Clinical trial · Interventional
Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (25)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Fallopian Tube Clear Cell Adenocarcinoma | Fallopian Tube Clear Cell Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Fallopian Tube Endometrioid Tumor | Fallopian Tube Endometrioid Tumor | ONTOLOGY_EXACT | 0.98 |
| Fallopian Tube Serous Neoplasm | Fallopian Tube Serous Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Fallopian Tube Transitional Cell Carcinoma | Fallopian Tube Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Clear Cell Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Endometrioid Adenocarcinoma |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Laparotomy | Procedure | — | UNRESOLVED |
| Minimally Invasive Surgery | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (MIS, standard of care chemotherapy)
- description
- 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.
- interventionNames
- Drug: Chemotherapy
- Procedure: Minimally Invasive Surgery
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm B (laparotomy, standard of care chemotherapy)
- description
- 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.
- interventionNames
- Drug: Chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRauh-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. PMID 39570589