Ovarian CancerTRUSTNCT02828618
Trial on Radical Upfront Surgery in Advanced Ovarian Cancer
A study testing PDS (Primary Debulkdung Surgery), 6 cycles of standard chemotherapy and Timing of surgery after 3 cycles of standard NACT, IDS in people with Ovarian Cancer, run by AGO Study Group at 20 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- PDS (Primary Debulkdung Surgery), 6 cycles of standard chemotherapy and Timing of surgery after 3 cycles of standard NACT, IDS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 797 participants
- Where
- 20 sitesin 8 countries
- Study dates
- Jul 2016to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected or histologically confirmed, newly diagnosed invasive epithelial ovarian cancer FIGO stage IIIB-IV (IV only if resectable metastasis)
- Females aged ≥ 18 years
- Patients who have given their written informed consent
- Good performance status (ECOG 0/1)
- Good ASA score (1/2)
- Preoperative CA 125/CEA ratio ≥ 25 (if CA-125 is elevated)*
Show all 16Show fewer
- If <25 and/or biopsy with non-serous, non-endometroid histology, esophago-gastro-duodenoscopy (EGD) and colonoscopy mandatory to exclude gastrointestinal primary cancer
- Assessment of an experienced surgeon, that based on all available information, the patient can undergo the procedure and the tumor can potentially be completely resected
- 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.
- Platelet count ≥ 100 x 109/L.
- Renal function: Serum-Creatinine ≤ 1.5 x institutional upper limit normal (ULN).
- Hepatic function:
- Bilirubin ≤ 1.5 x ULN.
- SGOT ≤ 3 x ULN
- Alkaline phosphatase ≤ 2.5 x ULN.
- Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE Grade 1.
Who cannot join
- 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.
- Recurrent ovarian cancer
- Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy
- Unresectable parenchymal lung metastasis, liver metastasis or bulky lymph-nodes in the mediastinum in CT chest and abdomen/pelvis
- Clinical relevant dysfunctions of blood clotting (including drug induced)
Show all 10Show fewer
- Any significant medical reasons, age or performance status that will not allow to perform the study procedures (estimation of investigator)
- Pregnancy
- Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
- Any reasons interfering with regular follow-up
Trial locations and contacts
20 sites in 8 countries.
20 sites in 8 countries
Germany8 sites
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Klinik für Gynäkologie
Berlin, 13353
Universitätsklinikum Carl Gustav Carus Dresden, Klinik & Poliklinik f. Frauenheilkunde & Geburtshilfe
Dresden, 01307
Kaiserswerther Diakonie; Florence-Nightingale-Hospital
Düsseldorf
Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gyn. Onkologie
Essen, 45136
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie
Hamburg, 20246
Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Klinikum der Universität München
München, 81377
Klinikum rechts der Isar, Frauen- und Poliklinik
München, 81675
Universitätsklinikum Tübingen
Tübingen
France3 sites
Institut Bergonié
Bordeaux
Hôpital Européen Georges Pompidou (HEGP)
Paris
Institute Gustave Roussy
Villejuif, 94805
Italy3 sites
European Institute of Oncology; Gynecologic Cancer Surgery
Milan
Fondazione IRCCS Istituto Nazionale Tumori - Milan
Milan
Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli
Naples
Sweden2 sites
Skane University Hospital
Lund, 22185
Karolinska University Hospital
Solna, 17176
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United Kingdom1 site
Imperial College London, Hammersmith Hospital, Surgery&Cancer
London, W12 OHS
About this study
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.
Read the detailed description
Both randomised groups are treated with surgery for complete resection following guideline recommendations and including median laparotomy, complete adhesiolysis, hysterectomy, bilateral salpingo-oophorectomy, omentectomy and (partial) resection of all affected organs (e.g. small or large bowel, peritoneum, spleen, pancreas, peritoneum, urinary tract etc.) as well as pelvic and paraaortic lymphadenectomy if indicated. Patients with significant pleural effusion (>500 mL in the right chest or any pleural effusion in the left chest, assessed either through ultrasound or CT scan) need to undergo video assisted thoracoscopy or open assessment of the pleura prior or during debulking surgery to detect and if possible remove intrathoracic disease.
