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Surgery

Post-Chemotherapy Surgery for Pancreatic Cancer

N/A

Recruiting

Led By Steven R Grossman, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologic or cytologic proof of pancreatic adenocarcinoma

Performance status Eastern Cooperative Oncology Group (ECOG) 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial tests if surgery after chemotherapy can safely treat pancreatic cancer that has spread locally and can't be removed by surgery.

Who is the study for?

Adults with pancreatic adenocarcinoma that's locally advanced and can't be surgically removed. They must have completed at least 4 cycles of specific chemotherapy without the cancer getting worse, have a good performance status, and agree to use contraception. Not for those who've had certain prior treatments or uncontrolled illnesses.Check my eligibility

What is being tested?

The trial is testing if surgery after neoadjuvant chemotherapy (chemo before surgery) can safely remove tumors in patients whose pancreatic cancer has spread nearby but isn't removable by initial surgery.See study design

What are the potential side effects?

Potential side effects include those related to anesthesia and surgical procedures such as pain, infection, bleeding, blood clots, damage to surrounding organs/tissues and complications from pancreas removal like diabetes or digestive problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diagnosis is pancreatic cancer, confirmed by lab tests.

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I am fully active or can carry out light work.

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I've completed at least 4 cycles of specific chemotherapy without my cancer getting worse.

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I am 18 years old or older.

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My cancer is advanced but hasn't spread beyond the primary site and can't be surgically removed.

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My kidney function is within the required range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

R0 resection rate

Secondary outcome measures

Disease-free survival

Overall survival

Time to distant metastases

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (surgical resection)Experimental Treatment9 Interventions

Patients undergo laparoscopy followed by surgical resection with pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy at the discretion of the surgeon within 2-8 weeks following completion of standard of care neoadjuvant chemotherapy regimen. Patients undergo CT and blood sample collection throughout the study and/or MRI during screening. Patients also undergo tissue collection at time of surgical resection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 2

~1700

Laparoscopy

2022

Completed Phase 2

~3610

Surgical Procedure

2020

Completed Phase 2

~160

Computed Tomography

2017

Completed Phase 2

~2720

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Pancreaticoduodenectomy

2013

Completed Phase 1

~3570

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

906 Previous Clinical Trials

1,596,156 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,421 Total Patients Enrolled

Steven R Grossman, MDPrincipal InvestigatorUniversity of Southern California

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for enrolment in this experiment?

"As per clinicaltrials.gov, this medical trial is not currently seeking participants. Initially posted on November 27th 2023 and last modified on the 9th of November that same year, 1310 other studies are actively recruiting patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PROACTIVE: Surgical Resection Outcomes in Locally Advanced and Unresectable Pancreatic Cancer After Neoadjuvant Chemotherapy

2023. "PROACTIVE: Surgical Resection Outcomes in Locally Advanced and Unresectable Pancreatic Cancer After Neoadjuvant Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06132087.