Testing the Use of the Usual Chemotherapy Before and After Surgery for Removable Pancreatic Cancer

Conditions

• Pancreatic Adenosquamous Carcinoma
• Pancreatic Cancer
• Resectable Pancreatic Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Oxaliplatin — DRUG
  Given IV
• Irinotecan Hydrochloride — DRUG
  Given IV
• Leucovorin Calcium — DRUG
  Given IV
• Fluorouracil — DRUG
  Given IV
• Resection — PROCEDURE
  Undergo surgical resection
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

Key Dates

Start date

Oct 13, 2020

Status verified

Feb 2026

Primary completion

Dec 31, 2028

Completion

Nov 1, 2030

Study Design

Enrollment

358 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (perioperative chemotherapy, surgery)
  Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Within 2-8 weeks of completing neoadjuvant chemotherapy, patients undergo surgical resection. Patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
• Active Comparator: Arm II (surgery, adjuvant chemotherapy)
  Patients undergo surgical resection. Beginning 3-12 weeks after surgery, patients then receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-3. Treatment repeats every 14 days for 12 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Time between randomization and death from any cause, assessed up to 6 years. ]

Locations (441)

Find similar trials in Birmingham, AL

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