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NCT04575935 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Ovarian Endometrioid Adenocarcinoma and Advanced Ovarian Carcinoma, sponsored by M.D. Anderson Cancer Center.

Recruiting
Registry status
Phase 3
Development phase
580
Enrollment target
19
Study locations

NCT04575935 is a Phase 3 study of Ovarian Endometrioid Adenocarcinoma and Advanced Ovarian Carcinoma that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 580 participants, above the 263-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (121% higher). The trial reports 19 study locations across 9 states.

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The verdict

NCT04575935, a Phase 3 study of Ovarian Endometrioid Adenocarcinoma and Advanced Ovarian Carcinoma, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.

RECRUITING
Registry status
Phase 3
Development phase
580 participants
Enrollment target
19
Study locations

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.

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Questionnaire Administration
  • DRUG Chemotherapy
  • PROCEDURE Minimally Invasive Surgery
  • PROCEDURE Laparotomy

Study Locations (19)

Other

  • Arthur J.E. Child Comprehensive Cancer Centre - Calgary - Calgary
  • University Health Network - Princess Margaret Cancer Centre - Toronto
  • Sant'Orsola Hospital di Bologna - Bologna
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Rome
  • Instituto Nacional de Cancerología (Mexico) - Tlalpan
  • Amsterdam UMC - Locatie AMC | H5Zuid 154 - Amsterdam

Texas

  • Lyndon Baines Johnson General - Houston
  • Houston Methodist - Houston
  • M D Anderson Cancer Center - Houston

Florida

  • University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
  • Cleveland Clinic Foundation - Florida - Weston

Massachusetts

  • Massachusetts General Hospital - Boston
  • Dana Farber Cancer Institute - Boston

New York

  • NYU Langone Health - Mineola
  • Columbia University Medical Center - New York

North Carolina

  • Duke - Durham

Ohio

  • Cleveland Clinic - Cleveland

Pennsylvania

  • St. Luke's University Health Network - Bethlehem

Trial Details

FieldValue
Enrollment Target 580 participants
Start Date 2020-08-05
Est. Completion 2028-12-31
Phase Phase 3

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT04575935

The ClinicalTrials.gov registry entry for NCT04575935 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 580 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 263-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (121% higher). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Ovarian Endometrioid Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.

NCT04575935 reports 19 study locations spanning 9 distinct geographic areas - top geographies include Other, Texas, Florida.

Frequently Asked Questions

What is clinical trial NCT04575935 about?

NCT04575935 is a clinical study titled "Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial". 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 i...

What is the current status of trial NCT04575935?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 580 participants. The study started on 2020-08-05. Estimated completion is 2028-12-31.

What conditions does trial NCT04575935 study?

This clinical trial studies the following conditions: Ovarian Endometrioid Adenocarcinoma, Advanced Ovarian Carcinoma, Ovarian Serous Adenocarcinoma, Ovarian Clear Cell Adenocarcinoma, Fallopian Tube Clear Cell Adenocarcinoma.

What interventions are being tested in trial NCT04575935?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Chemotherapy (DRUG), Minimally Invasive Surgery (PROCEDURE), Laparotomy (PROCEDURE).

Who is sponsoring clinical trial NCT04575935?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04575935 being conducted?

This trial has 19 study locations across Florida, Massachusetts, New York, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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