Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05062889
Study type Interventional
Source Gruppo Oncologico del Nord-Ovest
Contact Roberto Moretto, MD
Phone +39050992069
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date December 2021
Completion date March 2027

See also
  Status Clinical Trial Phase
Completed NCT00025337 - Combination Chemotherapy With or Without Bevacizumab Compared With Bevacizumab Alone in Treating Patients With Advanced or Metastatic Colorectal Cancer That Has Been Previously Treated Phase 3
Recruiting NCT04164069 - Dasatinib in Preventing Oxaliplatin-Induced Peripheral Neuropathy in Patients With Colorectal Cancer Receiving FOLFOX and Bevacizumab Phase 1
Recruiting NCT02280278 - Cytokine-induced Killer Cell Immunotherapy for Surgical Resected Stage III Colorectal Cancer Patients After Chemotherapy Phase 3
Completed NCT01191684 - Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer Phase 1
Completed NCT00551421 - Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer Phase 1/Phase 2
Recruiting NCT03958435 - Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery
Completed NCT01890213 - Immunotherapy With CEA(6D) VRP Vaccine (AVX701) in Patients With Stage III Colorectal Cancer Phase 1
Completed NCT00028496 - Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer Phase 1
Recruiting NCT03255434 - LEAn Body Mass Normalization of OXaliplatin Based Chemotherapy Phase 2
Completed NCT01126346 - Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) N/A
Terminated NCT00087191 - EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer N/A
Completed NCT00003835 - Combination Chemotherapy in Treating Patients With Stage III Colon Cancer Phase 3
Enrolling by invitation NCT04416490 - Oxaliplatin Adjuvant Chemotherapy After Curative Resection of Primary Colon Cancer
Active, not recruiting NCT02836977 - Maintenance Tegafur-uracil Versus Observation Following Adjuvant Oxaliplatin-based Regimen in Patients With Stage III Colon Cancer After Radical Resection N/A
Completed NCT00005818 - SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer Phase 1/Phase 2
Completed NCT00019006 - Vaccine Therapy in Treating Patients With Colon, Pancreatic, or Lung Cancer Phase 1
Terminated NCT01606124 - Polyphenon E in Treating Patients With High-Risk of Colorectal Cancer Phase 2
Completed NCT01158274 - RO4929097 and Capecitabine in Treating Patients With Refractory Solid Tumors Phase 1
Completed NCT00134069 - Sorafenib, Cetuximab, and Irinotecan in Treating Patients With Advanced or Metastatic Colorectal Cancer Phase 1
Completed NCT00138177 - Suberoylanilide Hydroxamic Acid, Fluorouracil, Leucovorin, and Oxaliplatin in Treating Patients With Progressive Metastatic or Unresectable Colorectal Cancer or Other Solid Tumors Phase 1