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

Launched by M.D. ANDERSON CANCER CENTER · Sep 29, 2020

Keywords

ClinConnect Summary

The LANCE Trial is a study looking at two types of surgery for women with advanced ovarian, primary peritoneal, or fallopian tube cancer. The trial compares minimally invasive surgery (MIS), which uses small cuts to reduce pain and recovery time, to the traditional laparotomy, which involves a larger incision. Both surgeries are performed after patients receive chemotherapy before surgery. The goal is to see if MIS can be just as effective or even better than laparotomy in managing the disease and improving patients' quality of life.

To participate in the trial, women must be at least 18 years old and have specific types of advanced cancer (stage IIIC or IV). They should have completed 3 to 4 cycles of chemotherapy and show signs of improvement in their condition. Participants can expect to undergo surgery within about six weeks after finishing chemotherapy and will be closely monitored throughout the process. It’s important to know that not everyone will be eligible; for example, patients with certain complications or other health issues may not qualify for the minimally invasive approach.

Gender

FEMALE

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