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

Trial on radical upfront surgery in advanced ovarian cancer in Germany extended part for fragility and long term quality of life - AGO-OVAR 19

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00010785

Enrollment

440

Registered

2016-07-05

Start date

2016-08-16

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: First part – Fragile Study: There are no specific study related interventions. Surgery and/or Systemic therapy are up to investigators discretion according to national German guidelines and

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
First partFragile Study: Primary endpoint: 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). Second part Quality of Life Study: Primary endpoint: 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.	—

Measure

Time frame

First partFragile Study: Primary endpoint: 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). Second part Quality of Life Study: Primary endpoint: 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.

—

Secondary

Measure	Time frame
not defined - none	—

Countries

Germany

Contacts

Public ContactGabriele Elser

AGO Research GmbH / AGO -Study Group

office-wiesbaden@ago-ovar.de+49(0)611-8804670

Outcome results

None listed

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