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

Last updated: March 12, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

3

Condition

Peritoneal Cancer

Ovarian Cysts

Digestive System Neoplasms

Treatment

Questionnaire Administration

Laparotomy

Chemotherapy

Clinical Study ID

NCT04575935
2020-0165
2020-0165
NCI-2020-04165
  • Ages > 18
  • Female

Study 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

Inclusion Criteria:

  • Age ≥ 18 years old

  • Stage IIIC or IV, high-grade (serous, endometrioid, clear-cell, transitionalcarcinomas), invasive epithelial ovarian carcinoma, primary peritoneal carcinoma, orfallopian-tube carcinoma or pathology consistent with high-grade mulleriancarcinoma.

  • Patient is considered by treating physician to be a surgical candidate aftercompletion of 3 to 4 cycles of platinum-based chemotherapy, or an investigationalneoadjuvant regimen given according to protocol, with complete radiologic resolutionof any disease outside the abdominal cavity. Pleural effusions are acceptable perthe 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-125cannot exceed 35 U/mL at the completion of NACT prior to interval debulkingsurgery.) or has a CA-125 value ≤500 and is scheduled to undergo a diagnosticlaparoscopy prior to debulking surgery. a. For patients undergoing diagnosticlaparoscopy, surgeon considers that optimal debulking is feasible either by MIS orlaparotomy.

  • Timeframe of < 6 weeks (42 days) from the last cycle of NACT to interval debulkingsurgery. 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 basaland squamous cell carcinomas of the skin

Exclusion

Exclusion Criteria:

  • Evidence of tumor not amenable to minimally invasive resection on pre-operativeimaging (CT, PET-CT, or MRI) including but not limited to the following findingsthat may preclude minimally invasive resection per surgeon's assessment. • Failureof improvement of ascites during NACT (trace ascites is allowed) • Small bowel orgastric tumor involvement • Colon or rectal tumor involvement • Diaphragmatic tumorinvolvement • 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 conditionpotentially preventing compliance with the study protocol and follow-up schedule

  • Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum as deemedby participating institution's clinicians

  • Any other contraindication to MIS as assessed by the clinician

Study Design

Total Participants: 580
Treatment Group(s): 5
Primary Treatment: Questionnaire Administration
Phase: 3
Study Start date:
August 05, 2020
Estimated Completion Date:
December 31, 2028

Study Description

PRIMARY OBJECTIVE:

I. To examine whether MIS is non-inferior to laparotomy in terms of disease free survival (DFS) in women with advanced stage epithelial ovarian cancer (EOC) that received 3 to 4 cycles of neoadjuvant chemotherapy (NACT).

SECONDARY OBJECTIVES:

I. To determine if there are differences in health-related quality of life (HR-QoL) in patients undergoing MIS versus (vs) laparotomy as assessed with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30), QLQ-Ovarian Cancer Module (OV28), and Functional Assessment of Cancer Therapy-General (FACT-G7).

II. To determine if there are differences between patients undergoing MIS vs laparotomy in the rate of optimal cytoreduction (defined as residual tumor nodules each measuring 1 cm or less in maximum diameter) and complete cytoreduction (defined as no evidence of macroscopic disease).

III. To examine whether MIS is non-inferior to laparotomy in terms of overall survival (OS) in women with advanced stage EOC that received 3 to 4 cycles of NACT.

IV. To determine if there are differences between patients undergoing MIS vs laparotomy in surgical morbidity and mortality, intraoperative injuries, and post-operative complications.

V. To determine the rates of MIS converted to laparotomy and the reasons.

VI. To determine if there are any difference in costs and cost-effectiveness between patients undergoing MIS vs laparotomy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients undergo MIS within 6 weeks after last cycle of standard of care neoadjuvant chemotherapy. If during MIS the surgeon thinks complete gross resection can only be accomplished by performing an open procedure, patients may undergo laparotomy instead. Within 6 weeks after surgery, patients receive standard of care chemotherapy.

ARM B: Patients undergo laparotomy within 6 weeks after last cycle of standard of care neoadjuvant chemotherapy. Within 6 weeks after surgery, patients receive standard of care chemotherapy.

After completion of study, patients are followed up within 6 weeks of completing post-surgery chemotherapy, then every 3 months for the first 2 years, and then every 6 months for 3 years.

Connect with a study center

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York 10032
    United States

    Active - Recruiting

  • Duke

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Lyndon Baines Johnson General

    Houston, Texas 77026
    United States

    Active - Recruiting

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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