Adjuvant Gemcitabine and Capecitabine Chemotherapy in Resected Pancreatic Cancer Following Neoadjuvant Chemotherapy
Withdrawn before enrolling · Phase 2
Conditions studied: Pancreatic Cancer
In brief
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.
Key facts
- Study ID
- NCT05415917
- Run by
- Rutgers, The State University of New Jersey
- People needed
- 0
- Starts
- 2022-07-29
- Expected to finish
- 2024-08-05
- Last updated by the study team
- 2026-05-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
Full record on ClinicalTrials.gov
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