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Clinical Trials/2024-518131-11-02
2024-518131-11-02
Not yet recruiting
Phase 2

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

Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA7 sites in 1 country124 target enrollmentStarted: January 24, 2025Last updated:
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Overview

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Enrollment
124
Locations
7
Primary Endpoint
Phase IIa: Proportion of patients who negativize ctDNA after treatment.
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

Phase IIa: To analyse the potential effect of FOLFOXIRI as an intensive adjuvant treatment for ctDNA clearance as a surrogate biomarker of treatment efficacy. Phase IIb: To study differences on the conversion rate between an intensive adjuvant treatment (FOLFOXIRI) versus conventional adjuvant therapy (CAPOX).

Eligibility Criteria

Ages
18 years to 65+ years (65+ Years, 18-64 Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •CIRCULATE-SPAIN-01 trial written informed consent.
  • •Age ≥ 18 years and ≤ 75 years.
  • •Histologically confirmed diagnosis of operable stage II or stage III Colon Cancer.
  • •Postoperative, ctDNA positive.
  • •ECOG performance status 0-
  • •Normal organ functions, as follows: Absolute neutrophil count (ANC) ≥1500/μL Platelets ≥100.000/μL Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 x ULN AST (SGOT) and ALT (SGPT) ≤2.5 x ULN

Exclusion Criteria

  • •Patients having an MSI-H/MMRd tumor are excluded from the study (done according to standard clinical practice).
  • •Acute or subacute intestinal occlusion or history of inflammatory bowel disease.
  • •Pre-existing neuropathy > grade
  • •Known grade 3 or 4 allergic reaction to any of the components of the treatment.
  • •Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency.
  • •Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant.
  • •Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required.
  • •Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection. Note: no testing for Hepatitis B and Hepatitis C is required.
  • •Has a known history of active TB (Bacillus Tuberculosis).
  • •History of another neoplastic disease, unless in remission for ≥ 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.

Outcomes

Primary Outcomes

Phase IIa: Proportion of patients who negativize ctDNA after treatment.

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.

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

Secondary Outcomes

  • 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.

Investigators

Sponsor
Instituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA
Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

UICEC

Scientific

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

Study Sites (7)

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