Localised Colon Cancer (stage II-III) MedDRA version: 21.0 Level: PT Classification code 10009954 Term: Colon cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10009955 Term: Colon cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Irinotecan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IRINOTECAN
CAS Number: 97682-44-5
Trade Name: OXALIPLATIN
Pharmaceutical Form: Concentrate for s
Sponsors
Instituto de Investigación Sanitaria INCLIVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. CIRCULATE-SPAIN-01 trial written informed consent. 2. Age = 18 years and = 75 years. 3. Histologically confirmed diagnosis of operable stage II or stage III Colon Cancer. 4. Postoperative, ctDNA positive 5. ECOG performance status 0-1. 6. Normal organ functions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 82 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 82
Exclusion criteria
Exclusion criteria: 1. Patients having an MSI-H/MMRd tumor are excluded from the study (done according to standard clinical practice). 2. 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. 3. Had an incomplete diagnostic colonoscopy and/or polyps’ removal for patients in whom the remaining colon was not removed or explored. Note: Patients with intraoperative complete colonoscopy or early perioperative complete colonoscopy. 4. Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage). 5. Current treatment with another investigational drug or participation in another investigational study. 6. Patient unable to comply with the study protocol owing to psychological, social or geographical reasons. 7. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study. 8. Inadequate contraception (male or female patients) if of childbearing or procreational potential. 9. Current clinically unconcluded cardiovascular disease. 10. Acute or subacute intestinal occlusion or history of inflammatory bowel disease. 11. Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment. 12. Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency. 13. Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant. 14. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required. 15. 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. 16. Has a known history of active TB (Bacillus Tuberculosis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: Phase IIb: a) To evaluate the impact of intensive chemotherapy treatment on disease-free survival in patients with positive ctDNA at 24 months after end of treatment b) To evaluate the disease-free survival at 12 months after end of treatment, according to the seroconversion rate (ctDNA positive that becomes ctDNA negative) in each treatment arm. c) To assess the toxicity of triplet combination chemotherapy of FOLFOXIRI compared with conventional adjuvant treatment (CAPOX) for patients with localized colon cancer. d) To evaluate the impact of FOLFOXIRI compared with CAPOX on quality of life in patients with localized colon cancer.;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: End of treatment and Follow up visits (month 10, month 14, month 18, month 22, month 26, month 30). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase IIb: - Disease-free survival comparison between both treatment groups 24 months after treatment. - Disease-free survival comparison between both treatment groups 12 months after treatment. - Proportion of patients treated with triplet combination chemotherapy of FOLFOXIRI presenting adverse events in comparison to conventional adjuvant treatment (CAPOX). - QLQ-C30 Quality of Life of Cancer Patients and QLQ – CR29, comparation scores between groups at baseline, 3 months and end of treatment.;Timepoint(s) of evaluation of this end point: Screening, Treatment Visits, End of tratment, Follow up visits (month 10, month 14, month 18, month 22, month 26, month 30). | — |
Countries
Spain
Contacts
Public ContactSubdirectora Científica
Instituto de Investigación Sanitaria INCLIVA
Outcome results
None listed