Trial on radical upfront surgery in advanced ovarian cancer in Germany extended part for fragility and long term quality of life

• Conditions: C56; Malignant neoplasm of ovary

• Registration Number: DRKS00010785
• Lead Sponsor: AGO Research GmbH / AGO-Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-05
• Study Completion: 2021-08-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 444

Inclusion Criteria

First and second part of the study:
•Suspected invasive or histologically confirmed, primary epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma. Cytological diagnosis and/or biopsy before study participation are allowed.
•Signed written informed consent obtained prior to registration.
•Females aged = 18 years
•Suspected FIGO stage IIB - IVB (all grades and all histological types)

Exclusion Criteria

First and second part of the study:
•Malignancy of non-epithelial origin of the ovary, the fallopian tube or the peritoneum.
•Borderline tumours (tumours of low malignant potential) and FIGO stage IA – IIA tumours
•Recurrent ovarian cancer.
•Definitive cytoreductive surgery prior to signed informed consent.
•Prior systemic antineoplastic therapy for ovarian cancer (for example chemotherapy, monoclonal antibody therapy, tyrosine-kinase-inhibitor therapy and/or hormonal therapy).
•Dementia or significantly altered mental status, that would prohibit the understanding and giving of informed consent
•Pregnancy
•Any reasons interfering with regular follow-up.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First partFragile Study:<br>Primary endpoint: <br>Evaluation of factors to describe the cohort of patients who may not benefit from surgery and chemotherapy (? cure or at least platinum sensitive relapse, defined as no progression within 10 months after registration/randomization) as defined in section sample size calculation/statistical analysis (candidates for predictors).<br><br>Second part Quality of Life Study:<br>Primary endpoint: <br>Long term Quality of Life (QoL) assessed by EORTC QLQ-C30 and QLQ-OV28 (including functional and symptom scales) to describe the influence of treatment and course of disease on quality of life.<br>

Secondary Outcome Measures

Name	Time	Method
not defined - none