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Predictive Value of Analysing Tissue From Patients With Metastatic Pancreatic Cancer for Drug Sensitivity (TIP)

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ClinicalTrials.gov Identifier: NCT03821870
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital

Brief Summary:

It will be investigated whether it is possible to predict the effect or lack of effect of first-line treatment by analysing cancer cells from the individual patient receiving standard first line treatment. Also, the feasibility of selecting second-line therapy based on pre-treatment biopsies will be investigated.

Cells from pancreatic cancer will be grown in the laboratory to form small, circulating tumors and adjacent tissue, so called tumoroids. The tumoroids will then be exposed to different pre-specified anticancer drugs to hopefully reveal sensitivity or lack of sensitivity in the specific patient.


Condition or disease Intervention/treatment
Metastatic Pancreatic Cancer Diagnostic Test: Inditreat Drug: Experimental drug

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Value of In-vitro Anti-cancer Therapy Sensitivity Testing on Tumoroids From Patients With Metastatic Pancreatic Cancer
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Standard treatment
Standard first line treatment
Diagnostic Test: Inditreat
Tumoroid formation and drug sensitivity analysis

Drug: Experimental drug
Second line treatment based on drug sensitivity analysis




Primary Outcome Measures :
  1. Predictive value of in-vitro testing [ Time Frame: 2 months ]
    Predictive value is defined as the ability to correctly predict response or resistance to first-line chemotherapy


Secondary Outcome Measures :
  1. Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by treatment response (RESIST 1.1 criteria) [ Time Frame: Every 2 months during treatment up to 180 days ]
  2. Feasibility of selecting second-line therapy based on pre-treatment biopsies as measured by progression free survival (PFS) [ Time Frame: Every 2 months up to 12 months ]

Biospecimen Retention:   Samples With DNA
Liver biopsy and blood samples


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with metastatic pancreatic cancer eligible for chemotherapy
Criteria

Inclusion Criteria:

  • Non-resectable pancreatic cancer

    • Biopsy proven adenocarcinoma compatible with pancreatic origin (primary tumor or metastasis)
    • If only biopsy from metastasis can be obtained, the patient must have a previously resected or image proven tumor of the pancreas
    • Deemed non-resectable at a multidisciplinary conference
  • Candidate to standard systemic therapy, defined as one of

    • Gemcitabine monotherapy,
    • Gemcitabine and nab-paclitaxel combination,
    • Gemcitabine and capecitabine combination,
    • 5-fluorouracil, oxaliplatin and irinotecan combination (FOLFIRINOX), or
    • New standard treatments approved by the multidisciplinary cancer group 'Danish Pancreatic Cancer Group' in the inclusion period.
  • Measurable disease according to RECIST 1.1
  • ECOG performance status 0-2
  • Age at least 18 years
  • Adequate bone marrow, liver and renal function allowing systemic chemotherapy

    • Absolute neutrophil count ≥1.5x10^9/l and thrombocytes ≥ 100x10^9/l
    • Bilirubin ≤ 3 x upper normal value and alanine aminotransferase ≤ 5 x upper normal value
    • Calculated or measured renal glomerular filtration rate at least 30 mL/min
  • Contraception for fertile women and for male patients with a fertile partner. Intrauterine device, vasectomy of a female subject's male partner or hormonal contraceptive are acceptable
  • Written and orally informed consent

Exclusion Criteria:

  • Potentially resectable disease

    • Incapacity, frailty, disability, or comorbidity to a degree that according to the investigator is not compatible with participation in the protocol
    • Other active malignant disease requiring therapy
    • Other systemic anti-cancer therapy (palliative radiotherapy is allowed)
    • Pregnant (positive pregnancy test) or breast feeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821870


Contacts
Contact: Lars Henrik Jensen, MD, PhD +45 7940 6802 lars.henrik.jensen@rsyd.dk

Locations
Denmark
Departmen of Oncology, Vejle Hospital Recruiting
Vejle, Denmark
Contact: Lars H Jensen, MD       lars.henrik.jensen@rsyd.dk   
Sponsors and Collaborators
Vejle Hospital
Investigators
Study Chair: Lars Henrik Jensen, MD, PhD Vejle Hospital

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT03821870     History of Changes
Other Study ID Numbers: TIP
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases