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New treatment option for Advanced Ovarian Carcinoma
Official title Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
ClinicalTrials.gov ID: NCT04575935
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced ovarian carcinoma.
Also referred to as Chemo, Chemotherapy (NOS).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Age ≥ 18 years old
- Stage IIIC or IV, high-grade (serous, endometrioid, clear-cell, transitional carcinomas), invasive epithelial ovarian carcinoma, primary peritoneal...
- Patient is considered by treating physician to be a surgical candidate after completion of 3 to 4 cycles of platinum-based chemotherapy, or an...
- Normalization of CA-125 according to individual participating center reference range (Note: Among patients with a normal CA-125 at initiation of...
- 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...
You likely can't join if
- Evidence of tumor not amenable to minimally invasive resection on pre-operative imaging (CT, PET-CT, or MRI) including but not limited to the...
- History of psychological, familial, sociological or geographical condition potentially preventing compliance with the study protocol and follow-up...
- 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
See the full eligibility 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...
- 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...
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Weston, Florida, United States
- Boston, Massachusetts, United States
- Mineola, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Bethlehem, Pennsylvania, United States
- Houston, Texas, United States
- Madison, Wisconsin, United States
- Calgary, Canada
- Toronto, Canada
- Bologna, Italy
- Rome, Italy
- Tlalpan, Mexico
- Amsterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Weston, Florida, United States; Boston, Massachusetts, United States; Mineola, New York, United States; New York, New York, United States; Durham, North Carolina, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.