Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
NCT ID: NCT04575935
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
580 participants
INTERVENTIONAL
2020-08-05
2028-12-31
Brief Summary
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Detailed Description
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I. 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:
I. 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.
V. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Chemotherapy
Receive standard of care chemotherapy
Minimally Invasive Surgery
Undergo MIS
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
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.
Chemotherapy
Receive standard of care chemotherapy
Laparotomy
Undergo laparotomy
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Chemotherapy
Receive standard of care chemotherapy
Laparotomy
Undergo laparotomy
Minimally Invasive Surgery
Undergo MIS
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jose A Rauh-Hain
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Luc van Lonkhuijzen, MD
Role: primary
References
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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.
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2020-04165
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-0165
Identifier Type: OTHER
Identifier Source: secondary_id
2020-0165
Identifier Type: -
Identifier Source: org_study_id
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