Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT04575935

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

Led by M.D. Anderson Cancer Center · Updated on 2026-03-05

580

Participants Needed

19

Research Sites

438 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Stage IIIC or IV high-grade (serous, endometrioid, clear-cell, transitional) invasive epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma or high-grade mullerian carcinoma
  • Considered a surgical candidate after 3 to 4 cycles of platinum-based or investigational neoadjuvant chemotherapy with complete radiologic resolution outside the abdomen
  • Normalized CA-125 or CA-125 ≤ 500 U/mL with planned diagnostic laparoscopy
  • Interval debulking surgery planned within 6 weeks after last chemotherapy cycle
  • ECOG performance status 0 to 2
  • Signed informed consent and ability to comply with follow-up
  • Negative pregnancy test within 14 days prior to surgery
  • No active other malignancies in past 5 years except certain skin cancers
Not Eligible

You will not qualify if you...

  • Tumor not suitable for minimally invasive surgery based on pre-operative imaging including unresolved ascites, involvement of small bowel, stomach, colon, rectum, diaphragm, spleen, liver, mesentery, or lesser peritoneal sac
  • Psychological, familial, sociological, or geographical conditions preventing compliance
  • Unable to tolerate prolonged Trendelenburg position or pneumoperitoneum
  • Any other clinician-assessed contraindication to minimally invasive surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 19 locations

1

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States, 33136

Actively Recruiting

2

Cleveland Clinic Foundation - Florida

Weston, Florida, United States, 33331

Actively Recruiting

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

4

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

5

NYU Langone Health

Mineola, New York, United States, 11501

Actively Recruiting

6

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

7

Duke

Durham, North Carolina, United States, 27710

Actively Recruiting

8

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

9

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States, 18015

Actively Recruiting

10

Lyndon Baines Johnson General

Houston, Texas, United States, 77026

Actively Recruiting

11

Houston Methodist

Houston, Texas, United States, 77030

Actively Recruiting

12

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

13

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States, 53792

Active, Not Recruiting

14

Arthur J.E. Child Comprehensive Cancer Centre - Calgary

Calgary, Canada

Actively Recruiting

15

University Health Network - Princess Margaret Cancer Centre

Toronto, Canada

Actively Recruiting

16

Sant'Orsola Hospital di Bologna

Bologna, Italy, 40138

Actively Recruiting

17

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy, 00168

Actively Recruiting

18

Instituto Nacional de Cancerología (Mexico)

Tlalpan, Mexico

Actively Recruiting

19

Amsterdam UMC - Locatie AMC | H5Zuid 154

Amsterdam, Netherlands

Actively Recruiting

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Research Team

J

Jose A. Rauh-Hain, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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