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Advanced Ovarian CarcinomaPhase 3NCT04575935

Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial

A Phase 3 study testing Chemotherapy, Laparotomy and Minimally Invasive Surgery in people with Advanced Ovarian Carcinoma and Fallopian Tube Clear Cell Adenocarcinoma, run by M.D. Anderson Cancer Center at 19 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase III trial compares minimally invasive surgery (MIS) to laparotomy in treating patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy before and after surgery (neoadjuvant chemotherapy). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Chemotherapy, Laparotomy and Minimally Invasive Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
580 participants
Where
19 sitesin 5 countries
Study dates
5 Aug 2020to 31 Dec 2028
Phase
Phase 3
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

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

19 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Jose A. Rauh-Hain, MD, MPH contact

713-794-1759

jarauh@mdanderson.org

19 sites in 5 countries

United States13 sites, 12 recruiting

  • St. Luke's University Health Network

    Bethlehem, Pennsylvania, 18015

    Nicholas Taylor, MD, nicholas.taylor@sluhn.org

    Nicholas Taylor, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Alexander Melamed, MD, alexander.melamed@mgh.harvard.edu

    Alexander Melamed

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Neil Horowitz, MD, 877-338-7425, nhorowitz@partners.org

    Neil Horowitz, (877) 338-7425, nhorowitz@mgh.harvard.edu

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Chad Michener, MD, michenc@ccf.org

    Chad Michener

    Recruiting

  • Duke

    Durham, North Carolina, 27710

    Leah McNally, MD, 919-780-7070, Leah.McNally018@duke.edu

    Leah McNally, MD

    Recruiting

  • Lyndon Baines Johnson General

    Houston, Texas, 77026

    Jose Rauh-Hain, MD, 713-794-1759, jarauh@mdanderson.org

    Jose Rauh-Hain, MD

    Recruiting

  • Houston Methodist

    Houston, Texas, 77030

    Pedro Ramirez, MD, pramirez3@houstonmethodist.org

    Pedro Ramirez

    Recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Jose A. Rauh-Hain, MD,MPH, 713-794-1759, jarauh@mdanderson.org

    Jose A. Rauh-Hain

    Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

    Active, not recruiting

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

    Abdulrahman Sinno, MD, ak.sinno@med.miami.edu

    Abdulrahman Sinno, MD

    Recruiting

  • NYU Langone Health

    Mineola, New York, 11501

    Edward Jimenez, MD, edward.jimenez@nyulangone.org

    Edward Jimenez, MD

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Jason D. Wright, MD, jw2459@cumc.columbia.edu

    Jason D. Wright, MD

    Recruiting

  • Cleveland Clinic Foundation - Florida

    Weston, Florida, 33331

    Joel Cardenas, MD, cardenj3@ccf.org

    Joel Cardenas

    Recruiting

Other trials in United States

Canada2 sites, 2 recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre - Calgary

    Calgary

    Gregg Nelson, MD, gregg.nelson@albertahealthservices.ca

    Gregg Nelson

    Recruiting

  • University Health Network - Princess Margaret Cancer Centre

    Toronto

    Liat Hogen, MD, liat.hogen@uhn.ca

    Liat Hogen

    Recruiting

Other trials in Canada

Italy2 sites, 2 recruiting

  • Sant'Orsola Hospital di Bologna

    Bologna, 40138

    Pierandrea De laco, MD, pierandrea.deiaco@unibo.it

    Pierandrea De laco

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168

    Anna Fagotti, MD, anna.fagotti@unicatt.it

    Anna Fagotti

    Recruiting

Other trials in Italy

Mexico1 site, 1 recruiting

  • Instituto Nacional de Cancerología (Mexico)

