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Minimally invasive surgery for advanced ovarian cancer after chemotherapy

Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy

Phase 3 Interventional M.D. Anderson Cancer Center · NCT04575935

This study is testing if a less invasive surgery is just as effective as traditional surgery for women with advanced ovarian cancer after they have had chemotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment580 (estimated)
Ages18 Years and up
SexFemale
SponsorM.D. Anderson Cancer Center Academic / other
Drugs / interventionschemotherapy
Locations19 sites (Miami, Florida and 18 other locations)
Trial IDNCT04575935 on ClinicalTrials.gov

What this trial studies

This phase III trial compares minimally invasive surgery (MIS) to traditional laparotomy in treating women with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who have undergone neoadjuvant chemotherapy. The study aims to determine if MIS is as effective as laparotomy in terms of disease-free survival and overall survival, while also assessing differences in quality of life, surgical outcomes, and costs. Patients will be randomized to receive either surgical approach after completing chemotherapy, with various health-related quality of life assessments conducted throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older with advanced stage high-grade epithelial ovarian cancer who have completed neoadjuvant chemotherapy.

Not a fit: Patients with lower stage ovarian cancer or those not considered surgical candidates after chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to less invasive surgical options for patients, potentially improving recovery times and quality of life.

How similar studies have performed: Other studies have shown promising results with minimally invasive approaches in various cancers, suggesting potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Miami, Florida and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Advanced Ovarian CarcinomaFallopian Tube Clear Cell AdenocarcinomaFallopian Tube Endometrioid TumorFallopian Tube Serous NeoplasmFallopian Tube Transitional Cell CarcinomaOvarian Clear Cell AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Serous Adenocarcinoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.