Stereotactic Radiation Therapy And Combination Chemotherapy In Treating Patients Undergoing Surgery For Locally Advanced Pancreatic Cancer

Study Overview

Stereotactic Radiation Therapy and Combination Chemotherapy in Treating Patients Undergoing Surgery for Locally Advanced Pancreatic Cancer

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving stereotactic radiation therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving stereotactic radiation therapy together with combination chemotherapy works in treating patients undergoing surgery for locally advanced pancreatic cancer.

OBJECTIVES: Primary * Determine the clinical response rate in patients undergoing surgery for locally advanced pancreatic cancer treated with stereotactic radiotherapy, gemcitabine hydrochloride, and oxaliplatin. Secondary * Determine the toxicity of this regimen in these patients. * Determine the time to disease progression in patients treated with this regimen. * Determine the time to death in patients treated with this regimen. * Determine perioperative morbidity and mortality in patients treated with this regimen. * Determine the rate of R0 resections in patients treated with this regimen. * Determine the histologic response rate in these patients. OUTLINE: * Neoadjuvant therapy: Patients undergo hypofractionated, stereotactic radiotherapy on days 1-5. Patients also receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 120 minutes on day 2. Treatment with gemcitabine hydrocloride and oxaliplatin repeats every 2 weeks for 3 courses. * Surgery: Patients with resectable disease undergo tumor resection. Patients with unresectable disease undergo a second course of neoadjuvant chemoradiotherapy followed by resection. * Adjuvant therapy: Beginning 3-4 weeks after surgery, patients receive 3 more courses of chemotherapy as in neoadjuvant therapy. After completion of study treatment, patients are followed every 3 months for up to 2 years. PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.

Pancreatic Cancer

DRUG: gemcitabine hydrochloride
DRUG: oxaliplatin
PROCEDURE: adjuvant therapy
PROCEDURE: neoadjuvant therapy
RADIATION: hypofractionated radiation therapy
RADIATION: stereotactic radiosurgery

CDR0000515934
KRDI-TUM-STRATEGIE-STR-242-LOR
EU-20659

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-01-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-12-11
First Submitted that Met QC Criteria 2007-01-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-12-12
First Posted (ESTIMATED) 2007-01-23	Results First Posted N/A	Last Verified 2012-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Clinical response rate as assessed by RECIST criteria

Secondary Outcome Measures	Measure Description	Time Frame
Toxicity as assessed by NCI-CTC criteria
Time to progression
Time to death
Perioperative morbidity and mortality
Rate of R0 resections
Histologic response rate

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed adenocarcinoma of the pancreas or intrapancreatic bile duct carcinoma

Overall view of image morphology and CA19-9 (< 500 U/L) demonstrating pancreatic cancer allowed if histologic/cytologic confirmation is unavailable
Locally advanced disease, meeting 1 of the following criteria:

Uncertain R0 resectability dependant on relation to portal vein, sinus confluens, superior mesenteric artery, and superior mesenteric vein (e.g., contact with portal vein, superior mesenteric vein, or arterial vessels, but < 180° encasement)
Unresectable pancreatic cancer (e.g., contact with portal vein, superior mesenteric artery or arterial vessels, > 180° encasement)
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 1 cm by spiral CT scan or MRI

Patients with no measurable disease may be assessed for feasibility only
No distant metastases

ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100%
WBC ≥ 3,000/mm³
Granulocyte count ≥ 2,000/mm³
Platelet count ≥ 100,000/mm³
Creatinine clearance > 30 mL/min
Bilirubin ≤ 3.0 times upper limit of normal
AST and ALT ≤ 2.5 times normal
Alkaline phosphatase ≤ 2.5 times normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No secondary malignancy within the past 5 years that was not curatively treated
No known intolerance to any of the study drugs
No preexisting polyneuropathy > grade 1
No active uncontrolled infection
No cardiac insufficiency despite optimal medication
No New York Heart Association class III or IV congestive heart failure
LVEF ≥ 50% OR shortening fraction ≥ 25%
No angina pectoris (at rest or under stress) unexplained by interventional cardiology within the past 6 months
No myocardial infarction within the past 6 months
No uncontrolled diabetes mellitus
No other existing serious medical impairments that would preclude study compliance

No prior chemotherapy
No prior radiotherapy to the abdomen

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Florian Lordick, MD, Technical University of Munich

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record