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A Randomized Phase III Study of Adjuvant Gemcitabine Versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer Underwent Curative Intent (R0 / R1) Resection

Phase 3
20 Years
75 Years
Open (Enrolling by invite only)
Pancreatic Cancer

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Trial Information

A Randomized Phase III Study of Adjuvant Gemcitabine Versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer Underwent Curative Intent (R0 / R1) Resection

Treatment plan and Randomization scheme::

Patients will be randomized after stratification according to pathology report on section
margin, tumor size, lymph node metastasis:

Patients who are randomized to Arm 1 will receive adjuvant chemotherapy started within 4-8
weeks after the surgery, and administered at D1, D8 and D15 every 4 weeks for 6 cycles (6
months). Patients who are allocated to Arm 2 will receive sandwich treatment, which
comprised of the same adjuvant chemotherapy within 4-8 weeks after the surgery for 3 cycles
(3 months), followed by CCRT (start 4-6 weeks after the last dose of 3rd cycle chemotherapy)
and then another 3 cycles of gemcitabine monotherapy.

Statistical Consideration:

We anticipate the 2-year disease free survival will increase from 25% to 40% with the
incorporation of CCRT into the adjuvant treatment for post-operative pancreatic
adenocarcinoma. With a significant level of 0.05, 107 patients will be required for each
treatment arm to reach 80% statistical power. Since the drop out rate is approximately 10%,
265 patients will be enrolled to ensure that we will have 214 (107x2) eligible patients in
this study. We anticipate that we will recruit roughly 67 patients per year, therefore,
patient recruitment will be completed in 4 years.

Randomization scheme:

Histo-/cyto-logically confirmed macroscopic complete resected pancreatic adenocarcinoma

1. The primary end-point is disease free survival.

2. The secondary end-points are overall survival; local and distant control rate, and the
quality of life.

3. The clinical and molecular prognostic factors for overall survival.

- Radiation fields encompass initial main tumor of pancreas only with a safe margin
of 1cm. Lymph node regions initially involved with tumor confirmed by excision
will be included in the clinical target volume. Elective radiation to uninvolved
lymph nodes will not be given.

Inclusion Criteria

A.Eligibility Criteria

1. Patients with pancreatic cancer after curative intent resection.

2. The histology of resected tumor has to be adenocarcinoma.

3. Age 20-75 years.

4. ECOG performance scale 0-1.

5. Patients must have normal organ and marrow function as defined below.

6. The effects of study agents on the developing human fetus at the recommended
therapeutic dose are unknown.

7. to sign a written informed consent.

8. Registered within 6 weeks after surgery.

9. Preoperative abdominal CT or MRI with contrast enhancement.

B.Exclusion Criteria

1. Patients with gross residual, macroscopic positive resection margin or distant

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.

5. Patients who had non-curable second primary malignancy.

6. Uncontrolled intercurrent illness including.

7. Pregnant women.

8. receiving immuno-suppressive therapy、anti-coagulants.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

The primary end-point is recurrence-free survival.

Outcome Time Frame:

Pancreatic Cancer Disease Committee

Safety Issue:


Principal Investigator

Tsann-Long Hwang, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Chang Gung Memorial Hospital


Taiwan: Department of Health

Study ID:




Start Date:

February 2009

Completion Date:

January 2015

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Pancreatic Neoplasms