    Tlalpan

    David Ortiz, MD, islasurgery@hotmail.com

    David Isla Ortiz

    Recruiting

Other trials in Mexico

Netherlands1 site, 1 recruiting

  • Amsterdam UMC - Locatie AMC | H5Zuid 154

    Amsterdam

    Luc van Lonkhuijzen, MD

    Luc van Lonkhuijzen

    Recruiting

Other trials in Netherlands

About this study

Official title: Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy

This phase III trial compares minimally invasive surgery (MIS) to laparotomy in treating patients with stage IIIC-IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy before and after surgery (neoadjuvant chemotherapy). MIS is a surgical procedure that uses small incision(s) and is intended to produce minimal blood loss and pain for the patient. Laparotomy is a surgical procedure which allows the doctors to remove some or all of the tumor and check if the disease has spread to other organs in the body. MIS may work the same or better than standard laparotomy after chemotherapy in prolonging the return of the disease and/or improving quality of life after surgery.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To examine whether MIS is non-inferior to laparotomy in terms of disease free survival (DFS) in women with advanced stage epithelial ovarian cancer (EOC) that received 3 to 4 cycles of neoadjuvant chemotherapy (NACT).

SECONDARY OBJECTIVES:

  1. To determine if there are differences in health-related quality of life (HR-QoL) in patients undergoing MIS versus (vs) laparotomy as assessed with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30), QLQ-Ovarian Cancer Module (OV28), and Functional Assessment of Cancer Therapy-General (FACT-G7).

II. To determine if there are differences between patients undergoing MIS vs laparotomy in the rate of optimal cytoreduction (defined as residual tumor nodules each measuring 1 cm or less in maximum diameter) and complete cytoreduction (defined as no evidence of macroscopic disease).

III. To examine whether MIS is non-inferior to laparotomy in terms of overall survival (OS) in women with advanced stage EOC that received 3 to 4 cycles of NACT.

IV. To determine if there are differences between patients undergoing MIS vs laparotomy in surgical morbidity and mortality, intraoperative injuries, and post-operative complications.

  1. To determine the rates of MIS converted to laparotomy and the reasons.

VI. To determine if there are any difference in costs and cost-effectiveness between patients undergoing MIS vs laparotomy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo MIS within 6 weeks after last cycle of standard of care neoadjuvant chemotherapy. If during MIS the surgeon thinks complete gross resection can only be accomplished by performing an open procedure, patients may undergo laparotomy instead. Within 6 weeks after surgery, patients receive standard of care chemotherapy.

ARM B: Patients undergo laparotomy within 6 weeks after last cycle of standard of care neoadjuvant chemotherapy. Within 6 weeks after surgery, patients receive standard of care chemotherapy.

After completion of study, patients are followed up within 6 weeks of completing post-surgery chemotherapy, then every 3 months for the first 2 years, and then every 6 months for 3 years.

Being tested
Chemotherapy, Laparotomy, Minimally Invasive Surgery, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChemotherapyDrug

    Also called Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

    Receive standard of care chemotherapy

  • LaparotomyProcedure or surgery

    Undergo laparotomy

  • Minimally Invasive SurgeryProcedure or surgery

    Also called Minimally-Invasive Surgery

    Undergo MIS

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04575935
Study groupRoleWhat they receive
Arm A (MIS, standard of care chemotherapy)ExperimentalPatients undergo MIS within 6 weeks after last cycle of standard of care neoadjuvant chemotherapy. If during MIS the surgeon thinks complete gross resection can only be accomplished by performing an open procedure, patients may undergo laparotomy instead. Within 6 weeks after surgery, patients receive standard of care chemotherapy.
Receives: Drug: Chemotherapy; Procedure: Minimally Invasive Surgery; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm B (laparotomy, standard of care chemotherapy)Active comparatorPatients undergo laparotomy within 6 weeks after last cycle of standard of care neoadjuvant chemotherapy. Within 6 weeks after surgery, patients receive standard of care chemotherapy.
Receives: Drug: Chemotherapy; Procedure: Laparotomy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease free survival (DFS)

    Kaplan Meier curves will be used to describe DFS over time. Log-rank test will be used to compare DFS between the control and experimental arms. The treatment effects will be summarized by means of a hazard ratio with its associated 95% confidence interval. Two years DFS rate will be computed with a targeted 95% confidence interval (CI).

