Ovarian CancerMISSION-2NCT07031908
Minimally Invasive Interval Debulking Surgery in Advanced Ovarian Cancer
An observational study of Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
In women with advanced epithelial ovarian cancer (AOC), neoadjuvant chemotherapy (NACT) combined with interval cytoreductive surgery and post-operative chemotherapy is an option. 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?
- Minimally invasive cytoreduction
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2025to 15 Jun 2029
- Phase
- Observational
- 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
Study population: All patients diagnosed with primary advanced epithelial ovarian cancer, FIGO stage III-IV not candidate for primary debulking surgery at diagnosis or after III-IV cycles of neoadjuvant chemotherapy.
Who may be able to join
- Stage IIIC or IV high-grade invasive epithelial ovarian carcinoma (serous, endometrioid, clear cell, transitional), primary peritoneal carcinoma, or fallopian tube carcinoma, or pathology consistent with high-grade Müllerian carcinoma.
- Partial or complete radiological response of abdominal cavity disease after at least 6 cycles of neoadjuvant chemotherapy (NACT).
- CA125 < 100 U/mL.
- ECOG performance status 0-1.
- Signed informed consent and ability to comply with follow-up, including in cases where the patient has a legal guardian. In such cases, consent will be provided by the legal guardian.
- Review of imaging by a radiologist and senior surgeon at a multidisciplinary tumor board, particularly evaluating hepatic hilum involvement, mesenteric root, extensive peritoneal disease in the upper abdomen, extensive hepatic or gastric involvement, and extensive intestinal involvement.
- If all the previous criteria are met and protocol acceptance is obtained, the patient will undergo a laparoscopic evaluation of all abdominal quadrants to confirm the feasibility of minimally invasive surgery (MIS). Surgery will be considered feasible if complete gross resection can be achieved with minimally invasive surgery. If minimally invasive surgery is not feasible, the patient will be excluded from the study, and the reason for unfeasibility will be described.
Who cannot join
- Evidence of a tumor not amenable to minimally invasive complete resection on preoperative imaging (CT, PET-CT, or MRI). Radiologic criteria (tumor board evaluation): hepatic hilum involvement, mesentery root, extensive peritoneal disease in upper abdomen, extensive hepatic or gastric involvement, extensive intestinal involvement
- Disease free of other active malignancies within the past 5 years, except basal cell carcinoma of the skin.
- History of psychological, familial, sociological, or geographic conditions potentially impeding adherence to the study protocol and follow-up program
- Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica
Roma, 00168
Carmine Conte, +39 0630155878, carmine.conte@policlinicogemelli.it
Carmine Conte
About this study
Official title: Minimally Invasive Interval Debulking Surgery in Advanced Ovarian Cancer, a Prospective Observational Study
In women with advanced epithelial ovarian cancer (AOC), neoadjuvant chemotherapy (NACT) combined with interval cytoreductive surgery and post-operative chemotherapy is an option.
Several retrospective studies have demonstrated the feasibility of minimally invasive surgery in case of a good response to neoadjuvant chemotherapy, and prospective randomised trial is currently underway to demonstrate the non-inferiority of minimally invasive surgery compared to laparotomy in patients with an optimal response after 3-4 cycles of neoadjuvant chemotherapy (LANCE trial, NCT04575935).
The aim of our study is to evaluate the feasibility of interval surgery after at least VI cycles of neoadjuvant chemotherapy with a minimally invasive approach.
Read the detailed description
In women with advanced epithelial ovarian cancer (AOC), neoadjuvant chemotherapy (NACT) combined with interval cytoreductive surgery (ICS) and post-operative chemotherapy is an option. Four randomised trials (EORTC55971, CHORUS, JCOG0602, SCORPION) have shown that survival rates after NACT are similar to those after primary cytoreductive surgery and adjuvant chemotherapy.
