EUCTR2021-000507-20-ES
Active, not recruiting
Phase 1
Phase II randomized trial to assess the effect of intensive vs standard adjuvant chemotherapy in localised colon cancer with circulating tumor DNA
Instituto de Investigación Sanitaria INCLIVA0 sites164 target enrollmentOctober 19, 2021
Conditionsocalised 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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ocalised Colon Cancer (stage II-III)
- Sponsor
- Instituto de Investigación Sanitaria INCLIVA
- Enrollment
- 164
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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.
Outcomes
Primary Outcomes
Not specified
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