RECRUITING

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

Conditions

Pancreatic Cancer Gemcitabine Chemotherapy Capecitabine Chemotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-07-29

Study Completion:2025-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05415917

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologically and/or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma * Neoadjuvant chemotherapy (for at least three months) ± chemoradiation followed by R0 surgical resection * Eastern Cooperative Oncology Group(ECOG) Performance status of PS 0 - 2 * At least 18 years of age * Adequate bone marrow and organ functions as defined by: * Absolute neutrophil count ≥ 1000 cells/ μL * Hemoglobin ≥ 8 g/ dL * Platelets \> 75,000 / μL * Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 30 mL/min by Cockroft-Gault * Total bilirubin ≤1.5 ULN * AST/ ALT \< 2.5 x ULN, unless with liver metastases and then must be \<5 x ULN of normal * Women and men of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect pregnancy on study, she must notify her treating physician immediately * Ability to understand the nature of this study protocol and give written informed consent. * Willingness and ability to comply with scheduled visits, treatment plans laboratory tests and other study procedures	* Receipt of any investigational agents at the time of registration * Known, untreated brain metastases * Presence of metastatic disease or malignant ascites on diagnostic imaging * Grade two or greater peripheral neuropathy * Presence of any additional active malignancy within the past 3 years where the malignancy is at least reasonably likely to later the course of therapy, require systemic therapy or interfere with imaging assessments * Uncontrolled intercurrent illness, including significant active infection, symptomatic congestive heart failure (NYHA classification grade III or IV), unstable angina or active arrhythmia * Major surgery within the 4 weeks prior to initiation of study treatment * A history of allergy or hypersensitivity to any of the study drugs * Any additional significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from fully participating in the study * Pregnancy * Severe hepatic impairment * Participants with known malabsorption

Inclusion Criteria

Exclusion Criteria

* Histologically and/or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma
* Neoadjuvant chemotherapy (for at least three months) ± chemoradiation followed by R0 surgical resection
* Eastern Cooperative Oncology Group(ECOG) Performance status of PS 0 - 2
* At least 18 years of age
* Adequate bone marrow and organ functions as defined by:
* Absolute neutrophil count ≥ 1000 cells/ μL
* Hemoglobin ≥ 8 g/ dL
* Platelets \> 75,000 / μL
* Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 30 mL/min by Cockroft-Gault
* Total bilirubin ≤1.5 ULN
* AST/ ALT \< 2.5 x ULN, unless with liver metastases and then must be \<5 x ULN of normal
* Women and men of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect pregnancy on study, she must notify her treating physician immediately
* Ability to understand the nature of this study protocol and give written informed consent.
* Willingness and ability to comply with scheduled visits, treatment plans laboratory tests and other study procedures

* Receipt of any investigational agents at the time of registration
* Known, untreated brain metastases
* Presence of metastatic disease or malignant ascites on diagnostic imaging
* Grade two or greater peripheral neuropathy
* Presence of any additional active malignancy within the past 3 years where the malignancy is at least reasonably likely to later the course of therapy, require systemic therapy or interfere with imaging assessments
* Uncontrolled intercurrent illness, including significant active infection, symptomatic congestive heart failure (NYHA classification grade III or IV), unstable angina or active arrhythmia
* Major surgery within the 4 weeks prior to initiation of study treatment
* A history of allergy or hypersensitivity to any of the study drugs
* Any additional significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from fully participating in the study
* Pregnancy
* Severe hepatic impairment
* Participants with known malabsorption

Contacts and Locations

Study Contact

Prateek Gulhati, MD, PhD

CONTACT

732-235-2465

pat.gulhati@rutgers.edu

Howard S Hochster, MD

CONTACT

732-235-2465

howard.hochster@rutgers.edu

Principal Investigator

Prateek Gulhati, MD, PhD

PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Study Locations (Sites)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Prateek Gulhati, MD, PhD, PRINCIPAL_INVESTIGATOR, Rutgers Cancer Institute of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-29

Study Completion Date2025-03-01

Study Record Updates

Study Start Date2022-07-29

Study Completion Date2025-03-01

Terms related to this study

Keywords Provided by Researchers

Gemcitabine Chemotherapy
Capecitabine Chemotherapy

Additional Relevant MeSH Terms

Pancreatic Cancer