Group 1: Primary debulking surgery Patients allocated to the primary debulking group undergo surgery followed by 6 cycles of platinum and taxane based chemotherapy.
Recommended systemic treatment Group 1:
It is recommended to start systemic treatment after sufficient regeneration from surgery [45], which will be ideally 2 to 6 weeks (but at the latest 8 weeks) after surgery. The following treatments are recommended:
- Participation in a prospective randomized trial, as long as participation is possible in case of randomization in either arm of the current study
- Carboplatin AUC 5-6 / paclitaxel 175 mg/m² q21 / bevacizumab 15mg/KG q21, 6 cycles followed by bevacizumab maintenance therapy for a total of 15 months or until disease progression.
- Carboplatin AUC 5-6 / paclitaxel 175 mg/m² q21, 6 cycles. Substitution of paclitaxel by docetaxel (75mg/m²) in cases of contraindications to paclitaxel is possible. Maintenance/consolidation therapy inside prospective trials or according to national standard treatments is allowed. Additional treatment outside prospective studies is not recommended.
- Carboplatin AUC 5 - 6, q21 , 6 cycles in the case of contraindications of combination chemotherapy
Group 2: Interval debulking surgery Patients allocated to the interval debulking surgery group undergo biopsy to confirm ovarian cancer and then 3 cycles of neoadjuvant preoperative platinum and taxane based chemotherapy. Then interval debulking surgery is performed followed by 3 cycles of postoperative platinum and taxane based chemotherapy
Recommended systemic treatment Group 2:
It is recommended to start systemic treatment as soon as possible after biopsy confirmation of ovarian cancer.
The following treatments are recommended for neoadjuvant chemotherapy:
- Participation in a prospective randomized trial, as long as participation is possible in case of randomization in either arm of the current study
- Carboplatin AUC5-6 / paclitaxel 175 mg/m² q21, 3 cycles. Substitution of paclitaxel by docetaxel (75mg/m²) in cases of contraindications to paclitaxel is possible.
- Carboplatin AUC 5-6, q21 , 3 cycles in the case of contraindications of combination chemotherapy
It is recommended to start postoperative chemotherapy after sufficient regeneration from interval debulking surgery, which will be ideally 2 to 6 weeks after surgery. The following treatments are recommended:
- Participation in a prospective randomized trial, as long as participation is possible in case of randomization in either arm of the current study
- Carboplatin AUC 5-6 / paclitaxel 175 mg/m² q21 / bevacizumab 15mg/KG q21, 3 cycles followed by bevacizumab maintenance therapy for a total of 15 months or until disease progression.
- Carboplatin AUC5-6 / paclitaxel 175 mg/m² q21, 3 cycles. Substitution of paclitaxel by docetaxel (75mg/m²) in cases of contraindications to paclitaxel is possible. Maintenance/consolidation therapy inside prospective trials or according to national standard treatments is allowed. Additional treatment outside prospective studies is not recommended.
- Carboplatin AUC 5-6, q21 , 3 cycles in the case of contraindications of combination chemotherapy
- Conditions
- Ovarian Cancer
- Being tested
- PDS (Primary Debulkdung Surgery), 6 cycles of standard chemotherapy, Timing of surgery after 3 cycles of standard NACT, IDS, IDS, 3 cycles of standard chemotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDS (Primary Debulkdung Surgery)Procedure or surgery
PDS with maximum effort to achieve the goal of complete gross resection
6 cycles of standard chemotherapyProcedure or surgery
6 cycles of standard chemotherapy after Primary Debuling Surgery
Timing of surgery after 3 cycles of standard NACT, IDSProcedure or surgery
Timing of surgery after 3 cycles of standard NACT
IDSProcedure or surgery
IDS with maximum effort to achieve the goal of complete gross resection after NACT
3 cycles of standard chemotherapyDrug
3 more cycles (for a total of 6) of standard chemotherapy after IDS
| Study group | Role | What they receive |
|---|---|---|
| Arm I PDS and chemotherapy | Active comparator | PDS with maximum effort to achieve the goal of complete gross resection then followed by 6 cycles of standard chemotherapy Receives: Procedure: PDS (Primary Debulkdung Surgery); Procedure: 6 cycles of standard chemotherapy |
| Arm II Timing of surgery after 3 cycles of SOC CTX | Experimental | 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 Receives: Procedure: Timing of surgery after 3 cycles of standard NACT, IDS; Procedure: IDS; Drug: 3 cycles of standard chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
To compare the overall survival (OS) after primary debulking surgery (PDS) versus interval debulking surgery (IDS) following neoadjuvant chemotherapy (NACT) in patients with FIGO (2014) stage IIIB-IVB ovarian, tubal, and peritoneal carcinoma.
