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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan 165 mg/m2 iv | Drug | Max. 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first serious adverse event | 6 months after the last patient has finished chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of non-planned hospitalizations calculated from date of first treatment until 1 month after completed chemotherapy | 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 |
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Inclusion Criteria:
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
Life expectancy > 3 months
Organ and bone marrow function as follows:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars H Jensen, PhD | Department of Oncology, Vejle Hospital | Study Chair |
| Louise R Larsen, MD | Department of Oncology, Vejle Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Vejle Hospital | Vejle | DK-7100 | Denmark |
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| Oxaliplatin 85 mg/m2 iv | Drug | Max. 4 months |
|
| Calcium folinate 200 mg/m2 iv | Drug | Max. 6 months |
|
| 5-fluorouracil 3200 mg/m2 | Drug | Max. 6 months |
|
| Tocotrienol | Dietary Supplement | Max. 2 years or at the discretion of the investigator |
|
| Placebo | Drug | Max. 2 years or at the discretion of the investigator |
|
| 6 months after the last patient has finished chemotherapy |
| Death during treatment calculated from date of first treatment until 1 month after completed chemotherapy | 6 months after the last patient has finished chemotherapy |
| Response rate | 6 months after the last patient has finished chemotherapy |
| Progression free survival | 6 months after the last patient has finished chemotherapy |
| Overall survival | 6 months after the last patient has finished chemotherapy |
| Number of patients with treatment related adverse events as assessed by CTCAE v.4.0 | 6 months after the last patient has finished chemotherapy |
| Quality of life as measured by combined questionnaire consisting of EORTC QLQ-C30 and CR29 | 6 months after the last patient has finished chemotherapy |
| Resection rate | 6 months after the last patient has finished chemotherapy |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D024508 | Tocotrienols |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014810 | Vitamin E |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
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