Tumour Registry Colorectal Cancer (TKK)

Prospective and Retrospective Observation of the Adjuvant and Palliative Treatment Strategies in the Therapy of Colorectal Cancer in Germany

To describe treatment reality of patients with colorectal cancer treated by office-based and clinic-based medical oncologists in Germany.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer

Detailed Description

The TKK is a prospective, longitudinal, nation wide cohort study with the purpose to record information on the antineoplastic treatment of colorectal cancer in Germany. The registry will follow patients for up to five years. It will identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics, biomarker testing and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

The impact of nutrition (CoNut) and physical activity (CoNut) on the course of the adjuvant disease will be examined, as well as long-term effects of adjuvant treatment (CoTox) and the final phase of the palliative process (CoLife). Based on the available data a prognostic score will be developed.

• Study Type: Observational
• Enrollment (Actual): 7000

Contacts and Locations

Study Locations

• Germany
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79108
      • iOMEDICO AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Colorectal cancer patients undergoing antineoplastic treatment.

Description

Inclusion Criteria:

• Colorectal cancer
• 18 years and older
• Antineoplastic treatment

Exclusion Criteria:

• No colorectal cancer
• Below 18 years
• No antineoplastic treatment

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Course of Antineoplastic Treatment	5 years

Collaborators and Investigators

• Sponsor: iOMEDICO AG
• Collaborators: Arbeitsgemeinschaft fur Internistische Onkologie; Arbeitskreis Klinische Studien
• Investigators: Study Chair: Roland Schnell, MD

Publications and helpful links

General Publications

• Marschner N, Arnold D, Engel E, Hutzschenreuter U, Rauh J, Freier W, Hartmann H, Frank M, Janicke M. Oxaliplatin-based first-line chemotherapy is associated with improved overall survival compared to first-line treatment with irinotecan-based chemotherapy in patients with metastatic colorectal cancer - Results from a prospective cohort study. Clin Epidemiol. 2015 Apr 20;7:295-303. doi: 10.2147/CLEP.S73857. eCollection 2015.
• Marschner N, Frank M, Vach W, Ladda E, Karcher A, Winter S, Janicke M, Trarbach T. Development and validation of a novel prognostic score to predict survival in patients with metastatic colorectal cancer: the metastatic colorectal cancer score (mCCS). Colorectal Dis. 2019 Jul;21(7):816-826. doi: 10.1111/codi.14600. Epub 2019 Mar 18.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2006
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: May 28, 2009
• First Submitted That Met QC Criteria: May 29, 2009
• First Posted (Estimated): June 1, 2009

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Physical Activity; Epidemiology; Palliative Care; Health Services Research; Colorectal Cancer; Registry; Advanced Colorectal Cancer; Germany; Nutrition Assessment; Palliative Treatment; Adjuvant Drug Therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Behavior; Colorectal Neoplasms; Motor Activity
• Other Study ID Numbers: IOM TKK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO