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Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
NCT04575935 · M.D. Anderson Cancer Center
In plain English
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Official title
Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy
About this study
PRIMARY OBJECTIVE:
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.
Eligibility criteria
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 target: 580 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2020-08-05
Estimated completion: 2028-12-31
Last updated: 2026-03-05
Interventions
Drug: ChemotherapyProcedure: LaparotomyProcedure: Minimally Invasive SurgeryOther: Quality-of-Life AssessmentOther: Questionnaire Administration
Primary outcomes
- • Disease free survival (DFS) (Between randomization and physical or radiographic evidence of recurrence (local/distant) or death (all causes), assessed up to 5 years)
Sponsor
M.D. Anderson Cancer Center · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactJose A. Rauh-Hain, MD, MPH · contact · jarauh@mdanderson.org · 713-794-1759
InvestigatorJose A Rauh-Hain · principal_investigator, M.D. Anderson Cancer Center
All locations (19)
University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
Miami, Florida, United States
Cleveland Clinic Foundation - FloridaRecruiting
Weston, Florida, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
NYU Langone HealthRecruiting
Mineola, New York, United States
Columbia University Medical CenterRecruiting
New York, New York, United States
DukeRecruiting
Durham, North Carolina, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
St. Luke's University Health NetworkRecruiting
Bethlehem, Pennsylvania, United States
Lyndon Baines Johnson GeneralRecruiting
Houston, Texas, United States
Houston MethodistRecruiting
Houston, Texas, United States
M D Anderson Cancer CenterRecruiting
Houston, Texas, United States
University of Wisconsin Carbone Cancer CenterActive Not Recruiting
Madison, Wisconsin, United States
Arthur J.E. Child Comprehensive Cancer Centre - CalgaryRecruiting
Calgary, Canada
University Health Network - Princess Margaret Cancer CentreRecruiting
Toronto, Canada
Sant'Orsola Hospital di BolognaRecruiting
Bologna, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Rome, Italy
Instituto Nacional de Cancerología (Mexico)Recruiting
Tlalpan, Mexico
Amsterdam UMC - Locatie AMC | H5Zuid 154Recruiting
Amsterdam, Netherlands