Patient Research
Sign in
All studies
RecruitingPHASE3INTERVENTIONAL

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

This research study, called the LANCE Trial, is looking at the best way to do surgery for women with advanced ovarian, fallopian tube, or primary peritoneal cancer. These cancers are often treated with chemotherapy first, then surgery. The study compares two types of surgery: keyhole surgery (minimally invasive surgery), which uses small cuts, and traditional open surgery (laparotomy), which uses a larger cut. The main goal is to see if keyhole surgery is just as good as open surgery in preventing the cancer from coming back, and if it helps improve a woman's quality of life after treatment. Participants will be carefully monitored throughout the study.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
M.D. Anderson Cancer Center
Enrolment target
580
Start
05 Aug 2020
Estimated completion
31 Dec 2028
Advanced Ovarian CarcinomaFallopian Tube Clear Cell AdenocarcinomaFallopian Tube Endometrioid TumorFallopian Tube Serous NeoplasmFallopian Tube Transitional Cell CarcinomaOvarian Clear Cell AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Serous AdenocarcinomaOvarian Transitional Cell CarcinomaPrimary Peritoneal Clear Cell AdenocarcinomaPrimary Peritoneal Endometrioid AdenocarcinomaPrimary Peritoneal Serous AdenocarcinomaPrimary Peritoneal Transitional Cell CarcinomaStage IIIC Fallopian Tube Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage IIIC Primary Peritoneal Cancer AJCC v8Stage IV Fallopian Tube Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Primary Peritoneal Cancer AJCC v8Stage IVA Fallopian Tube Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Primary Peritoneal Cancer AJCC v8Stage IVB Fallopian Tube Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8Stage IVB Primary Peritoneal Cancer AJCC v8

What is this study about?

When women are diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer, it often means the cancer has spread. Treatment usually involves chemotherapy, which is medicine that kills cancer cells, followed by surgery. The surgery aims to remove as much of the cancer as possible. There are different ways to do this surgery, and doctors are always looking for the safest and most effective methods that also help patients recover well.

This study is looking at two main types of surgery. One is called 'minimally invasive surgery' (MIS), often known as keyhole surgery. This involves making a few small cuts and using special instruments and a camera to remove the cancer. The idea behind keyhole surgery is that it might lead to less pain, less bleeding, and a quicker recovery because the cuts are smaller. The other type is 'laparotomy,' which is standard open surgery, involving a larger cut in the tummy area to allow the surgeon to see and work directly on the affected areas.

The LANCE Trial wants to find out if keyhole surgery is at least as effective as open surgery in stopping the cancer from returning for as long as possible. They also want to understand if keyhole surgery improves a woman's everyday life after surgery, looking at things like pain, energy, and overall wellbeing. This information will help doctors decide the best surgical approach for women in the future, aiming to give them the best chance for recovery and a good quality of life.

Key takeaways

  • This study compares keyhole surgery with open surgery for advanced ovarian cancer.
  • It's for women who have already received initial chemotherapy.
  • The aim is to see if keyhole surgery is as effective and improves recovery/quality of life.
  • You will be randomly assigned to one of the two surgery groups.
  • Your health and wellbeing will be closely monitored throughout.
  • Participation could help improve future treatments for this type of cancer.

Who may be eligible?

This study is looking for women who are at least 18 years old and have advanced ovarian, primary peritoneal, or fallopian tube cancer. You must have already had 3 or 4 rounds of chemotherapy for your cancer. Your doctor needs to believe that surgery would be helpful for you after the chemotherapy, and any cancer that was outside your tummy area should have gone or improved significantly.

Your blood test for CA-125 (a marker for ovarian cancer) should be back to a normal level for you, or below a certain level if you're having another procedure first. You must be well enough to take part in the study and be able to come to follow-up appointments. You should not have had other active cancers in the last five years, apart from some skin cancers.

