Clinical trial NCT00910819: Tumour Registry Colorectal Cancer
Official title: Prospective and Retrospective Observation of the Adjuvant and Palliative Treatment Strategies in the Therapy of Colorectal Cancer in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Advanced Colorectal Cancer
Epidemiology
Health Services Research
Germany
Registry
Palliative Care
Palliative Treatment
Adjuvant Drug Therapy
Nutrition Assessment
Physical Activity
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: Arbeitskreis Klinische Studien
name: Arbeitsgemeinschaft fur Internistische Onkologie
First posted: 2009-06-01
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colorectal cancer patients undergoing antineoplastic treatment.

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

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.

Eligibility criteria: Inclusion Criteria:

* Colorectal cancer
* 18 years and older
* Antineoplastic treatment

Exclusion Criteria:

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

Primary outcomes:
measure: Course of Antineoplastic Treatment
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: iOMEDICO AG
state: BW
Study officials:
name: Roland Schnell, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.