Comparison of QoL Between Trabectedin/PLD and Standard Platinum-based Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer

Phase 4

Completed

• Conditions: Recurrent Ovarian Carcinoma; Quality of Life; Ovarian Cancer
• Interventions: Drug: Trabectidin (Yondelis)

• Registration Number: NCT03164980
• Lead Sponsor: North Eastern German Society of Gynaecological Oncology

Brief Summary

This is a multicenter, randomized, controlled, open-label study including patients with recurrent, platinum-sensitive, ovarian, peritoneal or fallopian tube cancer.

The main scope of the trial is to evaluate QoL during chemotherapy comparing trabectedin/PLD with other standard platinum-based chemotherapy in platinum-sensitive disease.

Detailed Description

This is a multicenter, randomized, controlled, open-label study including patients with recurrent, platinum-sensitive, ovarian, peritoneal or fallopian tube cancer.

The main scope of the trial is to evaluate QoL during chemotherapy comparing trabectedin/PLD with other standard platinum-based chemotherapy in platinum-sensitive disease.

Patients with recurrent, platinum-sensitive, ovarian, fallopian tube and peritoneal cancer will be stratified according to surgery for relapse (R0 vs. R1/2 resection) vs. no surgery in the same setting and age (\< 75 years vs. ≥ 75 years), and randomized 1:1 to receive either trabectedin/PLD (Arm A) or one of 3 platinum-based standard therapies without bevacizumab (Arm B, "other standard therapy"). In case of randomization to "other standard therapy", the investigator has the choice between carboplatin/PLD, carboplatin/gemcitabine and carboplatin/paclitaxel. Patients in both treatment arms will receive chemotherapy up for 6 cycles or until disease progression (PD), unacceptable toxicities or patient's wish to stop therapy, whichever occurs first.

Study Timeline

• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-22
• Study First Posted: 2017-05-24
• Study Start: 2017-11-27
• Status Verified: 2022-04
• Primary Completion: 2023-08-08
• Study Completion: 2023-08-08
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Trabectidin (Yondelis)	PLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression.
Arm B	Trabectidin (Yondelis)	* Carboplatin/PLD * Carboplatin/Gemcitabine * Carboplatin/Paclitaxel Patients will be treated for 6 cycles or until PD, unacceptable toxicity or patient's wish to discontinue, whichever occurs first.

Primary Outcome Measures

Name	Time	Method
observation of change in QoL	3 month	QoL change from baseline (C1 D1) to after 3 months (± 2 week) or at progression, whichever occurs first. (EORTC QLQ-C30 in combination with EORTC QLQ-ov28)

Secondary Outcome Measures

Name	Time	Method
Overall survival	18 month
Progression-free survival	18 month
Difference in QoL	12 month	measured at day one of every treatment cycle, at the end of the treatment and after 6 and 12 month (follow up) (EORTC QLQ-C30 in combination with EORTC QLQ-ov28).

Trial Locations

Locations (21)

Studien GbR Braunschweig; 🇩🇪 Braunschweig, Germany

Universitätsfrauenklinik Leipzig; 🇩🇪 Leipzig, Germany

Sankt Gertrauden-Krankenhaus; 🇩🇪 Berlin, Germany

Sana Klinikum Offenbach; 🇩🇪 Offenbach, Germany

Praxis Krebsheilkunde für Frauen; 🇩🇪 Berlin, Germany

Medizinisches Zentrum Bonn Friedensplatz; 🇩🇪 Bonn, Germany

ZAGO am Helios Klinikum Krefeld; 🇩🇪 Krefeld, Germany

Caritas Klinikum St. Theresia; 🇩🇪 Saarbrücken, Germany

Christliches Klinikum Unna gGmbH; 🇩🇪 Unna, Germany

Krankenhaus Nordwest gGmbH; 🇩🇪 Frankfurt, Germany

Universitätsklinik der Johannes Gutenberg-Universität Mainz; 🇩🇪 Mainz, Germany

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum; 🇩🇪 Berlin, Germany

Universitätsklinikum Brandenburg an der Havel; 🇩🇪 Brandenburg an der Havel, Germany

Onkologische Schwerpunktpraxis; 🇩🇪 Dresden, Germany

Ruppiner Kliniken GmbH; 🇩🇪 Neuruppin, Germany

Städtisches Klinikum Dessau; 🇩🇪 Dessau-Roßlau, Germany

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany

Frauenklinik Carl Gustav Carus; 🇩🇪 Dresden, Germany

Krankenhaus Saarlouis vom DRK; 🇩🇪 Saarlouis, Germany

Klinikum Südstadt Rostock; 🇩🇪 Rostock, Germany

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Germany