Unfortunately, you cannot take part if scans show that your cancer cannot be removed easily using keyhole surgery, for example, if there's extensive cancer in your bowel or stomach, or if certain problems like fluid build-up in your tummy haven't improved with chemotherapy.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have advanced ovarian, fallopian tube, or primary peritoneal cancer?
  3. Have you already had 3 or 4 rounds of chemotherapy?
  4. Does your doctor think you're well enough for surgery?
  5. Can you attend follow-up appointments?
  6. Do you not have other active cancers (excluding some skin cancers)?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups, like flipping a coin. You'll either have minimally invasive surgery (keyhole surgery) or traditional open surgery (laparotomy). Both surgeries will happen within six weeks of your last chemotherapy treatment. If you're in the keyhole surgery group, but the surgeon thinks open surgery would be better at that moment to remove all the cancer, they might switch to open surgery.

After your surgery, you will have more standard chemotherapy within six weeks. Throughout the study, you'll be asked to fill out questionnaires about how you're feeling and your quality of life. The study doctors will also keep a close eye on your health, check for any problems from the surgery, and see how your cancer responds to treatment over time. The exact number of visits and the total duration will be explained by the study team, but it includes careful monitoring and follow-up.

Potential risks and benefits

Taking part in this study could offer several potential benefits. For example, if you receive minimally invasive surgery, you might experience less pain, a shorter hospital stay, and a quicker return to your normal activities compared to open surgery. This study also helps us learn more about the best ways to treat advanced cancer, which could help future patients. However, there are potential risks with any surgery, including infection, bleeding, or complications from anaesthesia. There's also the chance that the keyhole surgery might need to be converted to open surgery during the operation. We don't know for sure if one type of surgery is better than the other in terms of cancer coming back. Remember, participation is completely voluntary; you can choose to withdraw from the study at any time without affecting your usual medical care.

Locations (19)

  • University of Miami Miller School of Medicine-Sylvester Cancer Center
    Verified postcode
    Miami, United States· Recruiting
  • Cleveland Clinic Foundation - Florida
    Verified postcode
    Weston, United States· Recruiting
  • Massachusetts General Hospital
    Verified postcode
    Boston, United States· Recruiting
  • Dana Farber Cancer Institute
    Verified postcode
    Boston, United States· Recruiting
  • NYU Langone Health
    Verified postcode
    Mineola, United States· Recruiting
  • Columbia University Medical Center
    Verified postcode
    New York, United States· Recruiting
  • Duke
    Verified postcode
    Durham, United States· Recruiting
  • Cleveland Clinic
    Verified postcode
    Cleveland, United States· Recruiting
  • St. Luke's University Health Network
    Verified postcode
    Bethlehem, United States· Recruiting
  • Lyndon Baines Johnson General
    Verified postcode
    Houston, United States· Recruiting
  • Houston Methodist
    Verified postcode
    Houston, United States· Recruiting
  • M D Anderson Cancer Center
    Verified postcode
    Houston, United States· Recruiting

Common questions

What does 'advanced ovarian cancer' mean?

It means the cancer has grown beyond the initial area and may have spread to other nearby parts of the body or sometimes further away.

What is 'chemotherapy'?

Chemotherapy is a type of medicine that helps kill cancer cells throughout your body. In this study, it's given before surgery to shrink the cancer.

What's the difference between 'keyhole surgery' and 'open surgery'?

Keyhole surgery uses several small cuts and special tools, while open surgery involves one larger cut to get to the area being operated on.

Will I get to choose which type of surgery I have?

No, you will be randomly assigned to one of the two surgery groups, like drawing lots, to make the study fair.

What does 'quality of life' mean in this study?

It refers to how well you feel and function in your daily life after treatment, including your physical comfort, emotions, and overall wellbeing.

How to find out more

Jose A. Rauh-Hain, MD, MPH

jarauh@mdanderson.org 713-794-1759 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Minimally Invasive Surgery After Neoadjuvant Chemotherapy fo…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.