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Folfirinox

Patients with unresectable or "borderline resectable" locally advanced pancreatic carcinoma at time of diagnosis

Neoadjuvant stereotactic body radiotherapy (SBRT, 30 Gy in 5 fractions) plus chemotherapy with Folfirinox

SBRT plus chemotherapy

Alessio G Morganti, MD

Evaluation of clinical response in terms of resectability of patients with locally advanced pancreatic cancer treated with neoadjuvant chemotherapy plus stereotactic body radiotherapy.

Aim of the study is to define the percentage of patients with down-staging and clinical response after having undergone stereotactic radiotherapy + chemotherapy with neoadjuvant intent for locally advanced pancreatic carcinoma or "borderline resectable" at the time of diagnosis.

The study evaluates the response to therapy in terms of resectability, of acute and delayed treatment-related toxicity, of overall survival and progression-free survival and also assesses patient's quality of life.

Improving REsectability in Pancreatic NEoplasms (IRENE)

Interventional Multicentric Study Without Medicine, in Patients Affected by Locally Advanced Pancreatic Adenocarcinoma: Stereotactic Radiotherapy.

Percentage of patients with pancreatic cancer judged to be inoperable who have undergone surgical treatment after neoadjuvant chemotherapy plus stereotactic body radiotherapy. Response is evaluated with CT-scan and 18F FDG PET-scan (RECIST criteria) by a multidisciplinary team of surgeons, radiologist, oncologist, radiation oncologist according to resectability criteria NCCN v. 2017.

Progression-free survival (PFS) after radiotherapy is evaluated with CT-scan and 18F FDG PET-scan (RECIST criteria). Also laboratory tests are performed (CA 19.9)

Acute and late toxicities after radiotherapy are assessed with CTCAE v. 4.03

QoL are assessed with Cancer Linear Analog Scale (CLAS) which evaluating well-being, fatigue, and ability to perform daily activities (values range from 0 that represents the best status to 10 that represents the worst one)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Professor

Symptoms and General Pathology

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Hematinics

Liver Extracts

The patients with secondary resectable colorectal hepatic metastasis undergoing surgery

The patients with secondary resectable colorectal hepatic metastasis who underwent continuous chemotherapy

Hepatic resection

Jin-Tung Liang, PhD

The role of surgical resection in the subset of patients with resectable hepatic metastases converted from initially non-resectable liver metastasis was still not clearly established. To further explore the oncologic results of surgical versus non-surgical methods for the treatment of this subset of patients, we designed and conducted the present randomized prospective study beginning in 2002. The present study was based on the following arguments against the predominant survival benefits of surgical resection in previous reported series: (1) The initially non-resectable liver metastasis was basically a disseminated disease, even though some metastases were highly responsive to chemotherapy and become resectable; (2) Since the evaluation of resectability was based on the imaging studies, it was difficult to consider the surgical resection as "curative" for the resectable hepatic metastases converted from non-resectable ones, given the limitation of the current imaging stools of high-technology; (3) The resectable hepatic metastases after neoadjuvant chemotherapy might represent a subset of hepatic metastases biologically highly responsive to chemotherapy and the time-to-progression for these metastases might be fairly long after a response. Additionally, these metastases might be also biologically responsive to other cytotoxic or targeted therapies that justified the patients' continuous adoption of non-surgical treatment.

In 2000, de Gramont et al. and Giacchetti et al. reported that combination chemotherapy including modulated infusional 5-Fu plus irinotecan and oxaliplatin could achieve a response rate of approximately 50% and a median survival of in excess of 20 months. These encouraging results implied that chemotherapy is likely to play an increasingly important role in decreasing the size of metastasis to allow for liver resection. Interestingly, Adam and Bismuth et al. reported that the 5-year overall survival of 50% (95% confidence interval 33-68%), observed in patients with resection following neoadjuvant chemotherapy, was comparable to patients with primarily resectable hepatic metastasis as reported by Scheele et al. (39%, 469 patients), Fong et al. (37%, 1001 patients), Nordlinger et al.(28%, 1568 patients), and Fiqueras et al. (36%, 235 patients). Recently, Zelek et al. reported that intravenous and hepatic artery infusion of irinotecan/ 5-fluorouracil/ leucovorin could facilitate complete resection of initially non-resectable hepatic metastases. Pozzo et al. indicated that neoadjuvant treatment of unresectable liver disease with irinotecan/ 5-fluorouracil/ leucovorin enabled a significant portion of patients to undergo surgical resection. Alberts et al. showed that FOLFOX-4 therapy allowed for successful resection of disease in a portion of patients initially not judged to be optimally resectable but with a high recurrence rate after surgery. Masi et al. reported that neoadjuvant approach with irinotecan plus FOLFOX-4 had significant antitumor activity and provided a radical surgical resection of initially unresctable hepatic colorectal metastases with promising median survival of patients. However, most studies published till now are retrospective analyses without a control group or case series with limited patient number and/or short time of follow-up. Therefore, the role of surgical resection in the subset of patients with resectable hepatic metastases converted from initially non-resectable liver metastasis was still not clearly established. To further explore the oncologic results of surgical versus non-surgical methods for the treatment of this subset of patients, we designed and conducted the present randomized prospective study beginning in 2002. The present study was based on the following arguments against the predominant survival benefits of surgical resection in previous reported series: (1) The initially non-resectable liver metastasis was basically a disseminated disease, even though some metastases were highly responsive to chemotherapy and become resectable; (2) Since the evaluation of resectability was based on the imaging studies, it was difficult to consider the surgical resection as "curative" for the resectable hepatic metastases converted from non-resectable ones, given the limitation of the current imaging stools of high-technology; (3) The resectable hepatic metastases after neoadjuvant chemotherapy might represent a subset of hepatic metastases biologically highly responsive to chemotherapy and the time-to-progression for these metastases might be fairly long after a response. Additionally, these metastases might be also biologically responsive to other cytotoxic or targeted therapies that justified the patients' continuous adoption of non-surgical treatment.

