Chemotherapy and Radiation Therapy Before Surgery Followed by Gemcitabine in Treating Patients with Pancreatic Cancer

Conditions

• Acinar Cell Adenocarcinoma of the Pancreas
• Duct Cell Adenocarcinoma of the Pancreas
• Recurrent Pancreatic Cancer
• Stage II Pancreatic Cancer
• Stage III Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• oxaliplatin — DRUG
  IV
• irinotecan — DRUG
  IV
• leucovorin — DRUG
  IV
• 5-fluorouracil — DRUG
  IV
• capecitabine — DRUG
  PO
• radiation — RADIATION
• surgery — PROCEDURE
• gemcitabine — DRUG
  IV

Study Details

This pilot clinical trial studies combination chemotherapy and radiation therapy before surgery followed by gemcitabine hydrochloride in treating patients with pancreatic cancer. Drugs used in chemotherapy, such as oxaliplatin, irinotecan hydrochloride, leucovorin calcium, fluorouracil, and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.

Key Dates

Start date

May 29, 2013

Status verified

Jan 2025

Primary completion

Nov 1, 2014

Completion

Jun 15, 2018

Study Design

Enrollment

23 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: mFOLFIRINOX, chemoradiation, surgery and gemcitabine
  Each patient will receive mFOLFIRINOX therapy administered every other week for a total of 4 cycles. Each treatment cycle is a total of 14 days. This treatment program consists of four drugs (oxaliplatin 85 mg/m\^2 IV over 2 hours on day 1 followed by irinotecan 180 mg/m\^2 IV over 90 minutes on day 1 followed by, leucovorin 400 mg/m\^2 IV over 2 hours on day 1 followed by 5-FU 2400 mg/m\^2 IV over 46-48 hours). Two to six weeks following treatment with the mFOLFIRINOX, if the tumor has not spread to other parts of the body then the patient will receive capecitabine 825 mg/m\^2, twice daily for 28 days along with radiation therapy. Patients will have surgery within 4-10 weeks of the last dose of chemoradiation if the tumor has gotten smaller or stayed the same. Within 6-8 weeks following surgery, patients will receive gemcitabine for 2 cycles (1 cycle is 28 days). Gemcitabine will be given IV on days 1, 8 and 15 of every 28 day cycle.

Primary Outcome Measure

Accrual rate, calculated by total number of patients accrued divided by number of months from the date the study is opened at the fifth site to the evaluation date [ Time Frame: Up to 3 years ]

Locations (14)

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