Recruiting

Phase 3

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

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04575935

Conditions

Advanced Ovarian Carcinoma

Fallopian Tube Clear Cell Adenocarcinoma

Fallopian Tube Endometrioid Tumor

Fallopian Tube Serous Neoplasm

Fallopian Tube Transitional Cell Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Chemotherapy

Laparotomy

Minimally Invasive Surgery

Quality-of-Life Assessment

Questionnaire Administration

Study Details

Brief 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). 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.

Conditions

Advanced Ovarian Carcinoma

Fallopian Tube Clear Cell Adenocarcinoma

Fallopian Tube Endometrioid Tumor

Fallopian Tube Serous Neoplasm

Fallopian Tube Transitional Cell Carcinoma

Study ID

NCT04575935

Start date

Aug 5, 2020

Status verified date

Mar, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

580 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A (MIS, standard of care chemotherapy)

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.

active comparator: Arm B (laparotomy, standard of care chemotherapy)

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.

Interventions

Chemotherapy

Receive standard of care chemotherapy

Laparotomy

Undergo laparotomy

Minimally Invasive Surgery

Undergo MIS

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

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 ]

Central Contacts and Locations

Central contacts

Jose A. Rauh-Hain, MD, MPH

713-794-1759 jarauh@mdanderson.org

Locations

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Abdulrahman Sinno, MD

ak.sinno@med.miami.edu

Principal Investigator:

Abdulrahman Sinno, MD

Cleveland Clinic Foundation - Florida

Recruiting

Weston, Florida, United States, 33331

Contacts

Joel Cardenas, MD

cardenj3@ccf.org

Principal Investigator:

Joel Cardenas

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Alexander Melamed, MD

alexander.melamed@mgh.harvard.edu

Principal Investigator:

Alexander Melamed

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Neil Horowitz, MD

877-338-7425 nhorowitz@partners.org

Neil Horowitz

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

NYU Langone Health

Recruiting

Mineola, New York, United States, 11501

Contacts

Edward Jimenez, MD

edward.jimenez@nyulangone.org

Principal Investigator:

Edward Jimenez, MD

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Jason D. Wright, MD

jw2459@cumc.columbia.edu

Principal Investigator:

Jason D. Wright, MD

Duke

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Leah McNally, MD

919-780-7070 Leah.McNally018@duke.edu

Principal Investigator:

Leah McNally, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Chad Michener, MD

michenc@ccf.org

Principal Investigator:

Chad Michener

St. Luke's University Health Network

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Contacts

Nicholas Taylor, MD

nicholas.taylor@sluhn.org

Principal Investigator:

Nicholas Taylor, MD

Lyndon Baines Johnson General

Recruiting

Houston, Texas, United States, 77026

Contacts

Jose Rauh-Hain, MD

713-794-1759 jarauh@mdanderson.org

Principal Investigator:

Jose Rauh-Hain, MD

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

Pedro Ramirez, MD

pramirez3@houstonmethodist.org

Principal Investigator:

Pedro Ramirez

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Jose A. Rauh-Hain, MD,MPH

713-794-1759 jarauh@mdanderson.org

Principal Investigator:

Jose A. Rauh-Hain

Arthur J.E. Child Comprehensive Cancer Centre - Calgary

Recruiting

Calgary, Canada

Contacts

Gregg Nelson, MD

gregg.nelson@albertahealthservices.ca

Principal Investigator:

Gregg Nelson

University Health Network - Princess Margaret Cancer Centre

Recruiting

Toronto, Canada

Contacts

Liat Hogen, MD

liat.hogen@uhn.ca

Principal Investigator:

Liat Hogen

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-03-05.