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Clinical Trials in Canada / NCT04575935
Recruiting Phase 3

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

NCT04575935 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2020-08-05
Last updated
2026-09-14

Condition(s) studied

Advanced Ovarian CarcinomaFallopian Tube Clear Cell AdenocarcinomaFallopian Tube Endometrioid TumorFallopian Tube Serous NeoplasmFallopian Tube Transitional Cell CarcinomaOvarian Clear Cell AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Serous AdenocarcinomaOvarian Transitional Cell CarcinomaPrimary Peritoneal Clear Cell AdenocarcinomaPrimary Peritoneal Endometrioid AdenocarcinomaPrimary Peritoneal Serous AdenocarcinomaPrimary Peritoneal Transitional Cell CarcinomaStage IIIC Fallopian Tube Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage IIIC Primary Peritoneal Cancer AJCC v8Stage IV Fallopian Tube Cancer AJCC v8Stage IV Ovarian 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 v8

Investigational drug(s) / intervention(s)

ChemotherapyLaparotomyMinimally Invasive SurgeryQuality-of-Life AssessmentQuestionnaire Administration

Chemotherapy: Receive standard of care chemotherapy

Laparotomy: Undergo laparotomy

Minimally Invasive Surgery: Undergo MIS

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Study 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
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida Recruiting
Cleveland Clinic Foundation - Florida Weston Florida Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
NYU Langone Health Mineola New York Recruiting
Columbia University Medical Center New York New York Recruiting
Duke Durham North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
St. Luke's University Health Network Bethlehem Pennsylvania Recruiting
Lyndon Baines Johnson General Houston Texas Recruiting
Houston Methodist Houston Texas Recruiting
M D Anderson Cancer Center Houston Texas Recruiting
University of Wisconsin Carbone Cancer Center Madison Wisconsin Active Not Recruiting
Arthur J.E. Child Comprehensive Cancer Centre - Calgary Calgary Canada Recruiting
University Health Network - Princess Margaret Cancer Centre Toronto Canada Recruiting
Sant'Orsola Hospital di Bologna Bologna Italy Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy Recruiting
Instituto Nacional de Cancerología (Mexico) Tlalpan Mexico Recruiting
Amsterdam UMC - Locatie AMC | H5Zuid 154 Amsterdam Netherlands Recruiting

More M.D. Anderson Cancer Center trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04575935 on ClinicalTrials.gov ↗ ← All trials in Canada