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RecruitingPhase 3NCT04575935

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

Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy

Sponsor

M.D. Anderson Cancer Center

Enrollment

580 participants

Start Date

Aug 5, 2020

Study Type

INTERVENTIONAL

Conditions

Stage IV Ovarian Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Advanced Ovarian CarcinomaStage IV Fallopian Tube Cancer AJCC v8Stage IIIC Fallopian Tube Cancer AJCC v8Stage IIIC Primary Peritoneal Cancer AJCC v8Stage IV Primary Peritoneal Cancer AJCC v8Stage IVA Fallopian Tube Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Primary Peritoneal Cancer AJCC v8Stage IVB Fallopian Tube Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8Stage IVB Primary Peritoneal Cancer AJCC v8Fallopian Tube Clear Cell AdenocarcinomaOvarian Clear Cell AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Serous AdenocarcinomaPrimary Peritoneal Clear Cell AdenocarcinomaPrimary Peritoneal Endometrioid AdenocarcinomaPrimary Peritoneal Serous AdenocarcinomaFallopian Tube Endometrioid TumorFallopian Tube Serous NeoplasmFallopian Tube Transitional Cell CarcinomaOvarian Transitional Cell CarcinomaPrimary Peritoneal Transitional Cell Carcinoma

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares minimally invasive surgery (laparoscopy or robotic) versus open surgery for women with advanced ovarian, fallopian tube, or peritoneal cancer who have already received 3–4 rounds of chemotherapy before surgery. The goal is to determine whether minimally invasive surgery is just as effective while reducing recovery time. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with stage IIIC or IV high-grade ovarian, peritoneal, or fallopian tube cancer - You have completed 3–4 cycles of platinum-based chemotherapy - Imaging shows the cancer responded well to chemotherapy - Your CA-125 tumor marker has normalized, or surgery is planned following a diagnostic laparoscopy - You are in good enough health to undergo surgery (ECOG 0–2) **You may NOT be eligible if...** - Imaging suggests the cancer cannot be safely removed with minimally invasive surgery - You have ascites (fluid buildup) that did not improve with chemotherapy - There is cancer involving the small intestine, stomach, colon, or rectum - You are pregnant - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChemotherapy

Receive standard of care chemotherapy

PROCEDURELaparotomy

Undergo laparotomy

PROCEDUREMinimally Invasive Surgery

Undergo MIS

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

Locations(19)

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Cleveland Clinic Foundation - Florida

Weston, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

NYU Langone Health

Mineola, New York, United States

Columbia University Medical Center

New York, New York, United States

Duke

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Lyndon Baines Johnson General

Houston, Texas, United States

Houston Methodist

Houston, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Arthur J.E. Child Comprehensive Cancer Centre - Calgary

Calgary, Canada

University Health Network - Princess Margaret Cancer Centre

Toronto, Canada

Sant'Orsola Hospital di Bologna

Bologna, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Instituto Nacional de Cancerología (Mexico)

Tlalpan, Mexico

Amsterdam UMC - Locatie AMC | H5Zuid 154

Amsterdam, Netherlands

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NCT04575935

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