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Phase II Study of Oxaliplatin, Continuous 5-Fluorouracil and External Beam Radiation Followed by Gemcitabine in Patients With Locally Advanced Pancreatic Cancer

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Pancreas, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer

Thank you

Trial Information

Phase II Study of Oxaliplatin, Continuous 5-Fluorouracil and External Beam Radiation Followed by Gemcitabine in Patients With Locally Advanced Pancreatic Cancer


I. Determine the 1-year survival rate in patients with locally advanced, unresectable
adenocarcinoma of the pancreas treated with concurrent external beam radiotherapy,
oxaliplatin, and fluorouracil followed by gemcitabine.


I. Determine overall survival, time to disease progression, and confirmed response rate in
patients treated with this regimen.

II. Determine toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning
concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15,
and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the
completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1
and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of
disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the pancreas

- Unresectable disease, including subtotal resection and gross residual disease

- Locally advanced disease

- No cystadenocarcinoma of the pancreas

- No pancreatic tumors of neuroendocrine origin

- No microscopic residual disease as only evidence of pancreatic cancer

- All disease must be encompassable within standard radiotherapy fields for pancreatic

- No distant metastases (liver or lung metastases or peritoneal spread)

- No evidence of metastatic disease outside the planned radiotherapy field

- Performance status - ECOG 0-1

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9.0 g/dL

- Bilirubin ≤ 2 times upper limit of normal (ULN)

- AST ≤ 3 times ULN

- Creatinine ≤ 1.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to maintain adequate oral nutrition

- No significant infection

- No significant nausea or vomiting

- No other medical condition that would preclude study participation

- No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma
in situ of the cervix, or organ-confined prostate cancer (Gleason score < 7)

- No known allergy to platinum compounds

- No prior biologic therapy

- No concurrent biologic therapy

- No concurrent immunotherapy

- No prior chemotherapy

- No other concurrent chemotherapy

- No prior radiotherapy that would overlap planned radiotherapy fields

- No other concurrent radiotherapy

- See Disease Characteristics

- At least 21 days since prior laparotomy

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1-year survival rate

Outcome Description:

1-year survival will be considered "success". The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. If more than 1 patients is lost to follow-up, we will use Kaplan-Meier estimates for the 6-month and 12-month overall survival rates. 95% confidence intervals for the true success proportion will be calculated according the approach of Duffy and Santner.

Outcome Time Frame:

At 1 year

Safety Issue:


Principal Investigator

George Kim

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group


United States: Food and Drug Administration

Study ID:




Start Date:

December 2004

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Stage II Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



North Central Cancer Treatment Group Rochester, Minnesota  55905