Status:
UNKNOWN
Modelle 001, TS-inhibition in Colorectal Liver Metastases Comparing Arfolitixorin and Calciumfolinate
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Isofol Medical AB
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
Brief Summary
A study that is blinded to the patient and the investigator where the combination of Arfolitixorin + 5-FU is compared to Calciumfolinate + 5-FU. The patients will be randomised and will receive the ab...
Detailed Description
Arfolitixorin (\[6R\] 5,10-methylenetetrahydrofolate) is a folate based biomodulator designed to replace leucovorin. Arfolitixorin is the key active metabolite of leucovorin (LV) and does in contrast ...
Eligibility Criteria
Inclusion
- 3.1 Inclusion criteria
- Patients must sign an informed consent document.
- At least two liver metastases secondary to CRC. Patients must have removable metastases amenable to surgery.
- Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG). Performance Status scale. (See Protocol Attachment 1.)
- For women: Must be surgically sterile, postmenopausal, or compliant with a contraceptive regimen during and for 3 months after treatment. Fertile women must have a negative serum or urine pregnancy test (within 7 days before enrolment) and must not be lactating.
- For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 3 months after treatment.
- Patient legally competent and able to communicate effectively with the study personnel as judged by the investigator.
- Patient likely to co-operate during the study.
- Patients must be at least 18 years of age.
Exclusion
- Concurrent administration of any other anti-tumour therapy minimum 3 weeks before surgery according to clinical practise.
- 2\. Treatment within the last 30 days with a drug/device that has not received regulatory approval for any indication at the time of study entry.
- 3\. Any intake of medication, which could influence folate, and vitamin B12 status, within 30 days of surgery.
- 4\. Serious concomitant systemic disorders (e.g., active infection including HIV, cardiac disease) that in the opinion of the investigator would compromise the patient's ability to complete the study.
- 5\. Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- 6\. Patients with a high risk of postoperative liver failure due to advanced liver metastatic load.
- 7\. Pregnancy. 8. History of significant neurological or mental disorder, including seizures or dementia.
- 9\. Presence of clinically relevant (i.e., detectable by physical examination) third-space fluid collection (e.g., ascites, pleural effusion) that cannot be controlled by drainage or other procedures prior to study entry.
- 10\. Known hypersensitivity to 5-FU and or Calciumfolinate/Arfolitixorin.
Key Trial Info
Start Date :
February 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04126655
Start Date
February 5 2020
End Date
November 1 2021
Last Update
August 27 2020
Active Locations (1)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden, 41345