurred at the end of follow up will have their recurrence time censored at the last date of contact.

Overall survival is defined as the time from enrollment to death from any cause. Patients still alive at the end of follow up will have their survival time censored at the last date of contact.

Medical University of South Carolina

Assistant Professor

AEs are reported from the start of chemotherapy to the end of study treatment. Any medically significant AEs, which are ongoing at the end of study treatment should be followed until the event is resolved or considered stable.

Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection

Chemotherapy, Chemoradiation, Surgery

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Paul O'Brien, MD

R0 resection status

R1 resection status

Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for -08 weeks, then surgical resection

Only subjects who had surgery were included in the outcome measure data.

Estimate the R0/R1 Resection Rate

SD before chemoradiation

PD before chemoradiation

SD before surgery

All subjects enrolled and had a response assessment are included in the outcome measure below.

Radiographic Tumor Response

Only subjects who had surgery were included in this outcome measure.

Histopathologic Tumor Response

The study terminated early, prior to the follow up period being completed. Only one subject had surgery and that subject is still alive at the time of study termination, so time to recurrence cannot be estimated.

Time to Recurrence:

The study terminated early, prior to the end of the follow up period for all subjects. At the time of study termination, one subject had expired and the time from enrollment to death for that subject is reported below.

Overall Survival:

The number of subjects who had 5-6 doses of neoadjuvant regimen

Feasibility Objective

The CTC analysis was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed.

CTC Analysis

The CTC expression endpoint was added as an amendment. No subjects were enrolled to the study after this amendment was approved, so data for this outcome was not collected or analyzed.

CTC Expression

Overall Study

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Cholangiocarcinoma

Pancreatic Cancer

Bile Duct Cancer

patients will be randomized to laparoscopic pancreatoduodenectomy group

Patients will be randomized to Open pancreatoduodenectomy

Open surgery

Laparoscopic surgery

Senthilnathan Palanisamy, MS, DNB

Palanivelu Chinnusamy, MS, MCh

Sandeep Sabnis, MS

The aim of this study is to compare the two surgical approaches namely laparoscopic pancreatoduodenectomy and open pancreatoduodenectomy for management of periampullary and pancreatic head cancers in terms of parameters like hospital stay, pathological radicality, complication rate, peri-operative and post operative outcomes.

Laparoscopic pancreatoduodenectomy (LPD) although technically difficult, requiring high degree of expertise, has shown equal efficacy in terms of complications, oncological safety \& overall outcome to that of open pancreatoduodenectomy (OPD) with advantages of minimally invasive surgery like decreased blood loss, reduced pain, shorter hospital stay \& early return to work.

Although current literature from various centres supports its use, the studies done so far are, case comparisons of either small sample of population or non-randomized trials. According to our knowledge, a randomized trial analyzing open versus laparoscopic pancreatoduodenectomy (PD) in terms of complications and outcome, has not been reported. With this current study we will try to address this issue.

This study is a prospective, randomized, parallel group, controlled trail comparing laparoscopic versus open pancreatoduodenectomy in relation to the hospital stay, peri-operative parameters, pathological radicality \& complications.

This is a single institute based trial, being conducted at GEM hospital and research center, Coimbatore, TN, India. The trial has been approved by the GEM Hospital ethical committee.

Through this trial we are planning to enroll patients having resectable periampullary and pancreatic head malignant lesion at diagnosis. After full assessment, optimization, approval of hospital tumor board with informed consent, those patients selected for surgical therapy with curative intention, will be randomized using computer generated random numbers either into Laparoscopic Pancreatoduodenectomy (LPD) group or Open Pancreatoduodenectomy (OPD) group.

The details of surgery, blood loss, operating time, conversion if any as well as details of postoperative events, hospital stay \& complications if any will be recorded in proforma. Protocols for adjuvant therapy according to pathological stages will be followed. These patients will be reviewed at 1, 3 and 6 months post-surgery.

The primary outcome will be hospital stay at time of discharge or death. The secondary outcomes will be Blood Loss, Operating Time, Complications and pathological radicality at discharge or death. The trial is expected to last for a duration of 2 years.

Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT)

A Prospective Randomized Controlled Trial Comparing Laparoscopic Versus Open Pancreatoduodenectomy for Malignant Periampullary and Pancreatic Head Lesions

Two specimen arms will be compared on the basis of extent of pathological clearance like margin positivity rate, number of lymph nodes, average length of surgical margin

Pancreatic surgery specific complications will be accessed by International Study group for pancreatic surgery ( ISGPS) classification like post operative pancreatic fistula ( POPF). Other complications will be accessed by Clavien Dindo Classification system

GEM Hospital & Research Center

Gastrointestinal Agents

Pancrelipase

Pancreatin

puncture of head of pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control.

randomization: puncture with either 22G needle or 19G flex needle

puncture of head of pancreas

CHRISTIAN BOUSTIERE, MD

The purpose of this study is to compare the diagnostic gain between 22G standard needle vs 19G Flex needles transduodenal punctures of masses of the pancreatic head.

