Author Archives: Rosa Kutz

NOGGO S15 – FraStROC

NOGGO S15 - FraStROC

Study for patients with recurrent or relapsed ovarian cancer.

STUDY FOR PATIENTS WITH RECURRENT OR RELAPSED OVARIAN CANCER

The FraStROC study is a non-interventional, prospective, multicenter observational study in which the frailty and fragility of ovarian cancer patients in the recurrence situation during chemotherapy is evaluated. The study is being conducted in two phases.

What is the aim of the study?
The aim of the study is to prospectively evaluate inflammatory markers, organ dysfunction, functional tests and geriatric assessment measures and patient-reported outcome for their ability to predict hematologic toxicity or non-hematologic toxicity.

What is the procedure for the study?
This is a prospective, multicenter, non-interventional, observational study in 2 stages for patients with epithelial ovarian cancer or carcinosarcoma (EOC), fallopian tube cancer (FTC) or primary peritoneal cancer (PPC) who require monotherapy for recurrent disease and have participated in at least one prior systemic treatment.

Steps 1 and 2:
In the study, demographic, clinical and pathological aspects of the patients are assessed, the measures taken before the start of chemotherapy are documented and an assessment of toxicity is carried out for one year from the start of treatment (follow-up).
In the first step of the study, a frailty score is to be determined on the basis of the data collected in order to estimate the probability that chemotherapy will have to be discontinued due to side effects. In the second step of the study, the calculated score will be tested (validated).

Are there any risks?
No, it is an observational study.

PARTICIPATION REQUIREMENTS

Can I take part in this study?
Most important inclusion and exclusion criteria:

Patients must submit a written declaration of consent in advance and be at least 18 years old:

have a histologically confirmed diagnosis of epithelial ovarian cancer, carcinosarcoma, primary peritoneal cancer or fallopian tube cancer
have a recurring cancer
are eligible for monochemotherapy with paclitaxel, doxorubicin (PLD), topotecan or treosulfan with optional use of bevacizumab
have received at least one previous treatment regimen for ovarian cancer (permitted from the second line of treatment)
have a life expectancy of at least 12 weeks.

Ineligible patients:
Patients are excluded if:

they are only eligible for combination chemotherapy or maintenance therapy after previous chemotherapy or radiotherapy is planned.

In addition, there are further criteria that must be met. Interested patients should speak to an investigator at a study center who can check whether they are eligible for this study.

ARE YOU INTERESTED IN THE STUDY?
Please contact your medical team (gynecologist or oncologist) with this PDF. They will check whether the study is suitable for you and refer you to a study center.

AGO-OVAR 28 / ENGOT-OV57

AGO-OVAR 28 / ENGOT-ov57

A randomized open-label phase III study evaluating niraparib alone versus the combination of niraparib and bevacizumab in patients receiving chemotherapy for newly diagnosed advanced ovarian cancer

What is the aim of the study?

Two large global studies in patients with newly diagnosed advanced ovarian, fallopian tube or primary peritoneal cancer have shown that the time to recurrence is prolonged when patients who have responded to previous platinum-containing chemotherapy receive maintenance treatment with a PARP inhibitor following chemotherapy. One study investigated the effect of niraparib alone; the other the effect of olaparib in combination with bevacizumab. This raises the question of whether maintenance therapy with a PARP inhibitor alone is sufficient or whether a combination with bevacizumab is necessary. The aim of this clinical trial is therefore to find out whether chemotherapy in combination with bevacizumab followed by maintenance therapy with bevacizumab and niraparib is more effective than chemotherapy followed by maintenance therapy with niraparib alone.

What is the procedure for the study?

This study is being conducted at around 200 trial sites worldwide; a total of around 970 patients are expected to take part.

If the patient decides to take part in the study, a declaration of consent must be signed. Various inclusion and exclusion criteria are used to check whether the patient is suitable for participation in the study.

If the patient is a suitable candidate for the study, she will start the first cycle of chemotherapy with carboplatin and paclitaxel as part of the study. At the same time, the patient’s existing tumor samples are tested for a BRCA mutation.

