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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

Must not have

Evidence of tumor not amenable to minimally invasive resection on pre-operative imaging (CT, PET-CT, or MRI)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between randomization and death (all causes), assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My scans show my tumor can't be removed with a minor surgery.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and between randomization and death (all causes), assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease free survival (DFS)

Secondary study objectives

Complete cytoreduction

Cost of the procedure

Health related-quality of life (HR-QoL)

+6 more

Awards & Highlights

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.

Trial 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