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)

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) - SCORE trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011344

Enrollment

500

Registered

2016-11-21

Start date

2016-08-15

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C56

Interventions

Group 1: Patients suffering from reccurend ovarian cancer are treated with treosulfan in a non-interventional trial. As treosulfan is approved and can be administered in an intravenous and an oral for

Journal of Cancer Research and Clinical Oncology in press] before starting the treatment, Patients answer questionaries concerning cancer realted questtions (MOST questionary), therapyexpierience and

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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)).	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactInsa Wolf

medac Gesellschaft für klinische Spezialpräparate mbH

i.wolf@medac.de+49 4103 8006 9479

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026