EUCTR2018-003691-12-DE
Active, not recruiting
Phase 1
Circulating tumour DNA based decision for adjuvant treatment in colon cancer stage II evaluation (CIRCULATE) AIO-KRK-0217 - CIRCULATE
ConditionsColon cancer stage IIMedDRA 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 10038049Term: Rectal cancer stage IISystem 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
- Colon cancer stage II
- Sponsor
- Technische Universität Dresden
- Enrollment
- 4812
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria for screening phase:
- •1\) Resected colon cancer stage II,
- •Resected rectal cancer stage II, if there was no indication for
- •radiotherapy (i.e. due to the localisation in the upper third of
- •the rectum ), so that the treatment follows the recommenda\-
- •tions for colon cancer.
- •Patients, in whom the tumour stage is not yet know, can be en\-
- •rolled into the screening.
- •2\) Signed informed consent for the screening phase
- •Inclusion criteria for the randomised phase:
Exclusion Criteria
- •Exclusion criteria for Screening:
- •1\) Patients with known microsatellite instability (MSI\-H) or mismatch repair deficiency (dMMR)
- •2\) Known clinical high risk situation if it is regarded as certain indication for an adjuvant chemotherapy
- •3\) Patients, who have an obvious contra\-indication for adjuvant chemotherapy (i.e. due to the performance status, comorbidity, active second cancer or age). It should be considered that patients with an age of more than 75 years frequently not fulfil criteria for adjuvant chemotherapy.
- •4\) R1\- or R2\-status (patients with \[still] unknown R\-status can be screened)
- •5\) Patients, in whom the randomisation or chemotherapy is unfeasible due to logistic reasons (travel distance, compliance)
- •6\) Age \< 18 years
- •7\) Pregnant or breast feeding patients
- •Exclusion criteria for randomised phase:
- •1\) Patients with microsatellite instability (MSI\-H) or mismatch repair deficiency (dMMR)
Outcomes
Primary Outcomes
Not specified
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