The negative predictive value of fine needle aspiration under ultrasound endoscopy (EUS-FNA) for the diagnosis of solid pancreatic masses is about 70 - 80 % with the 22G standard needle. Pancreatic adenocarcinoma is known to have a severe prognosis and a low rate of survival even after curative surgery. The study of pancreatic solid tumors is one the main diagnostic problem present in the investigators daily practice. In most of non operated patients, EUS-FNA is the sole possibility to confirm the diagnosis of malignancy which is required to initiate chemotherapy and/or radiotherapy. To improve the performances of the EUS-FNA, new needles are now disposable either with a cutting window design (EchoTip ProCore-COOK Medical) or flexible 19G needle (19G Expect Flex - Boston-Scientific). The goal is to obtain more tissue material with the possibility of a histologic study without increasing the risk of the puncture which is very low (complications rate \< 1%). The problem concerns the lesion of the head of the pancreas requiring a trans-duodenal access for the puncture . In this position, the needle is very difficult to push out the operator channel and, in some cases, the puncture is quite impossible with stiff needles as "ProCore" or standard 19G. Thus, the interest of flexible 19G needle is to be used in difficult technical cases as transduodenal access for head pancreatic tumors, with a good safety and more efficacy than 22G needles.

Comparison of Two Needles (19G Flex Versus 22G Standard) for Pancreatic Solid Tumors Diagnosis

Randomized, Comparative Study of 19G Flex Versus 22G Standard Needles for Pancreatic Solid Tumors Diagnosis.

accuracy and diagnostic gain of fine needle aspiration under ultrasound endoscopy (EUS-FNA) for the diagnosis of solid pancreatic tumors of the head of pancreas: comparison between 19G Flex and 22G standard needles punctures.

immediate per-procedure complications and delayed morbidity (up to day 30) side effects resulting of technical failure or dysfunction of the puncture ease of handling for the two needles (visual analogic scale)

quality of histological specimens obtained with the 2 types of needles (visual analogic scale)

French Society of Digestive Endoscopy

MD, Head of Endoscopy Department, Hôpital Saint Joseph, Marseille

Efficacy of laying of a biliary stent for chemotherapy realization

Type WallFlex or Evolution biliary, stent system

Jean-Luc RAOUL, MD, PHD

For many years, the treatment of jaundice due to head pancreatic adenocarcinoma is based on the endoscopic biliary stent. This technique has been shown to be preferable to a surgical shunt.

Recently, adjuvant chemotherapy with FOLFIRINOX regimen (clinical trial) has revolutionized the treatment of metastatic pancreatic adenocarcinoma increasing overall survival in a major way. This design will also be developed in patients with neoadjuvant tumor called "borderline" (the limit of the resectability).

However, several conditions (protocol) are required to consider the implementation of this design : age ≤ 75 years, PS 0 or 1, good hematological parameters and bilirubin ≤ 1.5 times the ULN.

In addition, a randomized study showed that preoperative biliary stent treatment, despite a success rate of 94%, is associated with more complications than surgery fast (related gesture bladder).

It would be interesting to analyze, prospectively, the fate of a series of patients with cancer of the pancreatic head with compression of the lower part of the bile duct, PS 0 or 1 and for which the only limit to FOLFIRINOX design is jaundice or high risk of jaundice.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Folfirinox Followed by Capecitabine and Limited Field Radiation for Localized Pancreatic Head Adenocarcinoma	NCT01677988	Adenocarcinoma ...	Neo-adjuvant Ch... Chemoradiation Surgical Resect...	18 Years - 80 Years	Medical University of South Carolina
Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT)	NCT02081131	Adenocarcinoma ... Cholangio Carci... Duodenal Adenoc... Carcinoma of Am...	Open surgery Laparoscopic su...	30 Years - 70 Years	GEM Hospital & Research Center
Comparison of Two Needles (19G Flex Versus 22G Standard) for Pancreatic Solid Tumors Diagnosis	NCT02078232	Adenocarcinoma ...	puncture of hea... puncture of hea...	18 Years -	French Society of Digestive Endoscopy
Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas	NCT02487836	Adenocarcinoma ...	Type WallFlex o...	18 Years - 75 Years	Institut Paoli-Calmettes
Trial Evaluating the Efficacy of Laying a Biliary Stent for Producing a Heavy Chemotherapy in Unresectable Pancreatic Adenocarcinomas	NCT02487836	Adenocarcinoma ...	Type WallFlex o...	18 Years - 75 Years	Institut Paoli-Calmettes

Spots Global Cancer Trial Database for adenocarcinoma of head of pancreas