Colorectal Cancer MetastaticPhase 2Toco-CoRNCT04245865
Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer
A Phase 2 study testing Fluorouracil, Calcium folinate and Oxaliplatin in people with Colorectal Cancer Metastatic, run by Vejle Hospital at 1 site in Denmark.
Trial summary
This double blind, randomized phase II trial will investigate whether the addition of tocotrienol will improve the effect and lower the toxicity of standard chemotherapy and bevacizumab. Half of the patients will receive tocotrienol and the other half placebo. 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?
- Fluorouracil, Calcium folinate and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Jun 2020to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Histopathologically verified adenocarcinoma of the colon or rectum
- Metastatic disease
- Planned treatment with FOLFOX or capecitabine combined with bevacizumab
- Evaluable disease according to RECIST 1.1
- Performance status 0-2
- Expected survival ≥ 3 months
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- Patient acceptance to collection of blood samples for translational research
- Age ≥ 18 years
- Contraception during and 6 months after last dose for women of childbearing potential (less than one year amenorrhea and not undergone hysterectomy, bilateral salpingectomy or bilateral oophorectomy) and for male patients with a fertile partner. Hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, or sexual abstinence is accepted.
- Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):
- WBC ≥ 3.0 x 109/l or neutrophils (ANC) ≥ 1.5 x 10^9/l
- Platelet count ≥ 100 x 10^9/l
- Hemoglobin ≥ 6.0 mmol/l
- Serum bilirubin ≤ 2.0 x ULN
- Serum transaminase ≤ 2.5 x ULN
- Serum creatinine ≤ 1.5 ULN
- Urine dipstick for protein ≤ 2+, if the dipstick shows protein ≥ 2+, 24 hour urine testing must be performed and show protein contents ≤ 1g.
- Written and orally informed consent
Who cannot join
- Other active malignant disease within 5 years prior to inclusion in the study.
- Other experimental therapy within 28 days prior to treatment initiation.
- Underlying medical disease not adequately treated.
- Surgery, including open biopsy, within 4 weeks prior to first dose of bevacizumab.
- Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within six months before start of treatment
- Bleeding tumor
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- Pregnant or breastfeeding women
- Fertile patients not willing to use effective methods of contraception during treatment and for six months after end of treatment.
- Hypersensitivity to one or more active substances or auxiliary substances
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer. A Randomized Phase II Marker Trial
This double blind, randomized phase II trial will investigate whether the addition of tocotrienol will improve the effect and lower the toxicity of standard chemotherapy and bevacizumab. Half of the patients will receive tocotrienol and the other half placebo. Treatment is planned for a period of maximum six months and will be discontinued earlier in case of progression or unacceptable toxicity.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Fluorouracil, Calcium folinate, Oxaliplatin, Bevacizumab, Capecitabine
- Keywords
- Colorectal cancer, Tocotrienol, Natural killer cells, Circulating tumor DNA
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluorouracilDrug
2800 mg/m2 iv
Calcium folinateDrug
400 mg/m2 iv
OxaliplatinDrug
85 mg/m2 iv
BevacizumabDrug
5 mg/kg OR 7.5 mg/kg iv
CapecitabineDrug
2000 mg/m2 orally daily for two weeks
TocotrienolDietary supplement
300 mg orally x 3 daily
PlaceboOther
Placebo orally x 3 daily
| Study group | Role | What they receive |
|---|---|---|
| Arm A, standard treatment + tocotrienol | Experimental | Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + tocotrienol OR capecitabine + bevacizumab + tocotrienol Receives: Drug: Fluorouracil; Drug: Calcium folinate; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Capecitabine; Dietary Supplement: Tocotrienol |
| Arm B, standard treatment + placebo | Placebo comparator | Fluorouracil + calcium folinate + oxaliplatin + bevacizumab + placebo OR capecitabine + bevacizumab + placebo Receives: Drug: Fluorouracil; Drug: Calcium folinate; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Capecitabine; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of progression free patients at six months
Measured: Six months after enrollment of the last patient
Secondary outcomes (3)
Time to first serious adverse event according to CTCAE 5.0
CTCAE=Common Terminology Criteria for Adverse Events
Measured: Six months after enrollment of the last patient
Response rate as measured by RECIST 1.1
RECIST=Response evaluation criteria in solid tumors
Measured: Six months after enrollment of the last patient
Overall survival
Measured: 12 months after enrollment of the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start26 Jun 2020
- Primary completion31 Mar 2025
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torben F Hansen, MD, PhD, Study chair, Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04245865
- Sponsor's protocol ID
- Toco-CoR
- Acronym
- Toco-CoR
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2020
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocotrienol and Bevacizumab in Metastatic Colorectal Cancer. A Randomized Phase II Marker Trial
- ClinicalTrials.gov ID
- NCT04245865
- Acronym / sponsor ID
- Toco-CoR / Toco-CoR
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- Colorectal cancer, Tocotrienol, Natural killer cells, Circulating tumor DNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jan 2020 (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.
