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TERMINATEDPHASE2

Gemcitabine and Capecitabine With or Without T-ChOS as Adjuvant Therapy for Patients With Resected Pancreatic Cancer

A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Gemcitabine (GEM) and Capecitabine (CAP) With or Without T-ChOS as Adjuvant Therapy in Patients With Surgically Resected Pancreatic Cancer.

NCT02767752•Herlev Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent
•2. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors are excluded
•3. Subject should be able to start treatment no later than 12 weeks post-surgery
•4. Male or non-pregnant, non-lactating females who are ≥18 years of age at the time of signing the informed consent form (ICF)
•5. ECOG/WHO Performance Status (PS) 0-1
•6. 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:
•* Agree to the use of two physician-approved contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study IP; and for 3months following the last dose of IP
•* Has negative serum pregnancy test (β-hCG) result at screening
•7. 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
+10 more criteria

Exclusion Criteria

•1. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma
•2. Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma
•3. 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
•4. 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:
•* Active infection requiring antibiotics within 2 weeks before the study inclusion
•* Concurrent congestive heart failure NYHA class III - IV
•* Unstable angina pectoris, or myocardial infarction within 6 months and/or prior poorly controlled hypertension
•* History of interstitial lung disease, slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis or multiple allergies
•* Concomitant use of immunosuppressive or myelosuppressive medications that would in the opinion of the investigator, increase the risk of serious neutropenic complications
•5. Known or suspected allergy to the investigational agents or any agents given in association with this trial
+6 more criteria

Locations (1)

Department of Oncology

Herlev, Denmark

Key Dates

Start Date

November 1, 2016

Primary Completion Date

July 1, 2018

Completion Date

July 1, 2018

Last Updated

July 10, 2018

Enrollment

ACTUAL participants

Conditions

Pancreatic Cancer

Interventions

T-ChOS

DIETARY_SUPPLEMENT

Gemcitabine

DRUG

Placebo

DIETARY_SUPPLEMENT

Capecitabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Gemcitabine and Capecitabine With or Without T-ChOS as Adjuvant Therapy for Patients With Resected Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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