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Surgery

Radical Surgery + Chemotherapy Timing for Ovarian Cancer (TRUST Trial)

N/A
Waitlist Available
Led By Sven Mahner, Professor MD
Research Sponsored by AGO Study Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Suspected or histologically confirmed, newly diagnosed invasive epithelial ovarian cancer FIGO stage IIIB-IV (IV only if resectable metastasis)
Females aged ≥ 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be followed up for 1 year after surgery or until death
Awards & highlights

TRUST Trial Summary

This trial consists of three parts, which compare two strategies for timing surgery in the therapy of advanced ovarian cancer. Part 1 and 2 are only in Germany, and Part 3 is multinational.

Who is the study for?
Women over 18 with suspected or confirmed advanced ovarian cancer (stages IIIB-IV) who can undergo surgery and have a good performance status. They must not have had prior treatments for ovarian cancer, other recent cancers except certain skin or breast cancers, nor any conditions that would interfere with the study.Check my eligibility
What is being tested?
The trial is comparing two surgical timing strategies within standard chemotherapy treatment to see which one improves overall survival in advanced ovarian cancer. Patients will either receive upfront surgery followed by chemotherapy or initial chemotherapy followed by interval debulking surgery.See study design
What are the potential side effects?
Side effects may include those typical of major abdominal surgery such as pain, infection risk, bleeding, blood clots and recovery time complications. Chemotherapy side effects can range from nausea, fatigue, hair loss to more severe impacts on blood cells and organ function.

TRUST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with advanced ovarian cancer that may be operable.
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I am a woman aged 18 or older.
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My overall health is good or excellent.
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I am under 25 or have a specific biopsy result, and need tests to rule out stomach or bowel cancer.
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My white blood cell count is healthy without medical help.
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My liver is functioning well, with normal bilirubin levels.
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My nerve damage does not significantly affect my daily activities.
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A surgeon believes my tumor can be fully removed with surgery.
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My kidney function is within the normal range.
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I am fully active or restricted in physically strenuous activity but can do light work.

TRUST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be followed up for 1 year after surgery or until death
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will be followed up for 1 year after surgery or until death for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
overall survival (OS)
Secondary outcome measures
Documentation of surgical complications
Progression-free survival (PFS)
Progression-free survival 2 (PFS2)
+3 more

TRUST Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II Timing of surgery after 3 cycles of SOC CTXExperimental Treatment3 Interventions
3 cycles of standard NACT followed by IDS with maximum effort to achieve the goal of complete gross resection followed by 3 more cycles (for a total of 6) of standard chemotherapy
Group II: Arm I PDS and chemotherapyActive Control2 Interventions
PDS with maximum effort to achieve the goal of complete gross resection then followed by 6 cycles of standard chemotherapy

Find a Location

Who is running the clinical trial?

AGO Study GroupLead Sponsor
30 Previous Clinical Trials
14,946 Total Patients Enrolled
15 Trials studying Ovarian Cancer
5,807 Patients Enrolled for Ovarian Cancer
Sven Mahner, Professor MDPrincipal InvestigatorAGO Study Group

Media Library

IDS (Surgery) Clinical Trial Eligibility Overview. Trial Name: NCT02828618 — N/A
Ovarian Cancer Research Study Groups: Arm I PDS and chemotherapy, Arm II Timing of surgery after 3 cycles of SOC CTX
Ovarian Cancer Clinical Trial 2023: IDS Highlights & Side Effects. Trial Name: NCT02828618 — N/A
IDS (Surgery) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02828618 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to participate in this trial?

"Based on the information available, it appears this medical trial is no longer recruiting. This study was first posted in July 2016 and last updated January 2021. However, there are 679 other trials currently looking for volunteers at this time."

Answered by AI
~0 spots leftby Apr 2024