The primary endpoint overall survival time is calculated from the date of randomization until the date of death from any cause or date of last contact (censored observation).
Measured: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
Secondary outcomes (6)
Progression-free survival (PFS)
Progression-free survival time is calculated from the date of randomization until the date of first progressive disease or death, whichever occurs first or date of last contact (censored observation). Progressive disease is defined as clinical or imaging-detected tumor progression or death in cases without prior documented tumor progression.
Measured: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
Progression-free survival 2 (PFS2)
PFS2 time is calculated from the date of randomization until the date of second progressive disease or death, whichever occurs first or date of last contact (censored observation).
Measured: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
Time to first subsequent anticancer therapy or death (TFST)
Time to first subsequent anticancer therapy is calculated from the date of randomization until the starting date of the first subsequent anticancer therapy or death, whichever occurs first or date of last contact (censored observation). Maintenance treatments following a cytostatic treatment are not considered separate treatment lines.
Measured: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
Time to second subsequent anticancer therapy or death (TSST)
Time to second subsequent anticancer therapy is calculated from the date of randomization until the starting date of the second subsequent anticancer therapy or death, whichever occurs first or date of last contact (censored observation). Maintenance treatments following a cytostatic treatment are not considered separate treatment lines.
Measured: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
Quality of life (QoL)
Quality of life (QoL) as measured by EORTC QLQ-C30 (Version 3), EORTC QLQ-OV28, EQ-5D-3L
Measured: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
Documentation of surgical complications
Assessment of safety: documentation of surgical complications 28 days after surgery and 1 year after surgery.
Measured: Patients will be followed up for 1 year after surgery or until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 797 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGO Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sven Mahner, Professor MD, Principal investigator, AGO Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828618
- Sponsor's protocol ID
- AGO-OVAR OP.7/TRUST
- Acronym
- TRUST
- Status last verified
- Sep 2025
- First submitted
- 30 Jun 2016
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Fumagalli D, Jayraj A, Olearo E, Capasso I, Hsu HC, Tzur Y, Piedimonte S, Jugeli B, Santana BN, De Vitis LA, Caruso G, Aletti G, Colombo N, Ramirez PT. Primary versus interval cytoreductive surgery in patients with rare epithelial or non-epithelial ovarian cancer. Int J Gynecol Cancer. 2025 Mar;35(3):101664. doi: 10.1016/j.ijgc.2025.101664. Epub 2025 Jan 28.
PubMed 40022844Reuss A, du Bois A, Harter P, Fotopoulou C, Sehouli J, Aletti G, Guyon F, Greggi S, Mosgaard BJ, Reinthaller A, Hilpert F, Schade-Brittinger C, Chi DS, Mahner S. TRUST: Trial of Radical Upfront Surgical Therapy in advanced ovarian cancer (ENGOT ov33/AGO-OVAR OP7). Int J Gynecol Cancer. 2019 Oct;29(8):1327-1331. doi: 10.1136/ijgc-2019-000682. Epub 2019 Aug 15.
