Study to assess the effect of intensive vs standard adjuvant chemotherapy in localised colon cancer with circulating tumor DNA.

Phase 1

• Conditions: ocalised Colon Cancer (stage II-III); MedDRA version: 21.0Level: PTClassification code 10009954Term: Colon cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.0Level: PTClassification code 10009955Term: Colon cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000507-20-ES
• Lead Sponsor: Instituto de Investigación Sanitaria INCLIVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-19
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 164

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified