Adjuvant Gemcitabine and Capecitabine Chemotherapy in Resected Pancreatic Cancer Following Neoadj… (NCT05415917) | Clinical Trial Compass
WithdrawnPhase 2
Adjuvant Gemcitabine and Capecitabine Chemotherapy in Resected Pancreatic Cancer Following Neoadjuvant Chemotherapy
Stopped: No patients enrolled
United States0Started 2022-07-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Exclusion Criteria:
* 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 activ…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety as assessed by number of participants experiencing adverse events
Timeframe: Five Years
Trial details
NCT IDNCT05415917
SponsorRutgers, The State University of New Jersey