RecruitingNot ApplicableNCT03719547

Robot-assisted Approach to Cervical Cancer


Sponsor

Karolinska Institutet

Enrollment

800 participants

Start Date

May 28, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the RACC trial is to compare the oncologic outcome defined as recurrence-free survival (RFS) between robot-assisted and open radical hysterectomy for the treatment of early stage cervical cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing robot-assisted surgery versus standard open or laparoscopic surgery for treating early-stage cervical cancer (cancer of the opening of the uterus), to evaluate whether the robotic approach is as safe and effective as traditional surgical methods. **You may be eligible if...** - You are 18 or older - You have been diagnosed with early-stage cervical cancer (stage IB or IIA1) confirmed by biopsy - Your cancer is one of three cell types: adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma - You are a suitable candidate for surgery - Your tumor is 4 cm or smaller - Your blood counts and organ function are adequate **You may NOT be eligible if...** - Your cancer is more advanced (stage IIB or higher) or has spread to lymph nodes or other organs - Your tumor is larger than 4 cm - You have had prior pelvic or abdominal radiation therapy - You are pregnant - You have had another cancer in the past 5 years (with limited exceptions) - You are unable to tolerate the surgical position required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAbdominal radical hysterectomy

Radical hysterectomy (type B or C according to the Querleu\&Morrow classification) with pelvic lymphadenectomy

PROCEDURERobot-assisted radical hysterectomy

Radical hysterectomy (type B or C according to the Querleu\&Morrow classification) with pelvic lymphadenectomy

DIAGNOSTIC_TESTSentinel lymph node biopsy

Assessment of sentinel lymph nodes using either radiotracer or indocyanine green (ICG)


Locations(1)

Karolinska University Hospital

Stockholm, Sweden

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NCT03719547


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