Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer

Conditions

• Acinar Cell Adenocarcinoma of the Pancreas
• Duct Cell Adenocarcinoma of the Pancreas
• Stage I Pancreatic Cancer
• Stage IIA Pancreatic Cancer
• Stage IIB Pancreatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• oxaliplatin — DRUG
  Given IV
• leucovorin calcium — DRUG
  Given IV
• irinotecan hydrochloride — DRUG
  Given IV
• fluorouracil — DRUG
  Given IV
• therapeutic conventional surgery — PROCEDURE
  Undergo surgical resection
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

This phase II trial studies how well combination chemotherapy before and after surgery works in treating patients with localized pancreatic cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Key Dates

Start date

Mar 25, 2014

Status verified

Feb 2026

Primary completion

Aug 16, 2022

Completion

Jan 14, 2024

Study Design

Enrollment

46 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (mFOLFIRINOX)
  NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection. ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression Free Survival Rate [ Time Frame: At 12 months ]

Locations (9)

Find similar trials in Fairfield, CT