Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer
January 17, 2023 updated by: Vejle Hospital
Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aalborg, Denmark
- Department of Oncology, Aalborg University Hospital
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Copenhagen, Denmark
- Department of Oncology, Rigshospitalet
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Vejle, Denmark
- Departmen of Oncology, Vejle Hospital
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Hamburg, Germany
- Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Treatment
1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Progression free survival 8 weeks after start of treatment
Time Frame: 42-63 days after start of treatment
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42-63 days after start of treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Progression free survival
Time Frame: Every 8 weeks until progression or death up to 2.5 years
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Every 8 weeks until progression or death up to 2.5 years
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Overall survival
Time Frame: Every 3 months up to 2.5 years
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Every 3 months up to 2.5 years
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Response rate
Time Frame: Every 8 weeks until progression up to 2.5 years
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Every 8 weeks until progression up to 2.5 years
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Quality of life as measured by questionnaire EQ-5D-5L
Time Frame: Every 8 weeks up to 2.5 years
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Every 8 weeks up to 2.5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Lars H Jensen, MD, Vejle Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 22, 2017
Primary Completion (Actual)
August 23, 2021
Study Completion (Actual)
March 21, 2022
Study Registration Dates
First Submitted
August 11, 2017
First Submitted That Met QC Criteria
August 11, 2017
First Posted (Actual)
August 16, 2017
Study Record Updates
Last Update Posted (Actual)
January 18, 2023
Last Update Submitted That Met QC Criteria
January 17, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tumorspheres Colrec
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.