Gemcitabine and Capecitabine for Pancreatic Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pancreatic CancerGemcitabine and Capecitabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Pancreatic Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Five Years

Five Years
Safety as assessed by number of participants experiencing adverse events
To measure the tumor with the Response Evaluation Criteria in Solid Tumors (RECIST)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Group 2 - Observational
1 of 2
Group 1- Gemcitabine and Capecitabine Treatment
1 of 2

Active Control

Experimental Treatment

75 Total Participants · 2 Treatment Groups

Primary Treatment: Gemcitabine and Capecitabine · No Placebo Group · Phase 2

Group 1- Gemcitabine and Capecitabine Treatment
Drug
Experimental Group · 1 Intervention: Gemcitabine and Capecitabine · Intervention Types: Drug
Group 2 - ObservationalNoIntervention Group · 1 Intervention: Group 2 - Observational · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: five years

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
376 Previous Clinical Trials
58,553 Total Patients Enrolled
Prateek Gulhati, MD, PhDPrincipal InvestigatorRutgers Cancer Institute of New Jersey

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a histologically and/or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma.
You are at least 18 years old.
You have a performance status of 0 - 2.
Neoadjuvant chemotherapy (for at least three months) +/- chemoradiation followed by R0 surgical resection.
You have a hemoglobin level of at least 8 g/dL.
Platelets > 75,000 / μL.\n
Total bilirubin ≤1.5 ULN.