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

  • STATUS
    Recruiting
  • End date
    Feb 6, 2022
  • participants needed
    204
  • sponsor
    North Eastern German Society of Gynaecological Oncology
Updated on 6 September 2021
platelet count
paclitaxel
combination therapy
carcinoma
neutrophil count
carboplatin
gemcitabine
cancer chemotherapy
fallopian tube
platinum-based chemotherapy
ovarian epithelial cancer
trabectedin
primary peritoneal carcinoma
peritoneal carcinoma
recurrent ovarian cancer
ovarian epithelial carcinoma
cancer of the ovary

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.

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.

Details
Condition Ovarian disorder, Ovarian Cancer, Quality of life, Ovarian Function, Recurrent Ovarian Carcinoma, Recurrent Ovarian Cancer, ovarian carcinomas, cancer, ovarian, cancer ovarian, cancer of the ovary, quality-of-life, ovarian tumors
Treatment No Intervention - Observational Study, Trabectidin (Yondelis)
Clinical Study IdentifierNCT03164980
SponsorNorth Eastern German Society of Gynaecological Oncology
Last Modified on6 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Women aged 18 years
Patients with histologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube cancer who received 1 prior chemotherapy
Patients must be eligible for platin-containing therapy; Patient is defined as platin-sensitive when considered for platin-containing therapy by the investigator. The time frame from end of prior therapy until disease progression alone is not pivotal for study participation. Patients without a platin-containing regimen in the previous line who are also eligible for platin-containing regime are also appropriate for participation
Eastern Cooperative Oncology Group (ECOG) performance status of 2
Adequate baseline organ function as defined as
Leucocytes > 3.0 x 109/l
Platelet count > 100 x 109/l
Absolute neutrophil count (ANC) 1500/mm3
Haemoglobin 9 g/dl
Alkaline Phosphatase (AP) 2.5 ULN (consider hepatic isoenzymes 5 nucleotidase or gamma glutamyl transpeptidase (GGT), if the elevation could be osseous in origin)
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 ULN
Creatinine-Clearance 60 ml/min (MDRD formula or Cockroft & Gault formula)
Serum creatinine 1.5 mg/dl
Creatine phosphokinase (CPK) 2.5 ULN
Total bilirubin < ULN
Women of childbearing potential should use contraceptives or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication or be surgically sterile
Adequate cardiac function defined as left ventricular ejection fraction (LVEF) 50% as determined by echocardiogram
Patients must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures

Exclusion Criteria

Only malignancies, which influence the prognosis
Any unstable or serious concurrent condition (e.g. active infection requiring systemic therapy)
Chemotherapy or radiation therapy or tumor embolization within 2 weeks prior to the first dose of study drug or planned during study participation
Patients who have refractory disease. Refractory disease is defined if relapse occurs <4 months after beginning of platin-containing therapy
Hypersensitivity to the active substance or to any of the excipients of study drug
Findings from ECG and/or assessment of LVEF which indicate an anthracycline-related cardiotoxic process which contradicts administration of liposomal doxorubicin in accordance with the requirements of the SmPC of PLD
Biological therapy, immunotherapy, hormonal therapy or treatment with an investigational agent within 14 days (for bevacizumab, 30 days) prior to the first dose of study drug
Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
Participation in another clinical study with experimental therapy within the 30 days before start of and during treatment. Participation in a non-interventional study should be discussed with sponsor and NC beforehand
Patients in a closed institution according to an authority or court decision (AMG 40, Abs. 1 No. 4)
Patients who are depending on the sponsor/CRO or investigational site as well as on the investigator
Pregnancy or lactation period, or planning to become pregnant within 7 months after the end of treatment
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note