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Phase II Chemoradiation Trial Using Gemcitabine in Patients With Locoregional Adenocarcinoma of the Pancreas

Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

Phase II Chemoradiation Trial Using Gemcitabine in Patients With Locoregional Adenocarcinoma of the Pancreas

OBJECTIVES: I. Estimate time to progression and overall survival of patients with
locoregional adenocarcinoma of the pancreas treated with gemcitabine combined with radiation
therapy. II. Estimate the biomarker response to this regimen through evaluation of
circulating CA19-9 levels and correlate this response with survival of this patient

OUTLINE: Patients receive radiation therapy 5 days per week for 5 1/2 weeks and gemcitabine
IV over 30 minutes not greater than 2 hours prior to radiation therapy twice weekly. This
combination radiation therapy and chemotherapy is followed by 2 weeks of rest. Patients with
stable or responding disease receive a higher dose of gemcitabine IV over 30 minutes weekly
for 3 weeks followed by 1 week of rest. This 4 week course is repeated 3 more times for a
total of 16 weeks of gemcitabine therapy alone. Patients are followed every 2 months for the
first year and then every 3 months for the next 2 years or until disease progression. Upon
documentation of disease progression, patients are followed every 3 months for survival and
secondary malignancy.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 24 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the pancreas
Locoregional and not amenable to surgery based on 1 or more of the following: Size of
pancreatic tumor greater than 5 cm Lymph nodes bulky, greater than 2 cm, but within
radiation port Vascular involvement or impingement of major vessels (e.g., superior
mesenteric artery, superior mesenteric vein, portal vein, hepatic artery) Involvement of
colon (head lesions) or involvement of adrenal, kidney, or colon (tail lesions) Patients
must be registered and begin treatment within 42 days of surgical staging No metastatic
disease or nodal disease outside of radiation port documented by CT scan or MRI and chest

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Albumin greater than 3 g/dL Bilirubin less than 2.0 mg/dL Renal:
Creatinine less than 2.0 mg/dL Calcium normal Other: No prior or concurrent malignancy
within the past 5 years except inactive nonmelanoma skin cancer, carcinoma in situ of the
cervix, or other curatively treated cancers Not pregnant or nursing Negative pregnancy
test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for carcinoma of the
pancreas Chemotherapy: No prior chemotherapy for carcinoma of the pancreas No other
concurrent chemotherapy Endocrine therapy: No prior endocrine therapy for carcinoma of the
pancreas No concurrent hormone therapy (except for nondisease-related conditions)
Radiotherapy: No prior radiation therapy for carcinoma of the pancreas No prior abdominal
radiation therapy Surgery: See Disease Characteristics No prior surgery for carcinoma of
the pancreas

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Principal Investigator

Margaret A. Tempero, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




Start Date:

September 1998

Completion Date:

January 2006

Related Keywords:

  • Pancreatic Cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • adenocarcinoma of the pancreas
  • Adenocarcinoma
  • Pancreatic Neoplasms



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