Interdisciplinary patient-centred care with quality control within palliative therapy of colorectal carcinoma (IVOPAK II) A Treatment path based on the Guidelines- Personalized therapy of colorectal cancer (CRC) with region-wide controll supply

Recruiting

• Conditions: Metastatic Colorectal Cancer; C18; Malignant neoplasm of colon

• Registration Number: DRKS00011856
• Lead Sponsor: niversitätsklinikum Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

ECOG-index: 0-1: Age > 18 years <= 75 years
ECOG-index: 2: Age < 70 years

existence of all-RAS-Status (certified pahology)

patients with definitively non-resectable
distant metastases of a CRC defined by the
interdisciplinary tumour-board of Surgical
Hospital Erlangen, and presentation there

histological assurance of an adeno-carcinoma
of the colon (> 16 cm from anocutaneous line)
or of the rectum with non-resectable distant
metastases (synchronous or metachronous)

palliative chemonaive patients related to first-
line therapy, adjuvant therapy CT/neoadjuvant
RT-CT before >= 6 months allowed

negative pregnancy test of premenopauseal
women

Patient signed written consent

Exclusion Criteria

- missing patient written consent

- e.g. contra-indication against cetuximab,
bevacizumab or another therapy Option

- age: < 18 years > 75 years

- ECOG-index 2: age > 75 years

- no initial presentation at an interdisciplinary
tumour-board with regard to non-resectability
of the distant metastases

- no adequate contraception for premenopauseal
women

- pregnancy and lactation

- MSI-tumors (immunohistochemical)

- BRAF-V600E-mutation in tumor

- Appendix adenocarcinoma

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
implementation of the interdisciplinary tumour board recommandations

Secondary Outcome Measures

Name	Time	Method
Overall survival; frequency and success of secondary metastatic resection with detection of morbidity and mortality andlLong-term survival time