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Adjuvant Gemcitabine and Capecitabine Chemotherapy in Resected Pancreatic Cancer Following Neoadjuvant Chemotherapy

NCT05415917 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-05-07

No results posted yet for this study

Summary

Primary Objectives:

To determine the disease free survival (DFS) for participants treated with post-operative adjuvant chemotherapy, as compared to neoadjuvant therapy alone.

Secondary Objectives:

To determine the clinical efficacy of the study treatment in terms of median overall survival (OS) and median disease free survival (DFS).

To assess the safety and tolerability of the study treatment regimen as measured by the adverse events rates.

To assess the quality of life in patients receiving the study treatment.

Conditions

Interventions

DRUG

Gemcitabine and Capecitabine

A chemotherapy cycle will constitute 28 days of treatment: 1. Gemcitabine: 1000 mg/m2 IV on days 1, 8, and 15 of each 28-day cycle 2. Capecitabine: 1660 mg/m2 per day orally on days 1 through 21 of each 28-day cycle.

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Prateek Gulhati, MD, PhD · Rutgers Cancer Institute of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-29
Primary Completion
2024-08-05
Completion
2024-08-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05415917 on ClinicalTrials.gov