Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Disease Attributes

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Cisplatin

Trabectedin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Antineoplastic Agents, Alkylating

Alkylating Agents

According to the investigator's discretion

PLD 30 mg/m² + Trabectedin 1.1 mg/m² q21

Administration according to investigator's discretion

Felix Hilpert, MD, PhD

This is an open-label, prospective, randomized, controlled, parallel group, multi-center phase III trial to evaluate the Symptom Benefit Rate of trabectedin/PLD in patients with recurrent ovarian cancer who achieve a stabilization of disease after 3 cycles of platinum-based reinduction therapy and with no clinical benefit.

Approximately 330 patients will be randomized in a 1:1 ration to the treatments specified below:

Arm A - Platinum-based chemotherapy according to investigator's discretion Arm B - Pegylated liposomal doxorubicin 30 mg/m² + Trabectedin 1.1 mg/m² (q3w)

Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer

Trabectedin/PLD Versus Continuation of Platinum-based Chemo-therapy in Patients With Disease Stabilization and no Symptom Benefit Under Platinum-based Chemotherapy for Recurrent Ovarian Cancer

Proportion of patients achieving a symptom benefit defined as an at least 10-point improvement according to EORTC QLQ-OV28; EORTC QLQ-OV28 is a questionnaire regarding Quality of Life specialized for Ovarian Cancer with points from 1 till 4 for each of the 28 questions (1=not at all, 2=a little, 3=quite a bit, 4=very much). Points will be summarized.

TUDD is defined as time from baseline until the first decrease in EORTC QLQ-C30 score ≥ 10 points (or 20 points) as compared at baseline; EORTC QLQ-C30 is a questionnaire regarding Quality of Life specialized for Cancer with points for each of the 30 questions (1=not at all, 2=a little, 3=quite a bit, 4=very much). Points will be summarized.

Progressive disease is based on investigator assessment using RECIST v1.1

RR is based on investigator assessment using RECIST v1.1

based on Quality of Life; EORTC QLQ-C30 and EORTC QLQ-OV 28 are questionnaires for Quality of Life with points for each of the 30 or 28 questions (1=not at all, 2=a little, 3=quite a bit, 4=very much). Points will be summarized.

regular patient contact during the trila regarding life status

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer	NCT03690739	Recurrent Ovari...	Carboplatin Gemcitabine Bevacizumab PLD Paclitaxel PLD Trabectedin Cisplatin	18 Years -	AGO Research GmbH
Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer	NCT03690739	Recurrent Ovari...	Carboplatin Gemcitabine Bevacizumab PLD Paclitaxel PLD Trabectedin Cisplatin	18 Years -	AGO Research GmbH
Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer	NCT03690739	Recurrent Ovari...	Carboplatin Gemcitabine Bevacizumab PLD Paclitaxel PLD Trabectedin Cisplatin	18 Years -	AGO Research GmbH

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