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Phase II randomized trial to assess the effect of intensive vs standard adjuvant chemotherapy in localised colon cancer with circulating tumor DNA

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518131-11-02
Acronym
CIRCULATE-SPAIN-01
Enrollment
124
Registered
2025-01-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Localised Colon Cancer (stage II-III)

Brief summary

Phase IIa: Proportion of patients who negativize ctDNA after treatment., Phase IIb: Proportion of patients who negativize ctDNA after treatment in intensive group versus standard of care.

Detailed description

Phase IIb:Disease-free survival comparison between both treatment groups 24 months after treatment., Phase IIb: Disease-free survival comparison between both treatment groups 12 months after treatment., Phase IIb: Proportion of patients treated with triplet combination chemotherapy of FOLFOXIRI presenting adverse events in comparison to conventional adjuvant treatment (CAPOX)., Phase IIb: QLQ-C30 Quality of Life of Cancer Patients and QLQ – CR29, comparison scores between groups at baseline, 3 months and end of treatment.

Interventions

DRUGCapecitabina KERN PHARMA 150 mg comprimidos recubiertos con película EFG
DRUGOxaliplatin Hospira 5 mg/ml concentrate for solution for infusion
DRUGFluorouracilo Accord 50 mg/ml solución inyectable o para perfusión EFG
DRUGIrinotecán Hospira 20 mg/mL concentrado para solución para perfusión EFG.
DRUGCapecitabina Kern Pharma 300 mg comprimidos recubiertos con película EFG
DRUGFOLINATO CÁLCICO NORMON 350 mg Polvo para solución inyectable EFG.
DRUGCapecitabina KERN PHARMA 500 mg comprimidos recubiertos con película EFG
DRUGFOLINATO CÁLCICO NORMON 50 mg Polvo y disolvente para solución inyectable EFG.

Sponsors

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Phase IIa: Proportion of patients who negativize ctDNA after treatment., Phase IIb: Proportion of patients who negativize ctDNA after treatment in intensive group versus standard of care.—

Secondary

MeasureTime frame
Phase IIb:Disease-free survival comparison between both treatment groups 24 months after treatment., Phase IIb: Disease-free survival comparison between both treatment groups 12 months after treatment., Phase IIb: Proportion of patients treated with triplet combination chemotherapy of FOLFOXIRI presenting adverse events in comparison to conventional adjuvant treatment (CAPOX)., Phase IIb: QLQ-C30 Quality of Life of Cancer Patients and QLQ – CR29, comparison scores between groups at baseline, 3 months and end of treatment.—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026