What side effects are associated with this type of intervention?

Common treatments for endometrial cancer include surgery, radiation therapy (RT), chemotherapy, and vaginal brachytherapy (VBT). Surgery, particularly with the use of intrauterine manipulators like Vcare®, may increase the risk of spreading cancer cells to the peritoneal cavity. Radiation therapy can lead to long-term urinary and bowel symptoms, as well as sexual dysfunction. Chemotherapy is associated with systemic side effects such as hematologic toxicity, neurotoxicity, and fatigue. Vaginal brachytherapy (VBT) is generally less toxic than pelvic RT but can still cause local side effects. Each treatment modality has its own risk profile, and the choice of treatment should be tailored to the individual patient's condition and needs.

What prior FDA approvals exist?

FDA-approved treatments for endometrial cancer include a variety of surgical, chemotherapeutic, and radiotherapeutic options. Surgical management often involves hysterectomy with or without lymph node dissection. Chemotherapy regimens typically include drugs like paclitaxel, carboplatin, and doxorubicin. Radiotherapy options include external beam radiation therapy (EBRT) and vaginal brachytherapy (VBT). These treatments aim to manage and reduce the spread of cancer cells, similar to the concerns addressed in the trial involving the Vcare® intrauterine manipulator, which investigates the potential spread of cancer cells to the peritoneal cavity during surgical procedures.

What other types of research exist?

Promising alternatives to the Vcare® intrauterine manipulator for endometrial cancer patients may include advanced laparoscopic tools and robotic-assisted surgery techniques that minimize intrauterine manipulation and reduce the risk of spreading cancer cells to the peritoneal cavity.

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Intrauterine Manipulation for Endometrial Cancer

N/A

Recruiting

Led By Okechukwu Ibeanu, MD

Research Sponsored by WellSpan Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No clinical evidence of disseminated intraperitoneal disease

Planned standard of care surgical management of early stage endometrial cancer

Must not have

Subject is not a surgical candidate

Subject is unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates whether using the Vcare® tool during surgery affects the presence of cancer cells in patients with early-stage endometrial cancer. The tool helps surgeons by stabilizing the uterus, aiming for more efficient and safe surgeries.

Who is the study for?

This trial is for adults over 18 with diagnosed endometrial cancer who are able to consent and are set for standard surgical treatment without signs of widespread disease in the abdomen. It's not for those whose final pathology isn't endometrial cancer, have spread of cancer within the abdomen, can't undergo surgery, or choose non-surgical management.

What is being tested?

The study investigates if using a Vcare® intrauterine manipulator during surgery increases the chance of finding cancer cells in the abdominal fluid in early stage (FIGO I/II) endometrial cancer patients.

What are the potential side effects?

Since this trial focuses on a surgical procedure rather than a drug, side effects may include typical risks associated with surgery such as infection, bleeding, or injury to surrounding organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has not spread within my abdomen.

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I am scheduled for surgery for early stage endometrial cancer.

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I have been diagnosed with endometrial cancer through a biopsy.

Exclusion Criteria

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

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I cannot undergo surgery for my condition.

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I am unable to understand and give consent for treatment.

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My cancer has spread within my abdomen.

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My final pathology report does not show any form of endometrial cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Conversion of positive peritoneal cytology

Secondary study objectives

Recurrence rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: V-care uterine manipulatorExperimental Treatment1 Intervention

Patients in the V-care uterine manipulator arm will undergo standard staging surgery utilizing a V-care uterine manipulator in the standard fashion

Group II: Sponge stickActive Control1 Intervention

Patients in the sponge stick arm will undergo standard staging surgery utilizing a non-invasive sponge stick for cervical delineation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

surgical staging

2022

N/A

~460

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endometrial cancer include surgery, radiation therapy, and chemotherapy. Surgery, often a hysterectomy, aims to remove the uterus and sometimes nearby tissues to eliminate the primary tumor. Radiation therapy, such as pelvic radiation therapy (RT) and vaginal brachytherapy (VBT), uses high-energy rays to destroy cancer cells and prevent local recurrence. Chemotherapy, using drugs like paclitaxel and carboplatin, targets rapidly dividing cells to eliminate any remaining cancer cells after surgery. The use of uterine manipulators during surgery, like the Vcare® device, is significant because it may increase the risk of spreading cancer cells to the peritoneal cavity, potentially leading to recurrence. Understanding these mechanisms is crucial for patients and clinicians to make informed treatment decisions and manage associated risks.

Role of uterine manipulator during laparoscopic endometrial cancer treatment.Do cancer therapies damage the uterus and compromise fertility?The effect of a uterine manipulator on the recurrence and mortality of endometrial cancer: a multi-centric study by the Italian Society of Gynecological Endoscopy.