If the tumor sample is evaluable, a result is available before the 2nd cycle of chemotherapy and the patient is still suitable for participation, the patient will be assigned to one of the treatment arms listed below.

Treatment arm 1: The patient receives 5 further cycles of chemotherapy with paclitaxel and carboplatin and, after the end of chemotherapy, niraparib in the form of capsules to be taken daily for up to 3 years.

Treatment arm 2: The patient receives 5 further cycles of chemotherapy with paclitaxel and carboplatin as well as bevacizumab. After the end of chemotherapy, you will receive bevacizumab every 3 weeks for up to 1 year and niraparib as a capsule once a day for up to 3 years.

During chemotherapy and in the first year of maintenance therapy with niraparib (+/- bevacizumab), patients are called in for a study visit at the trial center every three weeks. Subsequently, these visits will take place every 12 weeks in the 2nd and 3rd year of maintenance therapy.

After completing treatment, patients are called in for a check-up and then for follow-up appointments every 3 months.

Are there any risks?

You will be informed about possible risks and side effects associated with participation during an information session.

Conditions of participation

This study is open to women aged 18 and over who:

are suffering from a newly diagnosed primary, advanced high grade epithelial ovarian, fallopian tube or primary peritoneal cancer with FIGO stage III/IV
have recently had tumor removal surgery or are scheduled to have tumor removal surgery during the course of their treatment

can provide paraffin-embedded tumor tissue

have an ECOG performance status (quality of life index of the Eastern Cooperative Oncology Group) of 0-1
with adequate organ and bone marrow function and normal blood pressure
are willing and able to participate in the study visits and understand all study-related procedures

However, there are also other criteria that must be met in order to participate in the study. Interested patients should speak to the investigators at a study center, who can check whether this study is suitable for them.

Last updated on 29.01.2025

EXPRESSION XX (20)

NOGGO S33/ Expression XX (20)

SURVEY AMONG PATIENTS WITH GYNECOLOGICAL TUMORS ON HOW TO DELIVER BAD NEWS

Breaking bad news is an essential part of everyday medical practice, especially in gynecologic oncology. Despite the frequency of these conversations, breaking bad news is a considerable challenge for many doctors.

Studies emphasize the need for communication training in order to strengthen the self-confidence of medical staff and reduce the fear of such conversations. To date, however, there have been few studies on this topic, especially in German-speaking countries, which record the perspective of patients when breaking bad news in gynecological oncology. To close this gap, the Expression 20 survey was planned.

What is the aim of the survey?

The aim of this survey is to record and analyze the perspective of female patients when delivering bad news. Differences between women with and without a migration background will be examined. It is assumed that female patients generally see a need for improvement when breaking bad news. In addition, research is to be conducted into whether women with a migration background feel less well informed compared to women without a migration background and whether they have a need for intercultural skills and services.

What is the survey process?

A total of 500 patients will be surveyed for the study. The survey is anonymous and the data will be collected using a questionnaire, which will be available in paper form at the participating study centers. The questionnaire is available in 4 languages – German, Turkish, Arabic and English.

The questionnaire is divided into 2 parts:

Socio-demographic questions:
15 questions about the person (age, educational status, partnership, mother tongue, place of birth) and the tumor disease
Interview questions:
46 Questions about a conversation in which bad news about the illness was communicated. The questions relate in particular to the patient’s condition and wishes during this conversation and the time after the conversation.

Are there any risks?

Expression 20 is a survey study and therefore has no participation risks.

Participation requirements

Women with gynecological-oncological tumor diseases including borderline tumors may participate in this survey. The minimum age is 18 years. Only women living in Germany are included.

Where can I take part in the survey?

The study is currently being conducted in Berlin at the Department of Gynecology at Charité’s Virchow Clinic and at Vivantes Klinikum am Urban.

Participation is now also possible online possible!

This study is supported by:

Page last updated on: 23.01.2026