This double blind, randomized phase II trial will investigate whether the addition of tocotrienol will improve the effect and lower the toxicity of standard chemotherapy and bevacizumab. Half of the patients will receive tocotrienol and the other half placebo. Treatment is planned for a period of maximum six months and will be discontinued earlier in case of progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A, standard treatment + tocotrienol | Experimental | Drug: Fluorouracil, Drug: Calcium folinate, Drug: Oxaliplatin, Drug: Bevacizumab, Drug: Capecitabine, Dietary Supplement: TocotrienolFluorouracil + calcium folinate + oxaliplatin + bevacizumab + tocotrienol OR capecitabine + bevacizumab + tocotrienol |
| Arm B, standard treatment + placebo | Placebo comparator | Drug: Fluorouracil, Drug: Calcium folinate, Drug: Oxaliplatin, Drug: Bevacizumab, Drug: Capecitabine, Other: PlaceboFluorouracil + calcium folinate + oxaliplatin + bevacizumab + placebo OR capecitabine + bevacizumab + placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histopathologically verified adenocarcinoma of the colon or rectum
- Metastatic disease
- Planned treatment with FOLFOX or capecitabine combined with bevacizumab
- Evaluable disease according to RECIST 1.1
- Performance status 0-2
Key exclusion criteria (9 listed)
- Other active malignant disease within 5 years prior to inclusion in the study.
- Other experimental therapy within 28 days prior to treatment initiation.
- Underlying medical disease not adequately treated.
- Surgery, including open biopsy, within 4 weeks prior to first dose of bevacizumab.
- Cerebral vascular attack, transient ischemic attack or subarachnoid hemorrhage within six months before start of treatment
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 |
|---|---|---|
| Fluorouracil2800 mg/m2 iv | Drug | Arm A, standard treatment + tocotrienol, Arm B, standard treatment + placebo |
| Calcium folinate400 mg/m2 iv | Drug | Arm A, standard treatment + tocotrienol, Arm B, standard treatment + placebo |
| Oxaliplatin85 mg/m2 iv | Drug | Arm A, standard treatment + tocotrienol, Arm B, standard treatment + placebo |
| Bevacizumab5 mg/kg OR 7.5 mg/kg iv | Drug | Arm A, standard treatment + tocotrienol, Arm B, standard treatment + placebo |
| Capecitabine2000 mg/m2 orally daily for two weeks | Drug | Arm A, standard treatment + tocotrienol, Arm B, standard treatment + placebo |
| Tocotrienol300 mg orally x 3 daily | Dietary supplement | Arm A, standard treatment + tocotrienol |
| PlaceboPlacebo orally x 3 daily | Other | Arm B, standard treatment + placebo |
Primary outcome
The rate of progression free patients at six months
Time frame: Six months after enrollment of the last patient
3 secondary outcomes
Time to first serious adverse event according to CTCAE 5.0
Time frame: Six months after enrollment of the last patient
Response rate as measured by RECIST 1.1
Time frame: Six months after enrollment of the last patient
Overall survival
Time frame: 12 months after enrollment of the last patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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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.
Torben F Hansen, MD, PhD study chair
Department of Oncology, Vejle Hospital - University Hospital of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluorouracil, Calcium folinate and Oxaliplatin in people with Colorectal Cancer Metastatic, run by Vejle Hospital at 1 site in Denmark.
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 18 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
The rate of progression free patients at six months (time frame: Six months after enrollment of the last patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.