Clinical trial · Interventional
PK/PD Investigation of Calciumfolinat in Blood, Tumor and Adjacent Mucosa in Patient With Colon Cancer
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
NCT02959541CI-TRIAL-00059031unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leucovorin | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Calciumfolinat 60 mg/m²
- description
- Intravenous infusion of Calciumfolinat 60 mg/m²given to patients with colon cancer at the time for the operation of the colon cancer.
- interventionNames
- Drug: Leucovorin
- type
- OTHER
- label
- Calciumfolinat 200 mg/m²
- description
- Intravenous infusion of Calciumfolinat 200 mg/m² given to patients with colon cancer at the time for the operation of the colon cancer.
- interventionNames
- Drug: Leucovorin
- type
- OTHER
- label
- Calciumfolinat 500 mg/ m²
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have an operable colon cancer that is determined to colorectal surgery 2. Patients must sign an informed consent document 3. Patients must be ≥ 18 years of age 4. Fertile women must present a negative pregnancy test and use secure contraceptives during and three months after treatment Exclusion Criteria: 1. Neo-adjuvant chemotherapy within the last 30 days 2. 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 3. Female patients: currently pregnant or breast-feeding 4. Patient with epileptic medication, such as fenobarbital, primidon, fenytoin och succinimider
References
Publications (0)
Data not yet available
No reference posted for this study.