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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

StatusRecruiting
PhasePhase 3
Started2020-08-05
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
minor
Study Status v13
Re-verified, no change to tracked fields
2026-03-03
minor
Study Status, Contacts/Locations v12
Study sitescontacts updated at 1 of 19 sites
2025-09-09
minor
Study Status, Contacts/Locations v11
Study sitescontacts updated at 1 of 19 sites
2025-08-29
minor
Study Status, Contacts/Locations v10
Study sites7→19
2025-03-12
minor
Study Status, Contacts/Locations v9
Study sites6→7
Show 8 earlier versions
2024-12-16
minor
2 amendments v7-v8
2 re-verifications since 2024-05-17, no change to tracked fields
2023-10-27
minor
Study Status, Eligibility v6
Eligibility criteria+272 characters
Inclusion Criteria: Age ≥ 18 years old Stage IIIC or IV, high-grade (serous, endometrioid, clear-ce [...] pian-tube carcinoma or pathology consistent with high-grade Mullerianmullerian carcinoma. CompletePatient oris partialconsidered responseby treating physician to be a surgical candidate after completion of 3 orto 4 cycles of NACTplatinum-based (clinicalchemotherapy, responseor willan beinvestigational assessedneoadjuvant byregimen clinicalgiven radiologistaccording atto each siteprotocol, with Responsecomplete Evaluationradiologic Criteria in Solid Tumors [RECIST] 1.1 guidance provided) Patients [...] [...]
2023-10-26
minor
Study Status v5
Re-verified, no change to tracked fields
2023-06-29
minor
Study Status v4
Primary completion date2023-05-15→2028-12-31
Completion date2023-05-15→2028-12-31
2023-03-20
minor
Study Status, Contacts/Locations v3
Study sites1→6
2022-07-11
minor
Study Status, References v2
Re-verified, no change to tracked fields
2020-10-03
minor
Study Status, Outcome Measures v1
Secondary endpointsdetails revised at 2 of 12 entries
2020-09-29
minor
Original filing
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.
Trial Details
NCT Number NCT04575935
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
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 +17 more
Enrollment 580 participants
Start Date 2020-08-05
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-14