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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00335543
First received: June 8, 2006
Last updated: August 9, 2013
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Median survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 3-year survival rate [ Designated as safety issue: No ]
  • R0 resection rate [ Designated as safety issue: No ]
  • Rate of medium and high toxicity events [ Designated as safety issue: Yes ]
  • Rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies [ Designated as safety issue: No ]
  • Rate of different regression gradings in resected tumor specimens [ Designated as safety issue: No ]
  • Quality of life before, during, and after therapy [ Designated as safety issue: No ]

Estimated Enrollment: 254
Study Start Date: June 2003
Study Completion Date: October 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335543

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00335543     History of Changes
Other Study ID Numbers: IAGTDK-70-3046-Ho2, CDR0000472206, EU-20609, ISRCTN78805636
Study First Received: June 8, 2006
Last Updated: August 9, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014