Gemcitabine Hydrochloride, and Radiation Therapy in Patients With Borderline Resectable Pancreatic Cancer

Part of paid clinical trials in The Bronx, New York.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT01897454
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fluorouracil — DRUG
    Given IV
  • Gemcitabine Hydrochloride — DRUG
    Given IV
  • Intensity-Modulated Radiation Therapy — RADIATION
    Undergo IMRT
  • Irinotecan Hydrochloride — DRUG
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Oxaliplatin — DRUG
    Given IV

Study Details

This phase II trial studies how well combination chemotherapy, gemcitabine hydrochloride, and radiation therapy before surgery works in treating patients with pancreatic cancer that has not spread to other places in the body and can be removed by surgery. Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan hydrochloride, oxaliplatin, and gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Fluorouracil, irinotecan hydrochloride, and gemcitabine hydrochloride may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy and gemcitabine hydrochloride with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Key Dates

Start date
Jan 27, 2012
Status verified
Dec 2023
Primary completion
Nov 1, 2021
Completion
Nov 1, 2021

Study Design

Enrollment
23 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (FOLFIRINOX, IMRT, and gemcitabine hydrochloride)
    CHEMOTHERAPY REGIMEN: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 90 minutes on day 1, and fluorouracil IV over 46 hours on days 1-3. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving disease progression proceed to chemoradiotherapy. CHEMORADIOTHERAPY REGIMEN: Beginning 4-6 weeks after completion of chemotherapy, patients undergo IMRT on 5 consecutive days per week for a total of 28 fractions and receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Treatment continues in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Percentage of Participants Achieving R0 Resection (R0 Resection Rate) [ Time Frame: Up to 30 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical Center-Weiler HospitalThe BronxNew York10461-

Find similar trials in The Bronx, NY

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Montefiore Medical Center-Weiler Hospital· The Bronx, NY

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