NCT04575935 Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
| NCT ID | NCT04575935 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Advanced Ovarian Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 580 participants |
| Start Date | 2020-08-05 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 580 participants in total. It began in 2020-08-05 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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. * 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
Contact & Investigator
Jose A Rauh-Hain
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT04575935 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Advanced Ovarian Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04575935 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 580 participants.
Is NCT04575935 currently recruiting?
Yes, NCT04575935 is actively recruiting participants. Contact the research team at jarauh@mdanderson.org for enrollment information.
Where is the NCT04575935 trial being conducted?
This trial is being conducted at Miami, United States, Weston, United States, Boston, United States, Boston, United States and 11 additional locations.
Who is sponsoring the NCT04575935 clinical trial?
NCT04575935 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Jose A Rauh-Hain at M.D. Anderson Cancer Center. The trial plans to enroll 580 participants.