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

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.

Conditions

• 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

Interventions

DRUG

Chemotherapy

Receive standard of care chemotherapy

PROCEDURE

Laparotomy

Undergo laparotomy

PROCEDURE

Minimally Invasive Surgery

Undergo MIS

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Jose A Rauh-Hain · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-05

Primary Completion

2028-12-31

Completion

2028-12-31

FDA Drug

Yes

Countries

• United States
• Canada
• Italy
• Mexico
• Netherlands

Study Locations