Radical Surgery + Chemotherapy Timing for Ovarian Cancer

(TRUST Trial)

Recruiting at 19 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: AGO Study Group

Disqualifiers: Non epithelial ovarian malignancies, Secondary invasive neoplasms, Recurrent ovarian cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

797 Participants Needed

Trial Summary

What is the purpose of this trial?

This study consists of three parts, whereas Part 1 and Part 2 are performed in Germany only, and Part 3 is a multinational trial. All patients with suspicion of advanced ovarian cancer are detected in the participating study centers in a pre-screening. The study centers will register all patients with suspected ovarian cancer in a screening log. After the patients have given informed consent, they can be enrolled in different parts of the study. TRUST-Trial: This part compares two strategies in the therapy of advanced ovarian cancer. En detail, this part of the trial will evaluate if one of two strategies of timing surgery within the therapeutic procedures may show any significant advances in terms of overall survival over the other.

Research Team

Sven Mahner, Professor MD

Principal Investigator

AGO Study Group

Eligibility Criteria

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.

Inclusion Criteria

Patients who have given their written informed consent

Your SGOT level in the blood is not more than 3 times the normal upper limit.

I have been diagnosed with advanced ovarian cancer that may be operable.

Exclusion Criteria

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

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

My ovarian cancer has come back.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Primary Debulking Surgery and Chemotherapy

Patients undergo primary debulking surgery followed by 6 cycles of platinum and taxane-based chemotherapy

18-24 weeks

Interval Debulking Surgery and Chemotherapy

Patients undergo biopsy, 3 cycles of neoadjuvant chemotherapy, interval debulking surgery, and 3 cycles of postoperative chemotherapy

18-24 weeks

Follow-up

Participants are monitored for overall survival and progression-free survival

Minimum of 5 years

Treatment Details

Interventions

• IDS
• PDS (Primary Debulkdung Surgery)
• Standard Chemotherapy

Trial Overview 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.

Participant Groups

Group I: Arm II Timing of surgery after 3 cycles of SOC CTX Experimental Treatment 3 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 chemotherapy Active Control 2 Interventions

PDS with maximum effort to achieve the goal of complete gross resection then followed by 6 cycles of standard chemotherapy

Who Is Running the Clinical Trial?

AGO Study Group

Lead Sponsor

Trials

31

Recruited

15,800+