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Xenotransplantation of Primary Cancer Samples in Zebrafish Embryos (xenoZ)

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ClinicalTrials.gov Identifier: NCT03668418
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
Azienda Ospedaliero, Universitaria Pisana
Information provided by (Responsible Party):
Luca Morelli, University of Pisa

Brief Summary:
The study consists in a co-clinical trial by using zebrafish embryos. Specifically, an observational prospective clinical trial on patients operated of epato-biliar-pancreatic cancers and gastro-intestinal cancers undergoing a chemotherapy treatment will be run concurrently to an animal trial on zebrafish embryos xenotransplanted with patient cancer cells in order to demonstrate that zebrafish model is able to predict the therapeutic regimen with the best efficacy for each patient.

Condition or disease Intervention/treatment
Liver Cancer Pancreatic Cancer Gastric Cancer Esophageal Cancer Colo-rectal Cancer Gall Bladder Cancer Biliary Tract Cancer Drug: Fluorouracil Drug: Lederfolin Drug: Oxaliplatin Drug: Irinotecan Drug: Docetaxel Drug: Cisplatin Drug: Epirubicin Drug: Gemcitabine Drug: Nab paclitaxel

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Xenotransplantation of Primary Cancer Samples in Zebrafish Embryos
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2022


Group/Cohort Intervention/treatment
Colorectal cancer
Patients operated for colorectal cancer with or without liver metastasis undergoing a chemotherapy treatment after surgery
Drug: Fluorouracil
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Fluoropyrimidine

Drug: Lederfolin
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Antimetabolite

Drug: Oxaliplatin
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Platinum compounds

Drug: Irinotecan
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Camptothecin

Esophagus/gastric cancer
Patients operated for esophagus/gastric cancer undergoing a chemotherapy treatment after surgery
Drug: Fluorouracil
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Fluoropyrimidine

Drug: Lederfolin
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Antimetabolite

Drug: Oxaliplatin
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Platinum compounds

Drug: Irinotecan
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Camptothecin

Drug: Docetaxel
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Taxane

Drug: Cisplatin
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Platinum compounds

Drug: Epirubicin
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Anthracycline

Biliary duct cancer
Patients operated for biliary duct cancer undergoing a chemotherapy treatment after surgery
Drug: Fluorouracil
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Fluoropyrimidine

Drug: Lederfolin
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Antimetabolite

Drug: Oxaliplatin
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Platinum compounds

Drug: Cisplatin
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Platinum compounds

Drug: Gemcitabine
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Antimetabolite

Pancreatic cancer
Patients operated for pancreatic cancer undergoing a chemotherapy treatment after surgery
Drug: Fluorouracil
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Fluoropyrimidine

Drug: Lederfolin
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Antimetabolite

Drug: Oxaliplatin
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Platinum compounds

Drug: Irinotecan
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Camptothecin

Drug: Gemcitabine
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Antimetabolite

Drug: Nab paclitaxel
The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
Other Name: Taxane




Primary Outcome Measures :
  1. Correspondence with chemo-sensitivity data collected in zebrafish model [ Time Frame: 18 months after the surgery ]
    Comparative evaluation between prospectively collected data on clinical outcome and chemo-sensitivity data collected in zebrafish model


Secondary Outcome Measures :
  1. Response rate [ Time Frame: 3 months after the surgery ]
    • Complete response (CR) — complete disappearance of clinical evidence of a tumour. Radiographically equivocal lesions must remain stable or regress.
    • Partial response (PR) — 50% or greater decrease in the sum of products of the longest perpendicular diameters of measured lesion compared to baseline.
    • Stable disease (SD) — no significant change in disease status. Lesion may show a <50% decrease in sum of products of longest perpendicular diameters or an increase of <25%.
    • Progressive disease (PD) — a 25% increase in area of a lesion. Appearance of new lesions constitutes progressive disease.

  2. Overall survival [ Time Frame: 3 months after the surgery ]
    The length of time from the start of treatment for the cancer that patients diagnosed with the disease are still alive

  3. Time to tumour progression [ Time Frame: 3 months after the surgery ]
    The length of time from the date of start of treatment for the disease until the disease starts to get worse or spread to other parts of the body

  4. Response rate [ Time Frame: 6 months after the surgery ]
    • Complete response (CR) — complete disappearance of clinical evidence of a tumour. Radiographically equivocal lesions must remain stable or regress.
    • Partial response (PR) — 50% or greater decrease in the sum of products of the longest perpendicular diameters of measured lesion compared to baseline.
    • Stable disease (SD) — no significant change in disease status. Lesion may show a <50% decrease in sum of products of longest perpendicular diameters or an increase of <25%.
    • Progressive disease (PD) — a 25% increase in area of a lesion. Appearance of new lesions constitutes progressive disease.

