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LANCE Trial: Minimally Invasive Surgery for Advanced Ovarian, Peritoneal, or Fallopian Tube Cancer

This study, called the LANCE trial, is comparing two types of surgery for women with advanced ovarian, primary peritoneal, or fallopian tube cancer (stage IIIC-IV) who have already received chemotherapy. You would either have minimally invasive surgery (MIS), which uses small cuts, or a laparotomy, which involves a larger incision to remove tumors. Researchers want to see if MIS is as good as or better than laparotomy in preventing the cancer from returning and improving your quality of life after surgery. The study is looking for 580 women aged 18 or older with these specific types of cancer. The main goal is to see how long you live without the disease coming back, up to 5 years after surgery.

Study design
This is an interventional study planning to enroll 580 women. It compares two surgical procedures after chemotherapy.
What's involved
You would receive standard chemotherapy and then undergo either a laparotomy or minimally invasive surgery. You would also complete quality-of-life assessments and questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Your disease-free survival will be assessed for up to 5 years after randomization.

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NCT04575935

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~580 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:ChemotherapyLaparotomyMinimally Invasive SurgeryQuality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
18 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease free survival (DFS)
Measured over Between randomization and physical or radiographic evidence of recurrence (local/distant) or death (all causes), assessed up to 5 years

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
Ovarian Transitional Cell Carcinoma
Primary Peritoneal Clear Cell Adenocarcinoma
Primary Peritoneal Endometrioid Adenocarcinoma
Primary Peritoneal Serous Adenocarcinoma
Primary Peritoneal Transitional Cell Carcinoma
Stage IIIC Fallopian Tube Cancer AJCC v8
Stage IIIC Ovarian Cancer AJCC v8
Stage IIIC Primary Peritoneal Cancer AJCC v8
Stage IV Fallopian Tube Cancer AJCC v8
Stage IV Ovarian Cancer AJCC v8
Stage IV Primary Peritoneal Cancer AJCC v8
Stage IVA Fallopian Tube Cancer AJCC v8
Stage IVA Ovarian Cancer AJCC v8
Stage IVA Primary Peritoneal Cancer AJCC v8
Stage IVB Fallopian Tube Cancer AJCC v8
Stage IVB Ovarian Cancer AJCC v8
Stage IVB Primary Peritoneal Cancer AJCC v8

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal Cancer

Where it's being run

19 sites across 12 states
Texas3
Florida2
Massachusetts2
New York2
Canada2
Italy2
North Carolina1
Ohio1

Study leadership

  • Jose A Rauh-Hain · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Jose A. Rauh-Hain, MD, MPH
[email protected]
713-794-1759
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Disease free survival (DFS)Between randomization and physical or radiographic evidence of recurrence (local/distant) or death (all causes), assessed up to 5 years

    Kaplan Meier curves will be used to describe DFS over time. Log-rank test will be used to compare DFS between the control and experimental arms. The treatment effects will be summarized by means of a hazard ratio with its associated 95% confidence interval. Two years DFS rate will be computed with a targeted 95% confidence interval (CI).