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 range18 Years
SexALL
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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…
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