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NCT02959541
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
NA trial testing Leucovorin in Colon Cancer in 48 participants. Status unknown.
26 May 2020
Quick facts
| Lead sponsor | Vastra Gotaland Region |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 48 |
| Start date | 1 September 2016 |
| Primary completion | 26 May 2020 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Leucovorin (leucovorin) — full drug profile →
Conditions studied
- Colon Cancer — all drugs for Colon Cancer →
- Chemotherapy — all drugs for Chemotherapy →
Sponsor
Vastra Gotaland Region — full company profile →
Who can join
18 and older, any sex, with Colon Cancer or Chemotherapy. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
[6R] 5,10-methylene-THF - tumor
Time frame: First day during surgery
Tissue concentration of \[6R\] 5,10-methylene-THF in the tumor -
[6R] 5,10-methylene-THF - adjacent mucosa
Time frame: First day during surgery
Tissue concentration of \[6R\] 5,10-methylene-THF in adjacent mucosa -
5-formyl-THF - tumor
Time frame: First day during surgery
Tissue concentration of 5-formyl-THF in the tumor -
5-formyl-THFin - adjacent mucosa
Time frame: First day during surgery
Tissue concentration of 5-formyl-THFin the adjacent mucosa -
5-methyl-THF - tumor
Time frame: First day during surgery
Tissue concentration of 5-methyl-THF in the tumor -
5-methyl-THF - adjacent mucosa
Time frame: First day during surgery
Tissue concentration of 5-methyl-THF in the adjacent mucosa
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02959541
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Vastra Gotaland Region trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02959541 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vastra Gotaland Region
- Last refreshed: 8 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02959541.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing