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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00335543
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : August 12, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Pancreatic Cancer Drug: cisplatin Drug: gemcitabine hydrochloride Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 2

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis
Study Start Date : June 2003
Actual Primary Completion Date : June 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Median survival

Secondary Outcome Measures :
  1. 3-year survival rate
  2. R0 resection rate
  3. Rate of medium and high toxicity events
  4. Rate of complete and incomplete remission of the tumor as measured by radiographic imaging studies
  5. Rate of different regression gradings in resected tumor specimens
  6. Quality of life before, during, and after therapy

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00335543

Show Show 17 study locations
Sponsors and Collaborators
Interdisziplinare Arbeitsgruppe Gastrointestinaler Tumore der Deutschen Krebsgesellschaft
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Study Chair: W. Hohenberger, MD Universitaet Erlangen

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00335543    
Other Study ID Numbers: IAGTDK-70-3046-Ho2
CDR0000472206 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: June 12, 2006    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2009
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:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs