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Chemotherapy
Minimally Invasive Surgery vs Laparotomy After Chemotherapy for Ovarian and Related Cancers
Phase 3
Recruiting
Led By Jose A Rauh-Hain
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years old
Diagnosed with 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between randomization and death (all causes), assessed up to 5 years
Awards & highlights
Study Summary
This trial is comparing two different surgeries for ovarian, primary peritoneal, or fallopian tube cancer patients who are also receiving chemotherapy. One surgery is minimally invasive and the other is laparotomy. They are checking to see if the minimally invasive surgery is just as good or better than the laparotomy in prolonging the return of the disease and/or improving quality of life after surgery.
Who is the study for?
This trial is for adults over 18 with advanced ovarian, primary peritoneal, or fallopian tube cancer who've had some success with chemotherapy. They should be fit enough for surgery and have no other active cancers (except certain skin cancers). Pregnant women and those unable to undergo minimally invasive surgery due to health reasons are excluded.Check my eligibility
What is being tested?
The LANCE trial is comparing two surgical methods after initial chemotherapy: a less invasive approach using small cuts (MIS) versus traditional open surgery (laparotomy). The goal is to see if MIS can extend the time before the cancer returns and improve life quality post-surgery.See study design
What are the potential side effects?
Surgical side effects may include pain, bleeding, infection risk at incision sites, potential complications from anesthesia, and longer recovery times especially associated with laparotomy. Specific risks of MIS could involve issues related to small incisions or prolonged positioning during surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have advanced high-grade ovarian, peritoneal, or fallopian tube cancer.
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I can take care of myself and perform daily activities.
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I have had no other cancers except skin cancer in the last 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between randomization and death (all causes), assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between randomization and death (all causes), assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease free survival (DFS)
Secondary outcome measures
Complete cytoreduction
Cost of the procedure
Health related-quality of life (HR-QoL)
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (MIS, standard of care chemotherapy)Experimental Treatment4 Interventions
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.
Group II: Arm B (laparotomy, standard of care chemotherapy)Active Control4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Minimally Invasive Surgery
2010
N/A
~70
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,786,741 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,301 Total Patients Enrolled
Jose A Rauh-HainPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
1,456 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You can't stay in a tilted position for a long time, or handle having air pumped into your abdomen, as determined by the doctors at the hospital.You must have a negative pregnancy test within 14 days before the surgery.My surgery is scheduled within 6 weeks after my last chemotherapy.I have advanced high-grade ovarian, peritoneal, or fallopian tube cancer.My doctor has not identified any reasons I can't have minimally invasive surgery.My scans show my tumor can't be removed with a minor surgery.My CA-125 levels are normal or below 500, and I am scheduled for a diagnostic procedure before surgery.I am eligible for surgery after chemotherapy, with no cancer outside my abdomen or minor pleural effusions.I can take care of myself and perform daily activities.I have had no other cancers except skin cancer in the last 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (MIS, standard of care chemotherapy)
- Group 2: Arm B (laparotomy, standard of care chemotherapy)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What was the most recent government decision regarding chemotherapy?
"Chemotherapy has received a safety rating of 3 from our team at Power. This is because Phase 3 trials have found some evidence supporting efficacy and multiple rounds of data support Chemotherapy's safety."
Answered by AI
Are new volunteers still being sought for this trial?
"The clinical trial is currently ongoing and actively recruiting patients, with an initial posting date of 8/5/2020 and most recent edit on 7/11/2022. This specific study is looking for 580 participants at 1 site."
Answered by AI
How many people are allowed to join this clinical trial?
"Yes, that is accurate. The latest information on clinicaltrials.gov shows that this trial was posted on 8/5/2020 and updated as recently as 7/11/2022. They are looking for 580 participants at 1 medical facility."
Answered by AI
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