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Adjuvant Chemotherapy for Pancreatic Cancer

Phase 2

Recruiting

Led By Prateek Gulhati, MD, PhD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group(ECOG) Performance status of PS 0 - 2

At least 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up five years

Awards & highlights

Study Summary

This trial is testing whether adding chemotherapy after surgery is better than just having neoadjuvant therapy alone for disease free survival. The secondary objectives are to compare overall survival and disease free survival rates, safety and tolerability, and quality of life.

Who is the study for?

This trial is for adults with pancreatic cancer who've had neoadjuvant chemotherapy and surgery to remove the tumor. They should be in fair to good physical condition, have normal blood counts and organ function, and agree to use birth control. People can't join if they're pregnant, have severe liver problems, other active cancers or major illnesses that could interfere with the study.Check my eligibility

What is being tested?

The trial tests whether adding Gemcitabine and Capecitabine chemotherapy after surgery improves disease-free survival compared to just having neoadjuvant therapy before surgery. It also looks at overall survival rates, side effects, and quality of life.See study design

What are the potential side effects?

Possible side effects include nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems; fatigue; liver issues; hand-foot syndrome (redness/numbness); mouth sores.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of the day.

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I am 18 years old or older.

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I've had chemotherapy for 3+ months and surgery to remove my cancer without any visible remains.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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My diagnosis is pancreatic cancer, confirmed by lab tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and five 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

Safety as assessed by number of participants experiencing adverse events

Other outcome measures

To measure the tumor with the Response Evaluation Criteria in Solid Tumors (RECIST)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group 1- Gemcitabine and Capecitabine TreatmentExperimental Treatment1 Intervention

Day 1, Day 8, Day 15 • Gemcitabine infused through a vein over 120 minutes Day 1 - Day 21 • Capecitabine tablets will be taken two times a day; once in the morning and once in the evening. The tablets should not be crushed or split and should be taken with a full glass of water (8 ounces/240 milliliters) within 30 minutes after a meal.

Group II: Group 2 - ObservationalActive Control1 Intervention

Usual therapy used to treat this type of cancer, chemotherapy plus radiation therapy. If cancer returns during observation, there will be offered standard of care therapy. Follow-up visits will be every three months.

0 / 5Eligibility criteria met