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Colon Cancer Stage II clinical trials

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NCT ID: NCT06434896 Recruiting - Recurrence Clinical Trials

Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial

CrEATE
Start date: March 5, 2020
Phase: N/A
Study type: Interventional

Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design). Patients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.

NCT ID: NCT06108310 Recruiting - Clinical trials for Colon Cancer Stage III

ArTificial inTelligence-based RAdiogenomics in Colon Tumors

ATTRACT
Start date: January 2, 2021
Phase:
Study type: Observational

The goal of this clinical trial is to develop an artificial intelligence-based model to assess radiogenomics signature of colon tumor in patients with stage II-III colon cancer. The main question it aims to answer is: • Can artificial intelligence-based algorithm of radiomics features combined with clinical factors, biochemical biomarkers, and genomic data recognise tumor behaviour, aggressiveness, and prognosis, identifying a radiogenomics signature of the tumor? Participants will - undergo a preoperative contrast-enhanced CT examination; - undergo surgical excision of colon cancer - undergo adjuvant therapy if deemed necessary based on current guidelines

NCT ID: NCT05194878 Recruiting - Clinical trials for Colon Cancer Stage III

Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers

Start date: December 1, 2021
Phase: Phase 3
Study type: Interventional

BACKGROUND: In patients with high risk stage II and stage III colon cancer (CC), curative surgery followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become a standard treatment. However, 20 to 30 % of these patients will develop distant metastasis, which ultimately result in death. Perioperative chemotherapy is a promising strategy with potential benefits that could be more effective at eradicating micrometastases. Moreover, shrinking tumor before surgery not only facilitate removal of all the tumor by the surgeon but also reduce tumor cell spreading during the procedure. With recent advances in radiology, preoperative computed tomography allows a good prediction of tumor stage (wall penetration and nodal involvement) prior to surgery. The investigators conducted the present randomized study to explore whether perioperative chemotherapy with FOLFOXIRI regimen compared with postoperative chemotherapy could improve disease-free survival in patients with radiologically staged, High-risk, but resectable Stage II or III colon cancer. OBJECTIVE: The primary objective of this study is to evaluate the efficacy of perioperative chemotherapy with FOLFOXIRI regimen compared to postoperative chemotherapy in patients with High-risk Resectable Stage II and III colon cancer. Secondary objectives are efficacy in terms of R0 resection rate, overall survival (OS), relapse-free survival (RFS), down-staging of primary tumors, and tolerability of perioperative therapy and postoperative complications.

NCT ID: NCT04089631 Recruiting - Clinical trials for Colon Cancer Stage II

Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation

CIRCULATE
Start date: June 26, 2020
Phase: Phase 3
Study type: Interventional

The CIRCULATE study evaluates the adjuvant therapy in patients with colon cancer UICC stage II. The primary aim of the study is to compare the disease free survival in patients who are positive for postoperative circulating tumour DNA with vs. without capecitabine.