Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Preoperative Chemoradiation in Locally Resectable Adenocarcinoma of Pancreatic Head Without Metastasis
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Median survival
Safety Issue:
No
Principal Investigator
W. Hohenberger, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Universitaet Erlangen
Authority:
Unspecified
Study ID:
CDR0000472206
NCT ID:
NCT00335543
Start Date:
June 2003
Completion Date:
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage I pancreatic cancer
- stage II pancreatic cancer
- stage III pancreatic cancer
- Adenocarcinoma
- Pancreatic Neoplasms
Name | Location |
|---|
