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.
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
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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