PubMed 31420412
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial on Radical Upfront Surgery in Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02828618
- Acronym / sponsor ID
- TRUST / AGO-OVAR OP.7/TRUST
- Conditions
- Ovarian Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 797 participants (actual)
- Lead sponsor
- AGO Study GroupUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Feb 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Both randomised groups are treated with surgery for complete resection following guideline recommendations and including median laparotomy, complete adhesiolysis, hysterectomy, bilateral salpingo-oophorectomy, omentectomy and (partial) resection of all affected organs (e.g. small or large bowel, peritoneum, spleen, pancreas, peritoneum, urinary tract etc.) as well as pelvic and paraaortic lymphadenectomy if indicated. Patients with significant pleural effusion (>500 mL in the right chest or any pleural effusion in the left chest, assessed either through ultrasound or CT scan) need to undergo video assisted thoracoscopy or open assessment of the pleura prior or during debulking surgery to detect and if possible remove intrathoracic disease.
Group 1: Primary debulking surgery Patients allocated to the primary debulking group undergo surgery followed by 6 cycles of platinum and taxane based chemotherapy.
Recommended systemic treatment Group 1:
It is recommended to start systemic treatment after sufficient regeneration from surgery [45], which will be ideally 2 to 6 weeks (but at the latest 8 weeks) after surgery. The following treatments are recommended:
- Participation in a prospective randomized trial, as long as participation is possible in case of randomization in either arm of the current study
- Carboplatin AUC 5-6 / paclitaxel 175 mg/m² q21 / bevacizumab 15mg/KG q21, 6 cycles followed by bevacizumab maintenance therapy for a total of 15 months or until disease progression.
- Carboplatin AUC 5-6 / paclitaxel 175 mg/m² q21, 6 cycles. Substitution of paclitaxel by docetaxel (75mg/m²) in cases of contraindications to paclitaxel is possible. Maintenance/consolidation therapy inside prospective trials or according to national standard treatments is allowed. Additional treatment outside prospective studies is not recommended.
- Carboplatin AUC 5 - 6, q21 , 6 cycles in the case of contraindications of combination chemotherapy
Group 2: Interval debulking surgery Patients allocated to the interval debulking surgery group undergo biopsy to confirm ovarian cancer and then 3 cycles of neoadjuvant preoperative platinum and taxane based chemotherapy. Then interval debulking surgery is performed followed by 3 cycles of postoperative platinum and taxane based chemotherapy
Recommended systemic treatment Group 2:
It is recommended to start systemic treatment as soon as possible after biopsy confirmation of ovarian cancer.
The following treatments are recommended for neoadjuvant chemotherapy:
- Participation in a prospective randomized trial, as long as participation is possible in case of randomization in either arm of the current study
- Carboplatin AUC5-6 / paclitaxel 175 mg/m² q21, 3 cycles. Substitution of paclitaxel by docetaxel (75mg/m²) in cases of contraindications to paclitaxel is possible.
- Carboplatin AUC 5-6, q21 , 3 cycles in the case of contraindications of combination chemotherapy
It is recommended to start postoperative chemotherapy after sufficient regeneration from interval debulking surgery, which will be ideally 2 to 6 weeks after surgery. The following treatments are recommended:
- Participation in a prospective randomized trial, as long as participation is possible in case of randomization in either arm of the current study
- Carboplatin AUC 5-6 / paclitaxel 175 mg/m² q21 / bevacizumab 15mg/KG q21, 3 cycles followed by bevacizumab maintenance therapy for a total of 15 months or until disease progression.
- Carboplatin AUC5-6 / paclitaxel 175 mg/m² q21, 3 cycles. Substitution of paclitaxel by docetaxel (75mg/m²) in cases of contraindications to paclitaxel is possible. Maintenance/consolidation therapy inside prospective trials or according to national standard treatments is allowed. Additional treatment outside prospective studies is not recommended.
