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

Part of paid clinical trials in Miami, Florida.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT04575935
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Ovarian Carcinoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Fallopian Tube Endometrioid Tumor
  • Fallopian Tube Serous Neoplasm
  • Fallopian Tube Transitional Cell Carcinoma
  • Ovarian Clear Cell Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Serous Adenocarcinoma
  • Ovarian Transitional Cell Carcinoma
  • Primary Peritoneal Clear Cell Adenocarcinoma
  • Primary Peritoneal Endometrioid Adenocarcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Primary Peritoneal Transitional Cell Carcinoma
  • Stage IIIC Fallopian Tube Cancer AJCC v8
  • Stage IIIC Ovarian Cancer AJCC v8
  • Stage IIIC Primary Peritoneal Cancer AJCC v8
  • Stage IV Fallopian Tube Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IV Primary Peritoneal Cancer AJCC v8
  • Stage IVA Fallopian Tube Cancer AJCC v8
  • Stage IVA Ovarian Cancer AJCC v8
  • Stage IVA Primary Peritoneal Cancer AJCC v8
  • Stage IVB Fallopian Tube Cancer AJCC v8
  • Stage IVB Ovarian Cancer AJCC v8
  • Stage IVB Primary Peritoneal Cancer AJCC v8

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy — DRUG
    Receive standard of care chemotherapy
  • Laparotomy — PROCEDURE
    Undergo laparotomy
  • Minimally Invasive Surgery — PROCEDURE
    Undergo MIS
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Aug 5, 2020
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
580 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (13)

FacilityCityStateZIPSite coordinators
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiamiFlorida33136
Abdulrahman Sinno, MD
[email protected]
Abdulrahman Sinno, MD (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic Foundation - FloridaWestonFlorida33331
Joel Cardenas, MD
[email protected]
Joel Cardenas (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Neil Horowitz, MD
[email protected]
877-338-7425
Neil Horowitz
[email protected]
(877) 338-7425
Massachusetts General HospitalBostonMassachusetts02114
Alexander Melamed, MD
[email protected]
Alexander Melamed (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthMineolaNew York11501
Edward Jimenez, MD
[email protected]
Edward Jimenez, MD (PRINCIPAL_INVESTIGATOR)
Columbia University Medical CenterNew YorkNew York10032
Jason D. Wright, MD
[email protected]
Jason D. Wright, MD (PRINCIPAL_INVESTIGATOR)
DukeDurhamNorth Carolina27710
Leah McNally, MD
[email protected]
919-780-7070
Leah McNally, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Chad Michener, MD
[email protected]
Chad Michener (PRINCIPAL_INVESTIGATOR)
St. Luke's University Health NetworkBethlehemPennsylvania18015
Nicholas Taylor, MD
[email protected]
Nicholas Taylor, MD (PRINCIPAL_INVESTIGATOR)
Houston MethodistHoustonTexas77030
Pedro Ramirez, MD
[email protected]
Pedro Ramirez (PRINCIPAL_INVESTIGATOR)
Lyndon Baines Johnson GeneralHoustonTexas77026
Jose Rauh-Hain, MD
[email protected]
713-794-1759
Jose Rauh-Hain, MD (PRINCIPAL_INVESTIGATOR)
M D Anderson Cancer CenterHoustonTexas77030
Jose A. Rauh-Hain, MD,MPH
[email protected]
713-794-1759
Jose A. Rauh-Hain (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792-

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University of Miami Miller School of Medicine-Sylvester Cancer Center· Miami, FLCleveland Clinic Foundation - Florida· Weston, FLDana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MANYU Langone Health· Mineola, NYColumbia University Medical Center· New York, NY

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