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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)

Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. This ANC cannot have been induced or supported by granulocyte colony stimulating factors.

Must not have

Non-epithelial ovarian malignancies and borderline tumors

Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patients will be followed up for 1 year after surgery or until death

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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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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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My ovarian cancer is not of the common type and is considered borderline.

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I haven't had any other cancers in the last 5 years, except for certain early-stage cancers.

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My ovarian cancer has come back.

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I have had chemotherapy or radiotherapy for ovarian cancer.

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My cancer has spread to my lungs, liver, or lymph nodes and cannot be removed by surgery.

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I have issues with blood clotting, including those caused by medication.

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I am mentally capable of understanding and consenting to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients will be followed up for 1 year after surgery or until death

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

overall survival (OS)

Secondary study objectives

Documentation of surgical complications

Progression-free survival (PFS)

Progression-free survival 2 (PFS2)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 13Eligibility criteria met