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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01821612
Other study ID # A021101
Secondary ID U10CA031946
Status Completed
Phase Early Phase 1
First received
Last updated
Start date May 2013
Est. completion date June 15, 2018

Study information

Verified date August 2018
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot clinical trial studies combination chemotherapy and radiation therapy before surgery followed by gemcitabine hydrochloride in treating patients with pancreatic cancer. Drugs used in chemotherapy, such as oxaliplatin, irinotecan hydrochloride, leucovorin calcium, fluorouracil, and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.


Description:

The purpose of this study is to evaluate a new treatment program for patients with borderline resectable pancreas cancer in order to determine what effects, good and bad, chemotherapy and chemoradiation have on your cancer and to see if it allows safe surgery.

Primary Objectives:

- To assess the accrual rate of this study.

- To assess the rate of treatment-related toxicity and treatment delay during preoperative therapy.

- To assess the rate of completion of all preoperative and operative therapy.

Secondary Objectives:

- To assess the macroscopic (R0/R1) resection rate.

- To estimate the rate of radiographic and histopathologic response to preoperative therapy.

- To estimate the time to locoregional and distant recurrence.

- To assess overall survival (OS).

- To retrieve nucleic acids from pretreatment pancreatic ductal adenocarcinoma biopsies and to assess the quality of these nucleic acids using a sequencing-based assessment of tumor DNA.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date June 15, 2018
Est. primary completion date September 5, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Pre-Registration Eligibility Criteria

- Documentation of Disease and Radiographic Staging

- Cytologic or histologic proof of adenocarcinoma of the pancreatic head or uncinate process

- Objective radiographic staging with a) contrast-enhanced, helical thin-cut computed tomography (CT)/magnetic resonance imaging (MRI) scan of the abdomen and b) CT scan/MRI of the chest

- Note: echoendoscopic staging will be permitted as an adjunctive modality, but all stage definitions below will be determined using CT/MRI as outlined below. In the event echoendoscopic stage and CT/MRI stage are discordant, the CT/MRI stage will be used. Significant discordance should be discussed with the study principal investigator (PI) prior to enrollment

- Borderline resectable primary tumor, defined by the presence of any one or more of the following on CT/MRI, and confirmed by central radiographic review:

- An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring = 180 degrees of the circumference of the vessel wall

- Short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction

- Short segment interface (of any degree) between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and reconstruction

- An interface between the tumor and superior mesenteric artery (SMA) measuring < 180 degrees of the circumference of the vessel wall

- No potentially resectable disease defined as primary tumors with all of the following:

- An interface between the primary tumor and the superior mesenteric vein or portal vein (SMV-PV) measuring < 180 degrees of the circumference of the vessel wall

- No radiographic interface between the tumor and the (superior mesenteric artery) SMA, hepatic artery or celiac axis

- No radiographic evidence of metastatic disease

- No metastatic disease defined as any one or more of the following:

- Suspicious lymphadenopathy outside the standard surgical field (i.e., aortocaval nodes, distant abdominal nodes)

- Radiographic evidence for metastatic disease in distant organs, such as masses in distant organs or ascites

- No locally advanced and/or unresectable disease clearly defined by any one or more of the following by CT/MRI:

- An interface between the tumor and the SMA measuring = 180 degrees of the circumference of the vessel wall

- No interface between the tumor and the aorta

- Occlusion of the SMV or portal vein without a sufficient cuff of normal vein above and below the level of obstruction with which to perform venous reconstruction

- Long-segment interface (of any degree) between the tumor and the common hepatic artery or its major tributaries with insufficient artery proximal and distal to the interface to perform reconstruction

- No prior chemotherapy or chemoradiation for pancreatic cancer

- No patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for = 3 years

- Baseline peripheral sensory neuropathy must be grade < 2

- No patients with known Gilbert's Syndrome or homozygosity for UGT1A1*28 polymorphism

- No history of pulmonary embolism in the past 6 months

- Age = 18 years of age

- Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0-1

- Pregnancy/Nursing Status: Non-pregnant and non-breast-feeding. Female participants of child-bearing potential must have a negative urine or serum pregnancy test prior to registration. Perimenopausal participants must be amenorrheic > 12 months to be considered not of childbearing potential.

- Required Pre-Registration Laboratory Values:

- Granulocytes = 2,000/ul

- Hemoglobin > 9 g/dL

- Platelets = 100,000/ul

- Albumin > 3.0 g/dL

- Creatinine =1.5 x upper limit of normal (ULN)

Registration Eligibility Criteria

- Confirmation of pre-registration eligibility criteria as described under "Documentation of Disease and Radiographic Staging" by the Alliance Central Radiographic Review

- Required Registration Laboratory Values:

- Bilirubin =2 mg/dl

- AST (SGOT) & ALT (SGPT) = 2.5 x ULN

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
oxaliplatin
IV
irinotecan
IV
leucovorin
IV
5-fluorouracil
IV
capecitabine
PO
Radiation:
radiation

Procedure:
surgery

Drug:
gemcitabine
IV

Locations

Country Name City State
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States University of Cincinnati Cincinnati Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States M D Anderson Cancer Center Houston Texas
United States UC San Diego Moores Cancer Center La Jolla California
United States The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States University Pointe West Chester Ohio
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accrual rate, calculated by total number of patients accrued divided by number of months from the date the study is opened at the fifth site to the evaluation date Up to 3 years
Primary Rate of treatment-related toxicity during preoperative therapy assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4 Up to 30 days after completion of study treatment
Primary Rate of treatment delay (greater than 4 weeks) during preoperative therapy Up to 28 weeks
Primary Completion rate of all preoperative and operative therapy Up to 30 weeks
Secondary Macroscopic (R0/R1) resection rate defined as number of patients achieved R0 or R1 resection during surgery divided by number of evaluable patients At the time of surgery
Secondary Radiographic response rate defined as number of patients who achieved complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 during pre-operative therapy divided by the number of evaluable patients Up to 18 weeks
Secondary Histopathologic response rate defined as number of patients who achieved CR or PR determined according to histopathologic examination during pre-operative therapy divided by the number of evaluable patients Up to 18 weeks
Secondary Time to locoregional recurrence From the date of registration to the date of the first documented locoregional recurrence, assessed up to 3 years
Secondary Time to distant recurrence From the date of registration to the date of the first documented distant recurrence, assessed up to 3 years
Secondary Overall survival From the date of registration to the date of the death due to all causes, assessed up to 3 years
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