Minimally Invasive Surgery for Advanced Ovarian Cancer

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

Recruiting Phase 3 Interventional Study
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
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
580 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
Who this trial is looking for

This trial is looking for adults with stage IIIC-IV ovarian, fallopian tube, or primary peritoneal cancer who have completed chemotherapy. Participants will receive either a minimally invasive surgery or traditional surgery to remove tumors.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have stage IIIC or IV high-grade ovarian or related cancer.
  • I have completed 3 to 4 cycles of chemotherapy before surgery.
  • My cancer has shown no spread outside the abdominal cavity.
  • I have a CA-125 level that meets the study requirements.
  • I can undergo surgery within 6 weeks of my last chemotherapy.
  • I have a good performance status (ECOG 0-2).
  • I am not currently pregnant.

You may not be able to join if

  • I have tumors that cannot be removed with minimally invasive surgery.
  • I have issues that would prevent me from following the study protocol.
  • I cannot tolerate conditions required for this surgery.
  • I have another active cancer except for certain skin cancers.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 s…
Trial Locations
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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. * Patien…
Contacts

Jose A. Rauh-Hain, MD, MPH

713-794-1759

jarauh@mdanderson.org

CONTACT