Treatment Outcomes of Hepatic Metastasis After FOLFOX-4 Therapy

Oncologic Outcomes of Surgical Versus Non-surgical Methods for the Treatment of Resectable Colorectal Liver-confined Metastases Converted From Initially Non-resectable Metastases by FOLFOX-4 Neoadjuvant Chemotherapy: A Randomized Clinical Trial

National Science Council, Taiwan

National Taiwan University Hospital

Body Weight

Patients with a confirmed pancreatic mass (suspected neoplastic) deemed resectable or borderline resectable on multislice (at least 16 simultaneously acquired slices) pancreatic protocol computed tomography (CT), fit and willing to undergo surgery with a curative (R0) intent.

Mihai Rimbas, MD, PhD

Cristian R Baicus, Professor

Adrian Saftoiu, Professor

Accurate staging of patients with pancreatic cancer is critical to avoid the expense, morbidity, and mortality related to unnecessary surgery. While several tests are available for assessing such patients, consensus has not been achieved on the optimal approach. As a matter of fact, pancreatic cancer staging is discussed controversially due to conflicting evidence and certainly EUS has lost grounds due to improvements in CT technology. Thus, the role of EUS and EUS-guided FNA varies among treatment centers.

The present study is designed to better define the role of EUS in predicting resectability, as compared to high resolution cross-sectional imaging.

Registry procedures:

* HIGH-RESOLUTION PANCREATIC PROTOCOL COMPUTED TOMOGRAPHY (CT) SCAN EXAMINATION: performed on at least 16-section multi-detector row (MD) CT and reviewed using multi-planar reconstructions, with images obtained following the oral administration of water and pancreatic protocol intravenous iopamidol, with images acquired in the pancreatic and portal venous phases of contrast enhancement, reconstructed as thin slice (at 1 mm - pancreatic phase or 2 mm - portal venous phase increments).
* EUS EXAMINATION: performed within 2 weeks of the MDCT, aiming visualization of the pancreas, main surrounding vascular structures, celiac and mediastinal lymph nodes, liver and left adrenal gland, with EUS-FNA performed at the discretion of the investigator/examiner to confirm/exclude metastases and for the confirmation of malignancy in the primary tumor. Patients confirmed by EUS as having distant metastases are to be deferred from the planned surgical intervention.
* SURGICAL INTERVENTION: aiming to provide curative intent (R0) resection.
* HISTOPATHOLOGICAL POSTOPERATIVE STAGING: with evaluation of loco-regional invasiveness and degree of complete surgical resection (R0/R1).
* FOLLOW-UP OF PATIENTS: with phone-calls on an every 6 month basis, for up to 2 years, retaining the following data: survival (or not), date of decease and its direct cause (if applicable), the presence of tumor recurrence (or not).

EUS vs. MDCT in Pancreatic Malignancy

Endoscopic UltraSound in Potentially Resectable PAncreatic Malignancy - Does it Bear the Weight of the Rapidly Evolving Technology of Computer Tomography?

Each imaging test (MDCT and EUS) and findings at or after surgery are to be judged on their ability to provide descriptions of the primary tumor's size, location, relationship to vessels - using the terms abutment (≤180º of contact) and encasement (\>180º of contact), vessel occlusion, variant vascular anatomy, a grade regarding local tumor resectability (resectable, borderline resectable, or locally advanced; R0 or R1 resection), and extent and location of extrapancreatic disease.

Each patient will be monitored for 24 hours after the EUS examination to identify possible early complications of the procedure

Each patient is going to be followed-up for up to 2 years after the surgical intervention an an every-6 month basis, in order to identify events such as death or tumor recurrence.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving REsectability in Pancreatic NEoplasms (IRENE)	NCT03460925	Pancreatic Canc... Stereotactic Bo...	SBRT plus chemo...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Treatment Outcomes of Hepatic Metastasis After FOLFOX-4 Therapy	NCT00610636	Colorectal Canc...	Hepatic resecti...	18 Years - 80 Years	National Taiwan University Hospital
Treatment Outcomes of Hepatic Metastasis After FOLFOX-4 Therapy	NCT00610636	Colorectal Canc...	Hepatic resecti...	18 Years - 80 Years	National Taiwan University Hospital
EUS vs. MDCT in Pancreatic Malignancy	NCT02115022	Resectable Panc...		18 Years -	Clinical Hospital Colentina
EUS vs. MDCT in Pancreatic Malignancy	NCT02115022	Resectable Panc...		18 Years -	Clinical Hospital Colentina
Improving REsectability in Pancreatic NEoplasms (IRENE)	NCT03460925	Pancreatic Canc... Stereotactic Bo...	SBRT plus chemo...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna

Spots Global Cancer Trial Database for resectability