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

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0

Inactive

ClinicalTrials ID:NCT04340141

This study is comparing two approaches to chemotherapy for pancreatic cancer that can be surgically removed. It aims to find out if giving chemotherapy both before and after surgery is more effective than giving it only after surgery.

Patient Parameters

Parameter	Options

Program Overview

This phase III trial is investigating whether giving chemotherapy both before and after surgery (perioperative) is more effective in treating pancreatic cancer that can be removed by surgery, compared to giving chemotherapy only after surgery (adjuvant). The chemotherapy drugs used in this study include fluorouracil, irinotecan, leucovorin, and oxaliplatin, which work by stopping the growth and spread of cancer cells.

Description

Primary Objectives:

To compare the overall survival of patients with removable pancreatic cancer who receive chemotherapy before and after surgery (perioperative) versus those who receive it only after surgery (adjuvant).

Secondary Objectives:

To compare the time patients remain free of cancer after treatment between the two groups.
To compare how long it takes for cancer to return in the area where it started.
To compare how long it takes for cancer to spread to other parts of the body.
To compare the success rate of completely removing the cancer with surgery.
To compare the rate at which cancer becomes non-removable.
To evaluate the complete response rate to chemotherapy before surgery.
To compare the amount and intensity of chemotherapy received by patients in both groups.
To compare the side effects experienced by patients in both groups.
To compare physical functioning and quality of life between the two groups.
To assess how lifestyle factors like diet and exercise affect survival and side effects.
To evaluate the use of imaging techniques to predict treatment outcomes.

Study Design:

Arm I: Patients receive chemotherapy drugs (oxaliplatin, irinotecan, leucovorin, and fluorouracil) before and after surgery. Chemotherapy is given every 14 days for 8 cycles before surgery and 4 cycles after surgery.
Arm II: Patients undergo surgery first, followed by chemotherapy with the same drugs every 14 days for 12 cycles.

After completing the study treatment, patients will be followed up for 6 years.

Eligibility Criteria

Inclusion Criteria

Must have a confirmed diagnosis of pancreatic cancer that can be surgically removed.
Cancer must not have spread to distant organs.
Must be considered a suitable candidate for surgery aimed at curing the cancer.
No previous treatments for pancreatic cancer.
Must not be pregnant or nursing.
Must have good overall health and meet specific blood test criteria.
Must not have certain genetic conditions or be taking specific medications that interfere with the study.

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