The use of neoadjuvant chemotherapy has increased significantly in recent years, and it has been shown that the determining prognostic factor is the achievement of an absent residual tumour at surgery. However, the optimal number of neoadjuvant chemotherapy cycles is not yet well defined. Several retrospective studies have evaluated the efficacy of interval debulking surgery after performing more than 4 cycles of neoadjuvant chemotherapy. In these studies, the percentage of patients undergoing >4 cycles of neoadjuvant chemotherapy varied in a range of approximately 22% to 45%. Currently, several randomised trials are ongoing, evaluating the optimal number of neoadjuvant chemotherapy cycles (3 vs. 6 cycles) in terms of complete cytoreduction (GOGER, NCT02125513) and survival (CHRONO, NCT03579394).
Several retrospective studies have demonstrated the feasibility of minimally invasive surgery in case of a good response to neoadjuvant chemotherapy (median neoadjuvant chemotherapy cycles: 4). Therefore, a prospective randomised trial is currently underway to demonstrate the non-inferiority in terms of progression-free survival of minimally invasive surgery compared to laparotomy in patients with an optimal response after 3-4 cycles of neoadjuvant chemotherapy (LANCE trial, NCT04575935).
The aim of our study is to evaluate the feasibility of interval surgery after at least VI cycles of neoadjuvant chemotherapy with a minimally invasive approach.
- Conditions
- Ovarian Cancer
- Being tested
- Minimally invasive cytoreduction
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive cytoreductionProcedure or surgery
Minimally invasive cytoreduction in patients with advanced ovarian cancer treated with 6 cycles of neoadjuvant chemotherpy
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of minimally invasive surgery
Minimally invasive surgery feasibility will be calculated on the rates of: conversion from MIS to laparotomy, complete gross resection, and protocol acceptance. In this study feasibility is defined as a conversion rate <20%, a complete gross resection rate >80% and the enrollment of at least 1 patient each month.
Measured: 15 days
Safety of minimally invasive surgery (First parameter)
2 Years Overall Survival defined as the interval time (months) between surgery and death or censored at the last follow-up
Measured: 2 years
Safety of minimally invasive surgery (Second parameter)
2 Years Disease Free Survival defined as the interval time (months) between surgery and the first occurrence of relapse or death due to ovarian cancer, whichever occurs first or censored at the last follow-up
Measured: 2 years
Safety of minimally invasive surgery (third parameter)
Safety will be evaluated using the following criteria:
- Rate of early and late severe post-operative complications (early: <30days from surgery; late: more than 30 days and less then 6 months from surgery) using Clavien Dindo classification
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmine Conte, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031908
- Sponsor's protocol ID
- 7596
- Acronym
- MISSION-2
- Status last verified
- May 2025
- First submitted
- 4 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Interval Debulking Surgery in Advanced Ovarian Cancer, a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07031908
- Acronym / sponsor ID
- MISSION-2 / 7596
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2029 (estimated)
- First posted
- 22 Jun 2025 (actual)
- 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.
In women with advanced epithelial ovarian cancer (AOC), neoadjuvant chemotherapy (NACT) combined with interval cytoreductive surgery and post-operative chemotherapy is an option.
Several retrospective studies have demonstrated the feasibility of minimally invasive surgery in case of a good response to neoadjuvant chemotherapy, and prospective randomised trial is currently underway to demonstrate the non-inferiority of minimally invasive surgery compared to laparotomy in patients with an optimal response after 3-4 cycles of neoadjuvant chemotherapy (LANCE trial, NCT04575935).
The aim of our study is to evaluate the feasibility of interval surgery after at least VI cycles of neoadjuvant chemotherapy with a minimally invasive approach.
Detailed description
In women with advanced epithelial ovarian cancer (AOC), neoadjuvant chemotherapy (NACT) combined with interval cytoreductive surgery (ICS) and post-operative chemotherapy is an option. Four randomised trials (EORTC55971, CHORUS, JCOG0602, SCORPION) have shown that survival rates after NACT are similar to those after primary cytoreductive surgery and adjuvant chemotherapy.
The use of neoadjuvant chemotherapy has increased significantly in recent years, and it has been shown that the determining prognostic factor is the achievement of an absent residual tumour at surgery. However, the optimal number of neoadjuvant chemotherapy cycles is not yet well defined. Several retrospective studies have evaluated the efficacy of interval debulking surgery after performing more than 4 cycles of neoadjuvant chemotherapy. In these studies, the percentage of patients undergoing >4 cycles of neoadjuvant chemotherapy varied in a range of approximately 22% to 45%. Currently, several randomised trials are ongoing, evaluating the optimal number of neoadjuvant chemotherapy cycles (3 vs. 6 cycles) in terms of complete cytoreduction (GOGER, NCT02125513) and survival (CHRONO, NCT03579394).
Several retrospective studies have demonstrated the feasibility of minimally invasive surgery in case of a good response to neoadjuvant chemotherapy (median neoadjuvant chemotherapy cycles: 4). Therefore, a prospective randomised trial is currently underway to demonstrate the non-inferiority in terms of progression-free survival of minimally invasive surgery compared to laparotomy in patients with an optimal response after 3-4 cycles of neoadjuvant chemotherapy (LANCE trial, NCT04575935).
The aim of our study is to evaluate the feasibility of interval surgery after at least VI cycles of neoadjuvant chemotherapy with a minimally invasive approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with primary advanced epithelial ovarian cancer, FIGO stage III-IV not candidate for primary debulking surgery at diagnosis or after III-IV cycles of neoadjuvant chemotherapy.
Key inclusion criteria (7 listed)
- Stage IIIC or IV high-grade invasive epithelial ovarian carcinoma (serous, endometrioid, clear cell, transitional), primary peritoneal carcinoma, or fallopian tube carcinoma, or pathology consistent with high-grade Müllerian carcinoma.
- Partial or complete radiological response of abdominal cavity disease after at least 6 cycles of neoadjuvant chemotherapy (NACT).
- CA125 < 100 U/mL.
- ECOG performance status 0-1.
- Signed informed consent and ability to comply with follow-up, including in cases where the patient has a legal guardian. In such cases, consent will be provided by the legal guardian.
Key exclusion criteria (4 listed)
- Evidence of a tumor not amenable to minimally invasive complete resection on preoperative imaging (CT, PET-CT, or MRI). Radiologic criteria (tumor board evaluation): hepatic hilum involvement, mesentery root, extensive peritoneal disease in upper abdomen, extensive hepatic or gastric involvement, extensive intestinal involvement
- Disease free of other active malignancies within the past 5 years, except basal cell carcinoma of the skin.
- History of psychological, familial, sociological, or geographic conditions potentially impeding adherence to the study protocol and follow-up program
- Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum
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 |
|---|---|---|
| Minimally invasive cytoreductionMinimally invasive cytoreduction in patients with advanced ovarian cancer treated with 6 cycles of neoadjuvant chemotherpy | Procedure or surgery | – |
Primary outcome
Feasibility of minimally invasive surgery
Time frame: 15 days
Minimally invasive surgery feasibility will be calculated on the rates of: conversion from MIS to laparotomy, complete gross resection, and protocol acceptance. In this study feasibility is defined as a conversion rate <20%, a complete gross resection rate >80% and the enrollment of at least 1 patient each month.
Safety of minimally invasive surgery (First parameter)
Time frame: 2 years
2 Years Overall Survival defined as the interval time (months) between surgery and death or censored at the last follow-up
Safety of minimally invasive surgery (Second parameter)
Time frame: 2 years
2 Years Disease Free Survival defined as the interval time (months) between surgery and the first occurrence of relapse or death due to ovarian cancer, whichever occurs first or censored at the last follow-up
Safety of minimally invasive surgery (third parameter)
Time frame: 6 months
Safety will be evaluated using the following criteria: - Rate of early and late severe post-operative complications (early: <30days from surgery; late: more than 30 days and less then 6 months from surgery) using Clavien Dindo classification
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 22 Jun 2025.
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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.
Carmine Conte principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Contact Carmine Conte (+39 063015 5878, carmine.conte@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of minimally invasive surgery (time frame: 15 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2025.