NCT02959541

Brief Summary

This is an open randomized single site Pharmacokinetic and Pharmacodynamic study,of Calciumfolinat 60 mg/m², 200 mg/m² or 500 mg/ m² in blood, tumor and adjacent mucosa from patients with colon cancer

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2020

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 13, 2022

Status Verified

September 1, 2021

Enrollment Period

3.7 years

First QC Date

October 20, 2016

Last Update Submit

June 8, 2022

Conditions

Colon CancerChemotherapy

Keywords

Leukovorin

Outcome Measures

Primary Outcomes (8)

  • [6R] 5,10-methylene-THF - tumor

    Tissue concentration of \[6R\] 5,10-methylene-THF in the tumor

    First day during surgery

  • [6R] 5,10-methylene-THF - adjacent mucosa

    Tissue concentration of \[6R\] 5,10-methylene-THF in adjacent mucosa

    First day during surgery

  • 5-formyl-THF - tumor

    Tissue concentration of 5-formyl-THF in the tumor

    First day during surgery

  • 5-formyl-THFin - adjacent mucosa

    Tissue concentration of 5-formyl-THFin the adjacent mucosa

    First day during surgery

  • 5-methyl-THF - tumor

    Tissue concentration of 5-methyl-THF in the tumor

    First day during surgery

  • 5-methyl-THF - adjacent mucosa

    Tissue concentration of 5-methyl-THF in the adjacent mucosa

    First day during surgery

  • THF - tumor

    Tissue concentration of THF in the tumor

    First day during surgery

  • THF - adjacent mucosa

    Tissue concentration of THF in the adjacent mucosa

    First day during surgery

Secondary Outcomes (7)

  • AUC [6R] 5,10-methylene-THF

    Up to 24 hours

  • AUC 5-formyl-THF

    Up to 24 hours

  • AUC 5-methyl-THF

    Up to 24 hours

  • AUC THF

    Up to 24 hours

  • Correlation AUC - blood and tissue

    Up to 24 hours

  • +2 more secondary outcomes

Study Arms (3)

Calciumfolinat 60 mg/m²

OTHER

Intravenous infusion of Calciumfolinat 60 mg/m²given to patients with colon cancer at the time for the operation of the colon cancer.

Drug: Leucovorin

Calciumfolinat 200 mg/m²

OTHER

Intravenous infusion of Calciumfolinat 200 mg/m² given to patients with colon cancer at the time for the operation of the colon cancer.

Drug: Leucovorin

Calciumfolinat 500 mg/ m²

OTHER

Intravenous infusion of Calciumfolinat 500 mg/ m² given to patients with colon cancer at the time for the operation of the colon cancer.

Drug: Leucovorin

Interventions

LeucovorinDRUG
Also known as: Calciumfolinat is the brandname of Leucovorin
Calciumfolinat 200 mg/m²Calciumfolinat 500 mg/ m²Calciumfolinat 60 mg/m²

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have an operable colon cancer that is determined to colorectal surgery
  • Patients must sign an informed consent document
  • Patients must be ≥ 18 years of age
  • Fertile women must present a negative pregnancy test and use secure contraceptives during and three months after treatment

You may not qualify if:

  • Neo-adjuvant chemotherapy within the last 30 days
  • 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
  • Female patients: currently pregnant or breast-feeding
  • Patient with epileptic medication, such as fenobarbital, primidon, fenytoin och succinimider

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of surgery, Östra, Sahlgrenska University Hospital

Gothenburg, 416 85, Sweden

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Leucovorin

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

FormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoenzymesEnzymes and Coenzymes

Study Officials

  • Elinor Bexe Lindskog, MD, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

November 9, 2016

Study Start

September 1, 2016

Primary Completion

May 26, 2020

Study Completion

December 31, 2022

Last Updated

June 13, 2022

Record last verified: 2021-09

Locations

SE(1)