    Measured: Between randomization and physical or radiographic evidence of recurrence (local/distant) or death (all causes), assessed up to 5 years

Secondary outcomes (12)

  1. Health related-quality of life (HR-QoL)

    HR-QoL of patients will be assessed with European Organization for Research and Treatment of Cancer (EORTC Scale 1-Not at all, 2-A little bit, 3-Quite a bit, 4-Very Much)

    Measured: Up to 1 year post surgery chemotherapy

  2. Health related-quality of life (HR-QoL)

    HR-QoL of patients will be assessed Quality of Life Questionnaire-Core 30 (QLQC30 scale 1-Not at all, 2-A little bit, 3-Quite a bit, 4-Very Much)

    Measured: Up to 1 year post surgery chemotherapy

  3. Health related-quality of life (HR-QoL)

    HR-QoL of patients will be assessed with QLQ-Ovarian Cancer Module (OV28 Scale 1- Not at all, 2- A little bit, 3-Quite a bit, 4-Very Much).) (ovarian supplement)

    Measured: Up to 1 year post surgery chemotherapy

  4. Health related-quality of life (HR-QoL)

    HR-QoL of patients will be assessed with Functional Assessment of Cancer Therapy-General short-form (FACT-G7 Scale 1- Not at all, 2- A little bit, 3-Quite a bit, 4-Very Much).

    Measured: Up to 1 year post surgery chemotherapy

  5. Optimal cytoreduction

    Defined as residual tumor nodules each measuring 1 cm or less in maximum diameter.

    Measured: At the end of surgery

  6. Complete cytoreduction

    Defined as no evidence of macroscopic disease.

    Measured: At the end of surgery

  7. Overall survival (OS)

    Overall survival will be estimated using the Kaplan-Meier method, and will be described using the median with its 95% CI. Univariate Cox proportional hazards model (i.e., logrank test) will be used to estimate hazard ratios (HR: control arm versus investigational arm) with a 95% CI. When appropriate, multivariate Cox analyses will be performed, in which a univariate selection procedure will serve to identify eligible explanatory variables with univariate Cox (using Wald test) p-value lower than 0.10 as potential prognostic value. Follow-up will be estimated using the reverse Kaplan-Meier method, and will be described using the median with its 95% CI.

    Measured: Between randomization and death (all causes), assessed up to 5 years

  8. Surgical morbidity

    Rates of surgical complications according to Surgical morbidity (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0 \& Clavien Dindo classification and mortality (30-day post-operative for adverse events and up to 6 months post-operative for adverse events of interest).

    Measured: Up to 6 months post surgery

  9. Mortality

    Mortality rates (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0 \& Clavien Dindo classification and mortality (30-day post-operative for adverse events and up to 6 months post-operative for adverse events of interest).

    Measured: Up to 6 months post surgery

  10. Intraoperative injuries

    Coded as yes or no and categorized as involving the bowel, veins, arteries, ureter, bladder, or other site.

    Measured: During surgery

  11. Minimally invasive surgery (MIS) converted to laparotomy

    Prospectively completed forms documented reasons for conversion of MIS to laparotomy.

    Measured: During surgery

  12. Cost of the procedure

    A cost analysis may be performed in some countries.

    Measured: Up to 6 months post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2020
  2. Study start5 Aug 2020
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
580 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04575935
Sponsor's protocol ID
2020-0165
Other IDs
NCI-2020-04165, 2020-0165
Status last verified
Sep 2026
First submitted
8 Sep 2020
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Rauh-Hain JA, Melamed A, Pareja R, May T, Sinno A, McNally L, Horowitz NS, De Iaco P, Michener CM, Van Lonkhuijzen L, Iniesta MD, Yuan Y, Ramirez PT, Fagotti A. Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy in High-Grade Epithelial Ovarian Cancer: A LANCE Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2446325. doi: 10.1001/jamanetworkopen.2024.46325.

    PubMed 39570589

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Chemotherapy, Laparotomy and Minimally Invasive Surgery in people with Advanced Ovarian Carcinoma and Fallopian Tube Clear Cell Adenocarcinoma, run by M.D. Anderson Cancer Center at 19 sites in 5 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 9 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada, Italy, Mexico, Netherlands. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Jose A. Rauh-Hain, MD, MPH (713-794-1759, jarauh@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease free survival (DFS) (time frame: Between randomization and physical or radiographic evidence of recurrence (local/distant) or death (all causes), assessed up to 5 years). 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 NCT04575935, which also lists 1 linked publication.

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 14 Sep 2026.

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