A Multi-Center Randomized Phase II Study of Induction Chemotherapy Followed by Gemcitabine or Capecitabine Based Chemoradiotherapy for Locally Advanced Non-Metastatic Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Multi-Center Randomized Phase II Study of Induction Chemotherapy Followed by Gemcitabine or Capecitabine Based Chemoradiotherapy for Locally Advanced Non-Metastatic Pancreatic Cancer
OBJECTIVES:
- To evaluate the activity, safety, and feasibility of induction chemotherapy comprising
gemcitabine and capecitabine followed by two different schedules of chemoradiotherapy
comprising gemcitabine or capecitabine and radiotherapy in patients with locally
advanced, nonmetastatic, unresectable pancreatic cancer.
- To determine which of the two experimental arms gives the highest generic and
disease-specific aspects of health-related quality of life (HRQL) following treatment.
- To determine how HRQL varies during treatment and follow up in both arms.
OUTLINE: This is a multicenter study.
All patients receive a first induction therapy comprising gemcitabine IV on days 1, 8, and
15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 3
courses in the absence of disease progression or unacceptable toxicity. Following the first
induction therapy, patients with a WHO performance status of 0-1 who are responding or have
stable disease that can be encompassed within a radically treatable radiotherapy volume are
randomized to 1 of 2 treatment arms.
- Arm I:
- Second induction therapy (weeks 13-16): Patients receive gemcitabine IV once daily
on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21.
- Chemoradiotherapy (weeks 17-22): Patients receive gemcitabine IV once weekly on
day 1 and undergo conformal radiotherapy 5 days a week for 5.5 weeks.
- Arm II:
- Second induction therapy (weeks 13-16): Patients receive gemcitabine IV once daily
on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21.
- Chemoradiotherapy (weeks 17-22): Patients receive oral capecitabine twice daily on
days 1-5 and undergo conformal radiotherapy 5 days a week for 5.5 weeks.
Patients complete quality-of-life questionnaires QLQ-C30 and PAN26 at baseline and at 17,
23, 26, 39, and 52 weeks.
After completion of study treatment, patients are followed every 3 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Locally advanced, nonmetastatic, inoperable, or operable (but medically unfit
for surgery) disease
- Palliative bypass procedure allowed
- Common bile duct stenting allowed
- Primary pancreatic lesion ≤ 7 cm in diameter as measured by CT scan of the thorax and
abdomen within 4 weeks prior to registration
- No recurrent cancer following definitive pancreatic surgery
PATIENT CHARACTERISTICS:
- WHO performance status (PS) 0-2
- Neutrophil count ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 10 g/dL
- Serum bilirubin < 35 μmol/L (50 μmol/L allowed for patients who have had a recent
biliary drain and whose bilirubin is descending)
- AST/ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN
- GFR > 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 weeks after
completion of study therapy
- No evidence of severe uncontrolled systemic diseases including uncontrolled coronary
artery disease
- No myocardial infarction or stroke within the past 6 months
- No prior malignancies within the past 5 years except for carcinoma in situ of the
cervix, adequately treated basal cell skin carcinoma, or any early-stage malignancy
- No suspected DPD deficiency
- No renal abnormalities (e.g., adult polycystic kidney disease, hydronephrosis, or
ipsilateral single kidney)
- Must meet the following additional criteria for randomization:
- WHO PS 0-1
- Loss of weight no greater than 10% of that at baseline
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior and no concurrent sorivudine or analogues
- No prior radiotherapy to the upper abdomen
- No concurrent methotrexate
- No concurrent allopurinol
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival at 39 weeks (from registration) according to RECIST criteria
Safety Issue:
No
Principal Investigator
Somnath Mukherjee
Investigator Role:
Principal Investigator
Investigator Affiliation:
Northampton General Hospital
Authority:
Unspecified
Study ID:
CDR0000660755
NCT ID:
NCT01032057
Start Date:
July 2009
Completion Date:
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage II pancreatic cancer
- stage III pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|
