International clinical trial conducts head-to-head comparison of open versus minimally invasive surgery for early-stage cervical cancer

(Press-News.org) COLUMBUS, Ohio – Gynecologic surgeons with The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) are leading an international clinical trial to determine whether minimally invasive surgery robotic surgery is better or worse than open surgery when performing a radical hysterectomy to treat cervical cancer.

Although minimally invasive and robotic-assisted surgery techniques have become the standard approach for many surgeries, in gynecologic cancer open surgery – which involves one large incision versus several keyhole-sized incisions­ – has remained the standard practice for radical hysterectomy.

Radical hysterectomy is a procedure that involves removal of the uterus, cervix, parametria (tissue beside the cervix) and upper part of the vagina with lymphadenectomy, an additional procedure required for treatment of early-stage cervical cancer.

The preference for an open approach to radical hysterectomy is in direct response to a 2018 study published in the New England Journal of Medicine – known as the Laparoscopic Approach to Cervical Cancer (LACC) trial ­­– which reported concerns over increased risk for cancer recurrence and death in women undergoing minimally invasive surgery for cervical cancer.

In this new international study sponsored by the Gynecologic Oncology Group, researchers hypothesize that minimally invasive, robotic-assisted radical hysterectomy is not inferior to open surgery when appropriate tumor containment methods are utilized and intrauterine manipulators are avoided. If proven, this would refute the LACC trial that led to a dramatic shift away from minimally invasive surgery.

Kristen Bixel, MD, a gynecologic oncologist with the OSUCCC – James, strongly believes that minimally invasive surgery should be re-evaluated as an option for patients with early-stage cervical cancer. She notes having this surgery through a minimally invasive approach could be especially impactful for young women living with the long-term impact of treatment for cervical cancer.

“Studies have proven that robotic surgery results in less pain, fewer deaths and fewer surgical complications. We have greater knowledge now of how to reduce risk of recurrence through standardized tumor containment techniques, introduction of preoperative imaging and other standardized methodologies. Women deserve a better option than open surgery,” said Bixel, who serves as one of four international co-principal investigators along with colleague Allison Quick, MD.

“Criticisms of the LACC trial include lack of uniform preoperative imaging and assessment, use of transcervical uterine manipulators and lack of proper tumor containment, leading to peritoneal contamination. Subsequent retrospective studies have reported conflicting results,” said Bixel. “Our study addresses all the limitations of the LACC trial.”

For this study, gynecologic oncologists at more than 80 centers across the United States and Canada will enroll up to 840 patients. Patients will be randomized to have a radical hysterectomy via standard open technique or to a study arm in which they will receive a radical hysterectomy via standard robotic technique, but with new protective maneuvers around proper tumor containment and preoperative imaging and assessment.

A Data Safety Monitoring Committee will conduct periodic reviews of safety, including two planned formal interim analyses for harm after accrual of 370 and 640 patients. Patients will be followed for three years to monitor for cancer recurrence.

“Results of this trial could potentially alter the surgical approach to treatment of early-stage cervical cancer,” said Bixel. “With strict patient-selection criteria and protective surgical maneuvers to prevent tumor exposure to the peritoneal cavity at the time of minimally invasive radical hysterectomy, we may be able to optimize oncologic outcomes, reduce complications and improve perioperative recovery in women with early-stage cervical cancer.”

To learn more about participating in clinical research at the OSUCCC – James, visit cancer.osu.edu/clinicaltrials or call 1-800-293-5066. Information about this specific study can be found here.

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