Status and phase
Conditions
Treatments
About
This is a single center, randomized, double-blind, placebo-controlled phase II trial that will compare the efficacy of T-ChOS in combination with gemcitabine to gemcitabine alone as adjuvant treatment for 6 months in patients with surgically resected pancreatic adenocarcinoma.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Signed informed consent
Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded
Subject should be able to start treatment no later than 12 weeks post-surgery
Male or non-pregnant, non-lactating females who are ≥18 years of age at the time of signing the informed consent form (ICF)
ECOG/WHO Performance Status (PS) 0-1
Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:
Male subjects:
• Must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following IP discontinuation, even if he has undergone a successful vasectomy
Understand and voluntarily sign an ICF prior to any study related assessments or procedures being conducted
Be able to adhere to the study visit schedule and other protocol requirements
Acceptable hematology parameters defined as:
Acceptable liver function defined as:
Acceptable renal function with a creatinine clearance ≥ 50 mL/min/ (e.g., using the Cockroft-Gault formula)
Exclusion criteria
Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma
Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma
Other malignancies, except adequately treated basal carcinoma or squamous cell carcinoma of the skin or in situ cervix carcinoma or incidental prostate cancer (T1a, Gleason score ≤ 6, PSA < 0.5 ng/ml), or any other tumor with a DSF survival of ≥ 5 years
History of serious or concurrent illness or uncontrolled medical disorder; any medical condition that might be aggravated by chemotherapy treatment or which could not be controlled; including, but not restricted to:
Known or suspected allergy to the investigational agents or any agents given in association with this trial
Any psychological, familial, sociological, or geographical condition which does not permit protocol compliance and medical follow-up
Enrollment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures
Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
Any condition that confounds the ability to interpret data from the study
Unwillingness or inability to comply with study procedures
Current use of anticoagulation therapy such as heparins both unfractionated and low molecular weighted
Primary purpose
Allocation
Interventional model
Masking
21 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal