Colorectal CancerPhase 2NCT02705300
Side Effects to FOLFOXIRI + Tocotrienol/Placebo as First Line Treatment of Metastatic Colorectal Cancer
A Phase 2 study testing Irinotecan 165 mg/m2 iv, Oxaliplatin 85 mg/m2 iv and Calcium folinate 200 mg/m2 iv in people with Colorectal Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial summary
Treatment with FOLFOXIRI (5-fluorouracil, oxaliplatin, irinotecan) can be effective, but it has serious side effects, which may require hospitalization. The purpose of this study is to investigate whether the addition of tocotrienol can reduce the side effects to FOLFOXIRI otherwise leading to hospitalization. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Irinotecan 165 mg/m2 iv, Oxaliplatin 85 mg/m2 iv and Calcium folinate 200 mg/m2 iv
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 6 May 2016to 27 Mar 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically verified colorectal adenocarcinoma.
- Patients to receive first line treatment of metastatic disease, including potentially resectable or non-resectable disease
- > 6 months without recurrence after end of adjuvant chemotherapy for radically treated stage II or III colorectal cancer
- Disease evaluable according to RECIST 1.1, but not necessarily measurable disease.
- Age 18-75 years
- Performance status (PS) 0-1. If age 71-75, then PS 0
Show all 14Show fewer
- Life expectancy > 3 months
- Organ and bone marrow function as follows:
- Neutrophil count ≥ 1.5 x 10^9/L
- Thrombocytes ≥ 100 x 10^9/L
- Total bilirubin ≤ 1.5 x upper level of normal (ULN)
- Alanine transaminase (ALAT) ≤ 2.5 x ULN (or≤ 5 x ULN in case of liver metastases)
- Fertile women must present negative pregnancy test. Male (with a female fertile partner) as well as female patients must use secure contraceptives during and 6 months after end of treatment.
- Orally and written informed consent to treatment and biobank
Who cannot join
- Primarily resectable metastases
- Chemotherapy, radiotherapy or immunotherapy within 4 weeks
- Known neuropathy ≥ grade 2
- Serious competitive medical condition
- Other concurrent malignant disease other than non-melanoma skin cancer
- Previous serious and unexpected reactions to 5-fluorouracil, calcium folinate, oxaliplatin, irinotecan or capecitabine.
- Hypersensitivity to one or more of the active substances or auxilliary agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Investigation of Side Effects to FOLFOXIRI in Combination With Tocotrienol or Placebo as First Line Treatment of Metastatic Colorectal Cancer
Treatment with FOLFOXIRI (5-fluorouracil, oxaliplatin, irinotecan) can be effective, but it has serious side effects, which may require hospitalization.
The purpose of this study is to investigate whether the addition of tocotrienol can reduce the side effects to FOLFOXIRI otherwise leading to hospitalization.
- Conditions
- Colorectal Cancer
- Being tested
- Irinotecan 165 mg/m2 iv, Oxaliplatin 85 mg/m2 iv, Calcium folinate 200 mg/m2 iv, 5-fluorouracil 3200 mg/m2, Tocotrienol
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan 165 mg/m2 ivDrug
Max. 4 months
Oxaliplatin 85 mg/m2 ivDrug
Max. 4 months
Calcium folinate 200 mg/m2 ivDrug
Max. 6 months
5-fluorouracil 3200 mg/m2Drug
Max. 6 months
TocotrienolDietary supplement
Max. 2 years or at the discretion of the investigator
PlaceboDrug
Max. 2 years or at the discretion of the investigator
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy plus tocotrienol | Experimental | Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.
Daily: Tocotrienol 300 mg x 3 daily Receives: Drug: Irinotecan 165 mg/m2 iv; Drug: Oxaliplatin 85 mg/m2 iv; Drug: Calcium folinate 200 mg/m2 iv; Drug: 5-fluorouracil 3200 mg/m2; Dietary Supplement: Tocotrienol |
| Chemotherapy plus placebo | Placebo comparator | Every 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion.
Daily: Placebo x 3 daily Receives: Drug: Irinotecan 165 mg/m2 iv; Drug: Oxaliplatin 85 mg/m2 iv; Drug: Calcium folinate 200 mg/m2 iv; Drug: 5-fluorouracil 3200 mg/m2; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first serious adverse event
Measured: 6 months after the last patient has finished chemotherapy
Secondary outcomes (9)
Number of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy
Measured: 6 months after the last patient has finished chemotherapy
Duration of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy
Measured: 6 months after the last patient has finished chemotherapy
Death during treatment calculated from date of first treatment until 1 month after completed chemotherapy
Measured: 6 months after the last patient has finished chemotherapy
Response rate
Measured: 6 months after the last patient has finished chemotherapy
Progression free survival
Measured: 6 months after the last patient has finished chemotherapy
Overall survival
Measured: 6 months after the last patient has finished chemotherapy
Number of patients with treatment related adverse events as assessed by CTCAE v.4.0
Measured: 6 months after the last patient has finished chemotherapy
Quality of life as measured by combined questionnaire consisting of EORTC QLQ-C30 and CR29
Measured: 6 months after the last patient has finished chemotherapy
Resection rate
Measured: 6 months after the last patient has finished chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study start6 May 2016
- Primary completionAug 2019
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars H Jensen, PhD, Study chair, Department of Oncology, Vejle HospitalLouise R Larsen, MD, Principal investigator, Department of Oncology, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705300
- Sponsor's protocol ID
- FOLFOXIRI-Toco
- Status last verified
- Aug 2024
- First submitted
- 26 Feb 2016
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Investigation of Side Effects to FOLFOXIRI in Combination With Tocotrienol or Placebo as First Line Treatment of Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02705300
- Acronym / sponsor ID
- FOLFOXIRI-Toco
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 6 May 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 10 Mar 2016 (estimated)
- 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.
Treatment with FOLFOXIRI (5-fluorouracil, oxaliplatin, irinotecan) can be effective, but it has serious side effects, which may require hospitalization.
The purpose of this study is to investigate whether the addition of tocotrienol can reduce the side effects to FOLFOXIRI otherwise leading to hospitalization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy plus tocotrienol | Experimental | Drug: Irinotecan 165 mg/m2 iv, Drug: Oxaliplatin 85 mg/m2 iv, Drug: Calcium folinate 200 mg/m2 iv, Drug: 5-fluorouracil 3200 mg/m2, Dietary Supplement: TocotrienolEvery 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion. Daily: Tocotrienol 300 mg x 3 daily |
| Chemotherapy plus placebo | Placebo comparator | Drug: Irinotecan 165 mg/m2 iv, Drug: Oxaliplatin 85 mg/m2 iv, Drug: Calcium folinate 200 mg/m2 iv, Drug: 5-fluorouracil 3200 mg/m2, Drug: PlaceboEvery 2 weeks: irinotecan 165 mg/m2 iv, oxaliplatin 85 mg/m2 iv, calcium folinate 200 mg/m2 iv, and 5-fluorouracil 3200 mg/m2 as a 46 hour infusion. Daily: Placebo x 3 daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically verified colorectal adenocarcinoma.
- Patients to receive first line treatment of metastatic disease, including potentially resectable or non-resectable disease
- > 6 months without recurrence after end of adjuvant chemotherapy for radically treated stage II or III colorectal cancer
- Disease evaluable according to RECIST 1.1, but not necessarily measurable disease.
- Age 18-75 years
Key exclusion criteria (7 listed)
- Primarily resectable metastases
- Chemotherapy, radiotherapy or immunotherapy within 4 weeks
- Known neuropathy ≥ grade 2
- Serious competitive medical condition
- Other concurrent malignant disease other than non-melanoma skin cancer
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 |
|---|---|---|
| Irinotecan 165 mg/m2 ivMax. 4 months | Drug | Chemotherapy plus placebo, Chemotherapy plus tocotrienol |
| Oxaliplatin 85 mg/m2 ivMax. 4 months | Drug | Chemotherapy plus placebo, Chemotherapy plus tocotrienol |
| Calcium folinate 200 mg/m2 ivMax. 6 months | Drug | Chemotherapy plus placebo, Chemotherapy plus tocotrienol |
| 5-fluorouracil 3200 mg/m2Max. 6 months | Drug | Chemotherapy plus placebo, Chemotherapy plus tocotrienol |
| TocotrienolMax. 2 years or at the discretion of the investigator | Dietary supplement | Chemotherapy plus tocotrienol |
| PlaceboMax. 2 years or at the discretion of the investigator | Drug | Chemotherapy plus placebo |
Primary outcome
Time to first serious adverse event
Time frame: 6 months after the last patient has finished chemotherapy
9 secondary outcomes
Number of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy
Time frame: 6 months after the last patient has finished chemotherapy
Duration of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy
Time frame: 6 months after the last patient has finished chemotherapy
Death during treatment calculated from date of first treatment until 1 month after completed chemotherapy
Time frame: 6 months after the last patient has finished chemotherapy
Response rate
Time frame: 6 months after the last patient has finished chemotherapy
Progression free survival
Time frame: 6 months after the last patient has finished chemotherapy
Overall survival
Time frame: 6 months after the last patient has finished chemotherapy
Number of patients with treatment related adverse events as assessed by CTCAE v.4.0
Time frame: 6 months after the last patient has finished chemotherapy
Quality of life as measured by combined questionnaire consisting of EORTC QLQ-C30 and CR29
Time frame: 6 months after the last patient has finished chemotherapy
Resection rate
Time frame: 6 months after the last patient has finished chemotherapy
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 29 Aug 2024.
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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, PhD study chair
Department of Oncology, Vejle Hospital
Louise R Larsen, MD principal investigator
Department of Oncology, Vejle Hospital
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 Irinotecan 165 mg/m2 iv, Oxaliplatin 85 mg/m2 iv and Calcium folinate 200 mg/m2 iv in people with Colorectal Cancer, 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 14 inclusion and 7 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 29 Aug 2024. 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?
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?
Time to first serious adverse event (time frame: 6 months after the last patient has finished chemotherapy). 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 29 Aug 2024.