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Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT03251612
Recruitment Status : Recruiting
First Posted : August 16, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital

Study Description
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Brief Summary:
The purpose of the present study is to investigate the benefit of anti-cancer therapy administered on the basis of drug sensitivity testing. This concerns colorectal cancer patients who have previously received standard treatment.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Metastatic Drug: Based on sensitivity analysis Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2020

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Arms and Interventions
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Arm Intervention/treatment
Treatment
1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis.
 Drug: Based on sensitivity analysis
  • 5FU, infusional
  • Capecitabine
  • Oxaliplatin (FOLFOX)
  • Irinotecan (FOLFIRI)
  • FOLFOXIRI (triplet)
  • Bevacizumab
  • Panitumumab
  • Cetuximab
  • Regorafenib
  • Tas-102
  • Ramucirumab
  • Aflibercept
  • Pembrolizumab
  • Nivolumab
  • Vinorelbine and capecitabine
  • Sorafenib
  • Gemcitabine and capecitabine
  • Olaparib
  • Epirubicin


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival 8 weeks after start of treatment [ Time Frame: 42-63 days after start of treatment ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: Every 8 weeks until progression or death up to 2.5 years ]
  2. Overall survival [ Time Frame: Every 3 months up to 2.5 years ]
  3. Response rate [ Time Frame: Every 8 weeks until progression up to 2.5 years ]
  4. Quality of life as measured by questionnaire EQ-5D-5L [ Time Frame: Every 8 weeks up to 2.5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic colorectal cancer

    • Biopsy proven adenocarcinoma compatible with colorectal 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 colon or rectum (scanning or endoscopy)
    • Non-resectable metastatic spread

  • Previously exposed to or intolerance or contraindications to standard systemic therapy, defined as

    • oxaliplatin
    • irinotecan
    • 5-fluorouracil (or similar such as capecitabine, S1)
    • VEGF inhibitor bevacizumab
    • EGFR inhibitor panitumumab or cetuximab (if RAS/RAF wt)
  • Progressive disease defined as progression 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 ≤ 1.5 x upper normal value and alanine aminotransferase ≤ 3 x upper normal value
    • Calculated or measured renal glomerular filtration rate at least 30 mL/min
  • Anticonception 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:

  • 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
Contacts and Locations
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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): NCT03251612


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

Locations
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Denmark
Department of Oncology, Aalborg University Hospital Not yet recruiting
Aalborg, Denmark
Contact: Mette Yilmaz, MD       m.yilmaz@rn.dk   
Department of Oncology, Rigshospitalet Not yet recruiting
Copenhagen, Denmark
Contact: Lone N Petersen, MD       Lone.Noergaard.Petersen@regionh.dk   
Departmen of Oncology, Vejle Hospital Recruiting
Vejle, Denmark
Contact: Lars H Jensen, MD       lars.henrik.jensen@rsyd.dk   
Germany
Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH) Not yet recruiting
Hamburg, Germany
Contact: Andreas Block, MD       block@uke.de   
Sponsors and Collaborators
Vejle Hospital
Investigators
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Study Chair: Lars H Jensen, MD Vejle Hospital
More Information
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Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT03251612     History of Changes
Other Study ID Numbers: Tumorspheres Colrec
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

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

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases