Less invasive surgery may improve recovery for ovarian cancer patients
NCT ID NCT04575935
First seen Jun 25, 2026 · Last updated Sep 15, 2026 · Updated 3 times
Summary
This study compares two surgical approaches for people with advanced ovarian, fallopian tube, or primary peritoneal cancer who have received chemotherapy before surgery. One group will have minimally invasive surgery (small incisions), and the other will have standard open surgery (larger incision). The goal is to see if the less invasive method works as well or better at delaying cancer return and improving quality of life. About 580 participants will be enrolled.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Minimally invasive surgery (laparoscopy)
- What this could lead to
- If successful, this could show that a less invasive surgery works as well as open surgery, helping patients recover faster with less pain and a better quality of life after treatment.
- What could go wrong
- This is a large Phase 3 trial, but it is still possible that minimally invasive surgery may not control the cancer as effectively as open surgery, or that benefits are small. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 580 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2020
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years old * Stage IIIC or IV, high-grade (serous, endometrioid, clear-cell, transitional carcinomas), invasive epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian-tube carcinoma or pathology consistent with high-grade mullerian carcinoma. * Patient is considered by treating physician to be a surgical candidate after completion of 3 to 4 cycles of platinum-based chemotherapy, or an investigational neoadjuvant regimen given according to protocol, with complete radiologic resolution of any disease outside the abdominal cavity. Pleural effusions are acceptable per the local PI's discretion. * Normalization of CA-125 according to individual participating center reference range (Note: Among patients with a normal CA-125 at initiation of therapy, the CA-125 cannot exceed 35 U/mL at the completion of NACT prior to interval debulking surgery.) or has a CA-125 value ≤500 and is scheduled to undergo a diagnostic laparoscopy prior to debulking surgery. a. For patients undergoing diagnostic laparoscopy, surgeon considers that optimal debulking is feasible either by MIS or laparotomy. * Timeframe of \< 6 weeks (42 days) from the last cycle of NACT to interval debulking surgery. Overall timeframe may be extended per MD Anderson PI discretion. * ECOG performance status 0-2 * Signed informed consent and ability to comply with follow-up * Negative pregnancy test by blood or urine (within 14 days prior to surgery) * Disease free of other active malignancies in the previous five years, except basal and squamous cell carcinomas of the skin Exclusion Criteria: * Evidence of tumor not amenable to minimally invasive resection on pre-operative imaging (CT, PET-CT, or MRI) including but not limited to the following findings that may preclude minimally invasive resection per surgeon's assessment. • Failure of improvement of ascites during NACT (trace ascites is allowed) • Small bowel or gastric tumor involvement • Colon or rectal tumor involvement • Diaphragmatic tumor involvement • Splenic or hepatic surface or parenchymal tumor involvement • Mesenteric tumor involvement • Tumor infiltration of the lesser peritoneal sac * History of psychological, familial, sociological or geographical condition potentially preventing compliance with the study protocol and follow-up schedule * Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum as deemed by participating institution's clinicians * Any other contraindication to MIS as assessed by the clinician
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
18 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Amsterdam UMC - Locatie AMC | H5Zuid 154
RECRUITINGAmsterdam, Netherlands
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Arthur J.E. Child Comprehensive Cancer Centre - Calgary
RECRUITINGCalgary, Canada
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Cleveland Clinic
RECRUITINGCleveland, Ohio, 44195, United States
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Cleveland Clinic Foundation - Florida
RECRUITINGWeston, Florida, 33331, United States
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Columbia University Medical Center
RECRUITINGNew York, New York, 10032, United States
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Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
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Duke
RECRUITINGDurham, North Carolina, 27710, United States
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITINGRome, 00168, Italy
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Houston Methodist
RECRUITINGHouston, Texas, 77030, United States
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Instituto Nacional de Cancerología (Mexico)
RECRUITINGTlalpan, Mexico
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Lyndon Baines Johnson General
RECRUITINGHouston, Texas, 77026, United States
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M D Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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NYU Langone Health
RECRUITINGMineola, New York, 11501, United States
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Sant'Orsola Hospital di Bologna
RECRUITINGBologna, 40138, Italy
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St. Luke's University Health Network
RECRUITINGBethlehem, Pennsylvania, 18015, United States
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University Health Network - Princess Margaret Cancer Centre
RECRUITINGToronto, Canada
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University of Miami Miller School of Medicine-Sylvester Cancer Center
RECRUITINGMiami, Florida, 33136, United States
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University of Wisconsin Carbone Cancer Center
ACTIVE_NOT_RECRUITINGMadison, Wisconsin, 53792, United States
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- New drug combo aims to improve ovarian cancer maintenance with fewer dropouts