Identifikation of parameters for the development of a Score to predict the non-compliance of patients with recurrent ovarian cancer undergoing a routine therapy with Ovastat(R).A non-interventional observation trial (NIS)

Completed

• Conditions: C56; Malignant neoplasm of ovary

• Registration Number: DRKS00011344
• Lead Sponsor: medac Gesellschaft für klinische Spezialpräparate mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-21
• Study Completion: 2023-11-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 194

Inclusion Criteria

patients with recurrent ovarian cancer who have decided to undergo a chemotherapy with treosulfan
- patients aged 18 years or older
- patients who are able to answer questionaires in german language
- willingness to answer questionaires
- before entering the trial informed consent and data privacy statement must be signed by the patient

Exclusion Criteria

contemporaneous partizipation in a different clinical trial during the time of treatment or within the last 30 days.
- hypersensitivity to treosulfan
- patients with missing or reduced legal competence
- patients in an instituion due to a legal or governmental order
- pregnant and breast-feeding women
- no anamnesis form (contains only data collected in routine anamnesis)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identifikation of parameters for the development of a Score to predict the non-compliance of patients with recurrent ovarian cancer undergoing a routine therapy with treosulfan (Ovastat(R)).<br>

Secondary Outcome Measures

Name	Time	Method
evalution of preference for a i.v. or oral therapy and reasons for the decision<br>- dose intensity and duration of treatment<br>- reasons for therapy discontinuation and dose modification<br>- tolerability<br>- concurrent medication<br>- influence of comarbidity and age on therapy efficacy and and intensity<br>- determination of objective response (PR+CR) and clinical Benifit (CR+PR+SD)<br>- median progressiondree Survival (PFS) <br>- PFS rate after one year<br>- Time to treatment failure (TTF)<br>- one Year survival rate<br>- Subgroup analyses: age <65 and age>65<br>- previous and subsequent therapies<br>- relation beteween Therapy compliance and efficacy