A Phase II Randomized Study of Induction Chemotherapy Followed by Concurrent Chemo-radiotherapy in Locally Advanced Pancreatic Cancer
20 Years
75 Years
Both
Locally Advanced Pancreatic Cancer
Trial Information
A Phase II Randomized Study of Induction Chemotherapy Followed by Concurrent Chemo-radiotherapy in Locally Advanced Pancreatic Cancer
Patients should be randomized to two study arms stratified by resectability status
(borderline resectable and unresectable) after enrollment. Eligible patients will be
randomly assigned on a 1:1 basis to either of two study groups, using a central
randomization procedure with stratification according to NCCN criteria of resectability.
After randomization, induction chemotherapy (ICT) will be administered for 3 cycles ( 3
months). Patients who have radiological evidence of distant dissemination will be shifted to
salvage chemotherapy. Patients who have responsive, stable disease as well as those with
localized progressive disease after ICT will receive concurrent chemoradiotherapy (CCRT) 3-4
weeks after the last dose of ICT. Surgical evaluation will be performed 4-6 weeks after the
completion of CCRT. Patients who have respectable disease will undergo surgical resection.
Postoperative adjuvant chemotherapy for 3 cycles ( 3 months) will be given for those who are
considered to have curative resection. Patients who still have unresectable disease or
non-curative resection will receive systemic chemotherapy till disease progression or
unacceptable toxicity.
For Arm 1, ICT with gemcitabine ( fixed rate of 10mg/m2/min, 1000mg/m2 on day 1,8,15 every
28 days/cycle) will be administered on a 3-week-on-one-week-off weekly basis. For Arm 2, ICT
with GOFL ( 800mg/m2 gemcitabine at a fixed rate of 10mg/m2/min followed by a 2-hour
oxaliplatin 85mg/m2 and then a 48-hour 3000mg/m2 5-FU and 150 mg/m2 leucovorin on day 1 and
15 every 28 days/cycle) will be given biweekly.
After three 3 cycles of ICT, patients without distant metastasis will be given CCRT with
gemcitabine 400mg/m2 2 hrs before RT on day1,8,15,22,29,36. Radiation will be given 180cGy
per day, 5 days a week for 28 fractions to totally 5040cGy.
If complete surgical resection is feasible, optimal surgery will be performed 4-6 weeks
after CCRT. If complete surgical resection is impossible, biopsy with or without bypass
surgery may be performed. Patients who have curative surgical resection will receive
additional 6 cycles ( 6 months) of adjuvant chemotherapy ( Arm1, gemcitabine alone; Arm 2,
GOFL) within 4 weeks after surgery and then followed up until tumor progression. Patients
who are not feasible for curative resection, will receive continued chemotherapy (Arm1,
gemcitabine alone; Arm2, GOFL) 3-4 weeks after CCRT complete. The regimen will continue till
disease progression.
Inclusion Criteria:
1. Patients must have histologically or cytologically confirmed adenocarcinoma of the
exocrine pancreas.
2. Patients must have locally advanced pancreatic cancer (LAPC).
3. Patients must have LAPC evaluated by radiologist and/or surgeon according to either
abdominal CT or MRI, or intra-operative findings.
4. Patients must have measurable disease.
5. Age >20 years.
6. ECOG performance scale of 0-2.
7. Patients must have normal organ and marrow function.
8. Patients who present with jaundice, temporary or permanent internal / external
drainage before enrollment will be allowed.
9. The effects of study agents on the developing human fetus at the recommended
therapeutic dose are unknown. Women of child-bearing potential and men must agree to
use adequate contraception (hormonal or barrier method of birth control; abstinence)
prior to study entry and for the duration of study participation.
10. Ability to understand and the willingness to sign a written informed consent
document.
Exclusion Criteria:
1. Patients with distant metastases are not eligible.
2. Patients may not be receiving any other investigational agents.
3. Patients who have had prior chemotherapy or radiotherapy are not eligible.
4. History of allergic reactions attributed to compounds of similar chemical or biologic
composition to study agents used in the study.
5. Patients who have above grade II peripheral neuropathy.
6. Patients who had non-curable second primary malignancy.
7. Uncontrolled intercurrent illness including.
8. Pregnant women are excluded from this study because the study agents has the
potential for teratogenic or abortifacient effects.
9. Those who are immuno-compromised or receiving immuno-suppressive therapy are excluded
from the study.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary end point is to evaluate the time to progression after gemcitabine alone versus Gemcitabine-based combination induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer.
Outcome Time Frame:
6 months
Safety Issue:
Yes
Principal Investigator
Pin-Wen Lin, M.D
Investigator Role:
Study Chair
Investigator Affiliation:
National Cheng-Kung University Hospital
Authority:
Taiwan: Department of Health
Study ID:
T2209
NCT ID:
NCT01063192
Start Date:
November 2009
Completion Date:
September 2016
Related Keywords:
- Locally Advanced Pancreatic Cancer
- Locally Advanced Pancreatic Cancer
- Pancreatic Neoplasms
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