Radical Surgery + Chemotherapy Timing for Ovarian Cancer

(TRUST Trial)

Not currently recruiting at 22 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates the optimal timing for surgery and chemotherapy in treating advanced ovarian cancer. It compares two approaches: starting with surgery (Primary Debulking Surgery, PDS) followed by chemotherapy, or beginning with chemotherapy and then surgery (Interval Debulking Surgery, IDS). The goal is to determine if one method leads to better survival outcomes. Women who may qualify for this trial are those with newly diagnosed advanced ovarian cancer that a surgeon believes can be completely removed. As an unphased trial, this study allows participants to contribute to valuable research that could enhance treatment strategies for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown varying safety results for the treatments tested in this trial. Research indicates that interval debulking surgery (IDS) can reduce the risk of certain complications, such as heart problems and infections at the surgery site, compared to primary debulking surgery (PDS).

While effective, primary debulking surgery (PDS) can lead to complications. One study found that patients might experience issues within 30 days after surgery. However, these risks are balanced by benefits like longer periods without cancer progression.

Standard chemotherapy, often used with these surgeries, generally has a good safety record. Platinum-based chemotherapy is common and considered safe for many patients, even during pregnancy. However, it can have side effects typical of cancer treatments.

Overall, extensive research has provided a good understanding of these treatments' safety. Individual experiences can vary, so discussing any concerns with healthcare providers is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the optimal timing of surgery in ovarian cancer treatment. Typically, treatment involves either primary debulking surgery (PDS) followed by chemotherapy or neoadjuvant chemotherapy (NACT) before surgery. This trial investigates whether delaying surgery until after three cycles of chemotherapy could improve outcomes. By potentially enhancing surgical effectiveness and reducing tumor burden before surgery, this approach might offer a new pathway to achieving complete tumor removal and better patient outcomes.

What evidence suggests that this trial's treatments could be effective for advanced ovarian cancer?

Research has shown that both primary debulking surgery (PDS) and interval debulking surgery (IDS) offer similar long-term survival rates for advanced ovarian cancer. In this trial, participants in Arm I will undergo PDS followed by six cycles of standard chemotherapy. One study found that the average survival time for PDS was 63.1 months. Participants in Arm II will receive three cycles of standard neoadjuvant chemotherapy (NACT), followed by IDS and then three more cycles of standard chemotherapy. IDS had a slightly lower average survival time of 55.6 months, but it can result in fewer complications after surgery. For chemotherapy, standard treatments like carboplatin are as effective as other similar drugs. These treatments help shrink tumors and improve survival. Overall, both surgical options and standard chemotherapy show promise in effectively treating advanced ovarian cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Sven Mahner, Professor MD

Principal Investigator

AGO Study Group

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12427705/

Trends in Surgical Outcomes and Overall Survival Among ... This large retrospective database study shows the real-world impact of these changes in the management of advanced epithelial ovarian cancer.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5560

Consistent data about the predictive factors of the success ... Consistent data about the predictive factors of the success of interval debulking surgery (CC0-IDS) in patients with advanced ovarian cancers in ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40319362/

Comparison of clinical and cost outcomes between primary ... The thirty-day cost and ten-year survival of IDS and PDS are comparable. Although IDS offers lower postoperative sepsis and gastrointestinal ...

4. ajog.org ajog.org/article/S0002-9378(24)00818-4/fulltext

Survival outcomes of primary vs interval cytoreductive ... The median overall survival was 63.1 months (interquartile range, 61.7–65.4) for primary cytoreductive surgery in comparison with 55.6 months ( ...

5. ejgo.org ejgo.org/DOIx.php?id=10.3802/jgo.2025.36.e61

The prognosis impact of NACT-IDS and PDS in advanced ... NACT-IDS effectively enhances the satisfactory tumor reduction rate, especially for patients with stage IIIC and IV, and decreases postoperative complications.

6. ejgo.org ejgo.org/search.php?where=aview&id=10.3802/jgo.2025.36.e61&code=1114JGO&vmode=FULL

The prognosis impact of NACT-IDS and PDS in advanced ... NACT-IDS effectively reduced the risk of adverse cardiac events (OR=0.36; 95% CI=0.17 to 0.80; p=0.012), surgical site infections (OR=0.42; 95% ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0090825822005431

Optimal timing of interval debulking surgery for advanced ... Interval debulking surgery is recommended after 3–4 cycles (standard IDS) of neoadjuvant chemotherapy (NACT) for epithelial ovarian cancer (EOC)

8. esmoopen.com esmoopen.com/article/S2059-7029(24)01322-X/fulltext

46MO What are the predictors of the success of interval ... Over 50% of advanced epithelial ovarian cancer patients undergo neoadjuvant chemotherapy (NACT), aiming to achieve a complete interval debulking surgery (IDS).