Short summary

The study is a phase III trial of neoadjuvant chemotherapy in locally advanced colon cancer. After surgery the patients fulfilling the international criteria for adjuvant chemotherapy receive adjuvant chemotherapy, while the remaining are offered observation only.

Rationale

The study is based on a phase II trial, which showed high response rates to neoadjuvant chemotherapy. Half of the high-risk patients receiving neoadjuvant chemotherapy were converted to a low-risk status, i.e. they did not fulfil the criteria for adjuvant chemotherapy. This group had long-term disease free survival.

The same principles are now investigated in an international multicenter phase III trial. 

Description of the cohort

Patients with histologically verified adenocarcinoma of the colon and a T3 tumor with extratumoral invasion above or equal to 5 mm or a T4 tumor, as assessed by CT scan, are included at participating centers in Denmark, Norway, and Sweden. 

Data and biological material

The study collects various clinical data with disease free survival as the primary endpoint. Translational research is also part of the study with collection of blood samples and biopsy specimens. 

Collaborating researchers and departments

Klinisk Institutt 2, Haukeland University Hospital, Bergen, Norway

• Professor, Sponsor and Study Chair Anders Jakobsen, MD, DMSc
• Professor and Coordinating Investigator Norway Olav Dahl, MD

Department of Gastrointestinal Oncology, Sahlgrenska University Hospital, Göteborg, Sweden

• Coordination Investigator Sweden, Göran Carlsson, MD, PhD

Department of Oncology, Vejle Hospital

Associate Professor and Coordinating Investigator Denmark Lars Henrik Jensen, MD, PhD

• Investigator John Pløen, MD

Department of Oncology, Herlev Hospital

• Investigator Ole Larsen, MD

Department of Oncology, Roskilde Hospital

• Investigator Jim Stenfatt Larsen, MD

Department of Oncology, Copenhagen University Hospital (Rigshospitalet)

• Investigator Lars Reiter, MD

Department of Oncology, Hillerød Hospital

• Investigator Fahimeh Andersen, MD

Department of Oncology, Næstved Hospital

• Investigator Wojciek Pawlak, MD