Gemcitabine, Cisplatin, and Radiation Therapy Followed By Surgery or Surgery Alone in Treating Patients With Localized Pancreatic Cancer That Can Be Removed By Surgery

Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, 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 chemotherapy together with 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. It is not yet know whether giving chemotherapy together with radiation therapy before surgery is more effective than surgery alone in treating pancreatic cancer.

PURPOSE: This randomized phase II trial is studying how well giving gemcitabine and cisplatin together with radiation therapy before surgery works compared to surgery alone in treating patients with localized pancreatic cancer that can be removed by surgery.

Study Overview

Detailed Description

OBJECTIVES:

Primary

  • Determine whether neoadjuvant chemoradiotherapy comprising gemcitabine hydrochloride, cisplatin, and radiotherapy is better than immediate surgery, in terms of median survival, in patients with locally resectable adenocarcinoma of the pancreatic head.

Secondary

  • Compare 3-year survival rate in patients treated with these regimens.
  • Compare R0 resection rate in these patients.
  • Compare the rate of medium and high toxicity events in these patients.
  • Compare the rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies.
  • Compare the rate of different regression gradings in resected tumor specimens.
  • Compare the quality of life of these patients.

OUTLINE: This is a prospective, randomized, controlled, open-label, multicenter study. Patients are stratified according to participating center and staging laparoscopy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 1 hour on days 1, 8, 22, and 29. Patients also undergo radiotherapy to the tumor and surrounding lymph nodes 5 days a week for 5 weeks followed by 3 more doses of radiotherapy directly to the tumor. Approximately 6 weeks after finishing chemoradiotherapy, patients with no evidence of disease progression undergo surgery to remove the tumor.
  • Arm II: Patients undergo surgery to remove the tumor. After surgery, all patients receive adjuvant chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at the end of chemotherapy and before surgery (arm I), and then at 6 weeks, 6 months, 12 months, and 24 months after surgery.

After completion of study treatment, patients are followed every 3 months for 2 years and then at 3 years.

PROJECTED ACCRUAL: A total of 254 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

254

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

      • Innsbruck, Austria, A-6020
        • Innsbruck Universitaetsklinik
      • Vienna, Austria, A-1090
        • Allgemeines Krankenhaus - Universitatskliniken
      • Berlin, Germany, D-13125
        • Robert Roessle Comprehensive Cancer Center - Charite Campus Buch
      • Bochum, Germany, D-44892
        • Knappschaft Krankenhaus
      • Bremen, Germany, D-28239
        • DIAKO Ev. Diakonie Krankenhaus gGmbH
      • Dresden, Germany, D-01008
        • Krankenhaus Dresden - Friedrichstadt
      • Erlangen, Germany, D-91054
        • Universitaet Erlangen
      • Frankfurt, Germany, 60590
        • Arbeitsgruppe Lebermetastasen und Tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie
      • Goeppingen, Germany, D-73035
        • Klinik am Eichert
      • Heidelberg, Germany, D-69120
        • Chirurgische Universitaetsklinik
      • Leipzig, Germany, D-04103
        • Universitaet Leipzig
      • Magdeburg, Germany, D-39130
        • Staedtisches Klinikum Magdeburg
      • Munich, Germany, D-81377
        • Klinikum der Universitaet Muenchen - Grosshadern Campus
      • Nuremberg, Germany, D-90419
        • Klinikum Nuernberg - Klinikum Nord
      • Regensburg, Germany, D-93053
        • Klinikum der Universitaet Regensburg
      • Tuebingen, Germany, D-72076
        • Universitaetsklinikum Tuebingen
      • St. Gallen, Switzerland, CH-9007
        • Kantonsspital - St. Gallen

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the pancreatic head

    • No tumors of the body or tail, as defined by a tumor lying between the left border of the superior mesenteric vein and the left border of the aorta and/or the left border of the aorta and the hilum of the spleen
  • Locally resectable disease by CT scan

    • Major vessels (e.g., portal vein, confluence of mesenteric and splenic vein, superior mesenteric artery, celiac trunk, splenic artery, hepatic artery, or superior mesenteric vein) maximally enclosed ≤ 180° by the tumor
  • No infiltration of extrapancreatic organs except the duodenum
  • No carcinoma of the ampulla of Vater
  • No metastasis
  • No peritoneal carcinoma

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Creatinine clearance > 70 mL/min
  • Creatinine < 1.5 mg/dL
  • Platelet count > 100,000/mm³
  • No liver cirrhosis
  • Not pregnant
  • No New York Heart Association class III or IV heart disease
  • No respiratory insufficiency
  • No grade III or IV cardiac arrhythmias
  • No pathology on EKG
  • No other severe cardiopulmonary disease
  • No HIV infection
  • No other disease that renders the patient unsuitable for one treatment option
  • No other malignancy except nonmelanoma skin cancer, carcinoma in situ of the cervix, or other cancer for which the patient was treated with surgery only and has been in complete remission for ≥ 10 years

PRIOR CONCURRENT THERAPY:

  • At least 3 months since prior participation in another clinical trial
  • No prior or other concurrent treatment for carcinoma of the pancreas

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Median survival

Secondary Outcome Measures

Outcome Measure
3-year survival rate
R0 resection rate
Rate of medium and high toxicity events
Rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies
Rate of different regression gradings in resected tumor specimens
Quality of life before, during, and after therapy

Collaborators and Investigators

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

Investigators

  • Study Chair: W. Hohenberger, MD, Universitaet Erlangen

Publications and helpful links

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

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 Major Dates

Study Start

June 1, 2003

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

June 8, 2006

First Submitted That Met QC Criteria

June 8, 2006

First Posted (ESTIMATE)

June 12, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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