Colorectal Cancer MetastaticPhase 2NCT03251612
Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer
A Phase 2 study testing Based on sensitivity analysis in people with Colorectal Cancer Metastatic, run by Vejle Hospital at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Based on sensitivity analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 22 Sep 2017to 21 Mar 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Denmark3 sites
Department of Oncology, Aalborg University Hospital
Aalborg
Department of Oncology, Rigshospitalet
Copenhagen
Departmen of Oncology, Vejle Hospital
Vejle
Germany1 site
Universitätsklinikum Hamburg - Eppendorf, Universitäres Cancer Center Hamburg (UCCH)
Hamburg
About this study
Official title: 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.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Based on sensitivity analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Based on sensitivity analysisDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | 1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis. Receives: Drug: Based on sensitivity analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival 8 weeks after start of treatment
Measured: 42-63 days after start of treatment
Secondary outcomes (4)
Progression free survival
Measured: Every 8 weeks until progression or death up to 2.5 years
Overall survival
Measured: Every 3 months up to 2.5 years
Response rate
Measured: Every 8 weeks until progression up to 2.5 years
Quality of life as measured by questionnaire EQ-5D-5L
Measured: Every 8 weeks up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start22 Sep 2017
- Primary completion23 Aug 2021
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars H Jensen, MD, Study chair, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251612
- Sponsor's protocol ID
- Tumorspheres Colrec
- Status last verified
- Jan 2023
- First submitted
- 11 Aug 2017
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jensen LH, Rogatto SR, Lindebjerg J, Havelund B, Abildgaard C, do Canto LM, Vagn-Hansen C, Dam C, Rafaelsen S, Hansen TF. Precision medicine applied to metastatic colorectal cancer using tumor-derived organoids and in-vitro sensitivity testing: a phase 2, single-center, open-label, and non-comparative study. J Exp Clin Cancer Res. 2023 May 5;42(1):115. doi: 10.1186/s13046-023-02683-4.
PubMed 37143108
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of In-vitro Testing Anti-cancer Therapy Sensitivity on Tumorspheres From Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03251612
- Acronym / sponsor ID
- Tumorspheres Colrec
- Conditions
- Colorectal Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 22 Sep 2017 (actual)
- Primary completion
- 23 Aug 2021 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Drug: Based on sensitivity analysis1 drug or a combination of drugs considered standard anticancer treatment is given according to the result of the sensitivity analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Metastatic colorectal cancer
- Previously exposed to or intolerance or contraindications to standard systemic therapy, defined as
- Progressive disease defined as progression according to RECIST 1.1
- ECOG performance status 0-2
- Age at least 18 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Treatment |
Primary outcome
Progression free survival 8 weeks after start of treatment
Time frame: 42-63 days after start of treatment
4 secondary outcomes
Progression free survival
Time frame: Every 8 weeks until progression or death up to 2.5 years
Overall survival
Time frame: Every 3 months up to 2.5 years
Response rate
Time frame: Every 8 weeks until progression up to 2.5 years
Quality of life as measured by questionnaire EQ-5D-5L
Time frame: Every 8 weeks up to 2.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 37143108Jensen LH, Rogatto SR, Lindebjerg J, Havelund B, Abildgaard C, do Canto LM, Vagn-Hansen C, Dam C, Rafaelsen S, Hansen TF. Precision medicine applied to metastatic colorectal cancer using tumor-derived organoids and in-vitro sensitivity testing: a phase 2, single-center, open-label, and non-comparative study. J Exp Clin Cancer Res. 2023 May 5;42(1):115. doi: 10.1186/s13046-023-02683-4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars H Jensen, MD study chair
Vejle Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Based on sensitivity analysis in people with Colorectal Cancer Metastatic, run by Vejle Hospital at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival 8 weeks after start of treatment (time frame: 42-63 days after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03251612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.