on-interventional study to evaluate neurotoxicity under adjuvant or palliative therapy with Oxaliplatin Omnicare for patients with colorectal carcinoma

• Conditions: MedDRA - Colorectal carcinoma (10010036); C18; Malignant neoplasm of colon

• Registration Number: DRKS00007822
• Lead Sponsor: OMNICARE Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-04
• Study Completion: 2020-03-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 179

Inclusion Criteria

1.Male and female patients = 18 years
2.Diagnosis of metastatic colorectal carcinoma for which a palliative chemotherapy is indicated or of a colon carcinoma of stage III (Dukes C) after complete resection of the primary tumor for which an adjuvant chemotherapy is indicated
3.Investigator's decision (independent of study participation) to treat the patient with Oxaliplatin Omnicare®
4.Sufficient patient's compliance upon investigator's assessment
5.Written informed consent of the patient to retrospective and prospective pseudonomized documentation, to forwarding and analysis of the data and to access to the data within monitoring

Exclusion Criteria

None

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of grade and duration of neurotoxicity for patients under therapy with Oxaliplatin Omnicare by means of a patient questionnaire

Secondary Outcome Measures

Name	Time	Method
•Evaluation of neurotoxicity by the investigator by means of CTCAE criteria (version 4.0)<br>•Evaluation of adverse drug reactions of Oxaliplatin Omnicare®<br>