- Carboplatin AUC 5-6, q21 , 3 cycles in the case of contraindications of combination chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I PDS and chemotherapy | Active comparator | Procedure: PDS (Primary Debulkdung Surgery), Procedure: 6 cycles of standard chemotherapyPDS with maximum effort to achieve the goal of complete gross resection then followed by 6 cycles of standard chemotherapy |
| Arm II Timing of surgery after 3 cycles of SOC CTX | Experimental | Procedure: Timing of surgery after 3 cycles of standard NACT, IDS, Procedure: IDS, Drug: 3 cycles of standard chemotherapy3 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- suspected or histologically confirmed, newly diagnosed invasive epithelial ovarian cancer FIGO stage IIIB-IV (IV only if resectable metastasis)
- Females aged ≥ 18 years
- Patients who have given their written informed consent
- Good performance status (ECOG 0/1)
- Good ASA score (1/2)
Key exclusion criteria (10 listed)
- 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.
- Recurrent ovarian cancer
- Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy
- Unresectable parenchymal lung metastasis, liver metastasis or bulky lymph-nodes in the mediastinum in CT chest and abdomen/pelvis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDS (Primary Debulkdung Surgery)PDS with maximum effort to achieve the goal of complete gross resection | Procedure or surgery | Arm I PDS and chemotherapy |
| 6 cycles of standard chemotherapy6 cycles of standard chemotherapy after Primary Debuling Surgery | Procedure or surgery | Arm I PDS and chemotherapy |
| Timing of surgery after 3 cycles of standard NACT, IDSTiming of surgery after 3 cycles of standard NACT | Procedure or surgery | Arm II Timing of surgery after 3 cycles of SOC CTX |
| IDSIDS with maximum effort to achieve the goal of complete gross resection after NACT | Procedure or surgery | Arm II Timing of surgery after 3 cycles of SOC CTX |
| 3 cycles of standard chemotherapy3 more cycles (for a total of 6) of standard chemotherapy after IDS | Drug | Arm II Timing of surgery after 3 cycles of SOC CTX |
Primary outcome
overall survival (OS)
Time frame: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
To compare the overall survival (OS) after primary debulking surgery (PDS) versus interval debulking surgery (IDS) following neoadjuvant chemotherapy (NACT) in patients with FIGO (2014) stage IIIB-IVB ovarian, tubal, and peritoneal carcinoma. The primary endpoint overall survival time is calculated from the date of randomization until the date of death from any cause or date of last contact (censored observation).
6 secondary outcomes
Progression-free survival (PFS)
Time frame: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
Progression-free survival 2 (PFS2)
Time frame: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
Time to first subsequent anticancer therapy or death (TFST)
Time frame: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
Time to second subsequent anticancer therapy or death (TSST)
Time frame: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
Quality of life (QoL)
Time frame: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
Documentation of surgical complications
Time frame: Patients will be followed up for 1 year after surgery or until death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Derived from this study: PubMed 40022844Fumagalli D, Jayraj A, Olearo E, Capasso I, Hsu HC, Tzur Y, Piedimonte S, Jugeli B, Santana BN, De Vitis LA, Caruso G, Aletti G, Colombo N, Ramirez PT. Primary versus interval cytoreductive surgery in patients with rare epithelial or non-epithelial ovarian cancer. Int J Gynecol Cancer. 2025 Mar;35(3):101664. doi: 10.1016/j.ijgc.2025.101664. Epub 2025 Jan 28.
- Derived from this study: PubMed 31420412Reuss A, du Bois A, Harter P, Fotopoulou C, Sehouli J, Aletti G, Guyon F, Greggi S, Mosgaard BJ, Reinthaller A, Hilpert F, Schade-Brittinger C, Chi DS, Mahner S. TRUST: Trial of Radical Upfront Surgical Therapy in advanced ovarian cancer (ENGOT ov33/AGO-OVAR OP7). Int J Gynecol Cancer. 2019 Oct;29(8):1327-1331. doi: 10.1136/ijgc-2019-000682. Epub 2019 Aug 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sven Mahner, Professor MD principal investigator
AGO Study Group
20 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDS (Primary Debulkdung Surgery), 6 cycles of standard chemotherapy and Timing of surgery after 3 cycles of standard NACT, IDS in people with Ovarian Cancer, run by AGO Study Group at 20 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Germany, France, Italy, Sweden, United States and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS) (time frame: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02828618, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.