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Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients | Clinical Trials | Clareo Health

SUSPENDEDPHASE2

Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients

Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment of Stage III and High-risk Stage II Resected Colon Cancer Patients With Adjuvant FOLFOXIRI and/or Post-adjuvant Trifluridine/Tipiracil

NCT05062889•Gruppo Oncologico del Nord-Ovest

View on ClinicalTrials.gov

Summary

The aims of this study are to evaluate if an intensified adjuvant treatment with FOLFOXIRI could increase the rate of cases with undetectable ct-DNA after chemotherapy and to evaluate if a further adjuvant treatment with Trifluridine/Tipiracil could increase the rate of cases with undetectable ct-DNA and therefore improve DFS in a population at high-risk of relapse. An additional target-driven cohort of HER2+ RAS wild-type colon cancer patients will be assessed for ct-DNA clearance after a tailored treatment with Trastuzumab and Tucatinib plus FOLFOX

Detailed Description

This is a prospective, open-label, multicentre study, including two phase II randomized trials. In Part 1 resected stage III and high-risk stage II colon cancer patients with positive ct- DNA after surgery will be randomized to receive FOLFOX for 12 cycles or CAPOX for 8 cycles (at investigator choice) versus FOLFOXIRI for 12 cycles. In Part 1 target-driven resected stage III and high-risk stage II HER2+ and RAS wild-type colon cancer patients with positive ct-DNA after surgery will receive Trastuzumab and Tucatinib plus FOLFOX for 12 cycles. In Part 2 resected stage III and high-risk stage II colon cancer patients with positive ct- DNA after the end of a fluoropyrimidine and oxaliplatin-based adjuvant therapy - either in the frame or outside of Part 1 - will be randomized to receive observation or Trifluridine/Tipiracil for 6 cycles.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent to study procedures;
•18 - 70 years of age ECOG Performance Status ≤ 1 or 71-75 years of age with ECOG Performance Status 0;
•Histologically confirmed stage III or high-risk stage II adenocarcinoma of colon including intraperitoneal rectal cancer. Stage II colon cancers are defined at high risk if at least one major prognostic factor (pT4, less than 12 nodes examined, clinical presentation with bowel perforation) or at least two minor prognostic factors (grade 3 or 4, clinical presentation with bowel obstruction, histological signs of vascular or lymphatic or perineural invasion, high preoperative CEA levels) are reported;
•Curative surgery performed no less than 4 and no more than 12 weeks prior to randomization (pending results of ct-DNA analysis, up to 2 cycles of FOLFOX/CAPOX are allowed to start the adjuvant treatment within 8-10 weeks after surgery);
•Contrast-enhanced chest and abdominal CT scan (or abdomen MRI and chest CT if contrast-enhanced CT scan is contraindicated) performed after the surgery and prior to randomization with no evidence of metastatic disease;
•Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue from the surgical specimen and blood sample for ct-DNA analysis within 28 days prior randomization;
•Positive ct-DNA after surgery (central assessment);
•Neutrophils ≥1.5 x 109/L, Platelets ≥100 x 109/L, Hgb ≥ 9 g/dl;
•Total bilirubin ≤1.5 fold the upper-normal limits (UNL), ASAT (SGOT) and/or ALAT (SGPT) ≤2.5 x UNL (or \<5 x UNL in the case of liver metastases), alkaline phosphatase ≤2.5 x UNL (or \<5 x UNL in case of liver metastases);
•Creatinine clearance ≥50 mL/min or serum creatinine ≤1.5 x UNL;
+35 more criteria

Exclusion Criteria

•Part 1, adjuvant phase and Part 2, post-adjuvant phase
•Any evidence of metastatic disease (radiological or pathological metastasis);
•Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections) after surgery;
•Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ;
•For Part 1 only: patient with complete dihydropyrimidine dehydrogenase (DPYD) deficiency (homozygous of the following DPYD polymorphisms: c1679GG, c1905+1AA, c2846TT);
•History or evidence upon physical examination of CNS disease unless adequately treated;
•Clinical signs of malnutrition;
•Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration;
•Evidence of bleeding diathesis or coagulopathy;
•Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication;
+10 more criteria

Locations (28)

Fondazione Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Azienda Ospedaliera Cardinale Giovanni Panico

Tricase, Lecce, Italy

Ospedale San Donato di Arezzo

Arezzo, Italy

Spedali Civili di Brescia

Brescia, Italy

Fondazione POLIAMBULANZA ISTITUTO OSPEDALIERO

Brescia, Italy

AOU Cagliari PO Policlinico Universitario Duilio Casula Presidio Policlinico Universitario "Duilio Casula"

Cagliari, Italy

A.O.U. di Ferrara Arcispedale Sant'Anna

Ferrara, Italy

A.O.U Careggi

Florence, Italy

E.O. Ospedali Galliera di Genova

Genova, Italy

Ospedale Misericordia di Grosseto

Grosseto, Italy

Key Dates

Start Date

May 17, 2023

Primary Completion Date

October 1, 2027

Completion Date

December 1, 2029

Last Updated

February 3, 2026

Enrollment

477

ESTIMATED participants

Conditions

Stage II Colon CancerStage III Colon CancerHER2-positive Colon CancerRAS Wild-type Colon Cancer

Interventions

5-Fluorouracil continuous infusion FOLFOXIRI schedule

DRUG

5-Fluorouracil bolus FOLFOX schedule

DRUG

5-Fluorouracil continuous infusion FOLFOX schedule

DRUG

Oxaliplatin FOLFOX and FOLFOXIRI schedule

DRUG

Oxaliplatin CAPOX schedule

DRUG

L-Leucovorin

DRUG

Capecitabine

DRUG

Irinotecan

DRUG

Trifluridine/Tipiracil

DRUG

Trastuzumab

DRUG

Tucatinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer

TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study

Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer

Exercise and Colon Cancer

Adjuvant Chemotherapy in High Risk Stage II Colon Cancer