  5. Overall survival [ Time Frame: 6 months after the surgery ]
    The length of time from the start of treatment for the cancer that patients diagnosed with the disease are still alive

  6. Time to tumour progression [ Time Frame: 6 months after the surgery ]
    The length of time from the date of start of treatment for the disease until the disease starts to get worse or spread to other parts of the body

  7. Response rate [ Time Frame: 12 months after the surgery ]
    • Complete response (CR) — complete disappearance of clinical evidence of a tumour. Radiographically equivocal lesions must remain stable or regress.
    • Partial response (PR) — 50% or greater decrease in the sum of products of the longest perpendicular diameters of measured lesion compared to baseline.
    • Stable disease (SD) — no significant change in disease status. Lesion may show a <50% decrease in sum of products of longest perpendicular diameters or an increase of <25%.
    • Progressive disease (PD) — a 25% increase in area of a lesion. Appearance of new lesions constitutes progressive disease.

  8. Overall survival [ Time Frame: 12 months after the surgery ]
    The length of time from the start of treatment for the cancer that patients diagnosed with the disease are still alive

  9. Time to tumour progression [ Time Frame: 12 months after the surgery ]
    The length of time from the date of start of treatment for the disease until the disease starts to get worse or spread to other parts of the body

  10. Response rate [ Time Frame: 18 months after the surgery ]
    • Complete response (CR) — complete disappearance of clinical evidence of a tumour. Radiographically equivocal lesions must remain stable or regress.
    • Partial response (PR) — 50% or greater decrease in the sum of products of the longest perpendicular diameters of measured lesion compared to baseline.
    • Stable disease (SD) — no significant change in disease status. Lesion may show a <50% decrease in sum of products of longest perpendicular diameters or an increase of <25%.
    • Progressive disease (PD) — a 25% increase in area of a lesion. Appearance of new lesions constitutes progressive disease.

  11. Overall survival [ Time Frame: 18 months after the surgery ]
    The length of time from the start of treatment for the cancer that patients diagnosed with the disease are still alive

  12. Time to tumour progression [ Time Frame: 18 months after the surgery ]
    The length of time from the date of start of treatment for the disease until the disease starts to get worse or spread to other parts of the body



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Oncological patients from Azienda Ospedaliero-Universitaria Pisana
Criteria

Inclusion Criteria:

- patients operated of epato-biliar-pancreatic cancers and gastro-intestinal cancers (stage III and IV) undergoing a chemotherapy treatment

Exclusion Criteria:

  • age below 18 years
  • significant co-morbid cardiovascular and respiratory disease
  • early stage of disease, (iv) history of prior cancer or prior treatment with any chemotherapy regimen
  • pregnant and lactating females
  • patients requiring urgent/ emergency interventions
  • life expectancy < 12 weeks

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): NCT03668418


Contacts
Contact: Luca Morelli, Prof 050996820 ext 0039 luca.morelli@unipi.it

Locations
Italy
Azienda Ospedaliero-Universitaria Pisana Recruiting
Pisa, Italy, 56124
Contact: Luca Morelli, Prof       luca.morelli@unipi.it   
Sub-Investigator: Vittoria Raffa, Prof         
Sub-Investigator: Enrico Vasile, Dr         
Sub-Investigator: Gregorio Di Franco, MD         
Sub-Investigator: Alice Usai, MSc         
Sponsors and Collaborators
University of Pisa
Azienda Ospedaliero, Universitaria Pisana
Investigators
Principal Investigator: Luca Morelli, Prof University of Pisa

Responsible Party: Luca Morelli, Principal Investigator, University of Pisa
ClinicalTrials.gov Identifier: NCT03668418     History of Changes
Other Study ID Numbers: 70213
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Urinary Bladder Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Biliary Tract Neoplasms
Colorectal Neoplasms
Gallbladder Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Gastrointestinal Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Head and Neck Neoplasms
Intestinal Neoplasms
Gallbladder Diseases
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Stomach Diseases
Urologic Diseases
Esophageal Diseases
Liver Diseases
Biliary Tract Diseases
Colonic Diseases
Intestinal Diseases