Robotic vs Open Hysterectomy for Cervical Cancer

(ROCC Trial)

Recruiting in Palo Alto (17 mi)

+125 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: GOG Foundation

Disqualifiers: Neuroendocrine tumors, Stage II-IV, Metastatic disease, Prior radiotherapy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a randomized controlled trial to compare survival for patients who undergoe robotic assisted laparoscopy versus open hysterectomy and lymph node assessment for the treatment of early stage cervical cancer.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for guidance.

What data supports the effectiveness of the treatment da Vinci, Open Surgery, Open Radical Hysterectomy, Abdominal Hysterectomy, Laparotomy for cervical cancer?

Research shows that robotic radical hysterectomy, like the da Vinci system, is increasingly used for cervical cancer and may lead to less pain, fewer infections, and quicker recovery compared to open surgery. However, studies indicate no significant difference in survival rates between robotic and open radical hysterectomy for early-stage cervical cancer. ^{1 2 3 4 5}

Is robotic hysterectomy generally safe compared to open hysterectomy for cervical cancer?

Robotic radical hysterectomy for cervical cancer is generally considered safe and may lead to less pain, fewer infections, and a quicker recovery compared to open radical hysterectomy. However, more studies are needed to fully compare the safety of robotic, laparoscopic, and open surgeries. ^{1 2 6 7 8}

How does robotic radical hysterectomy differ from open radical hysterectomy for cervical cancer treatment?

Robotic radical hysterectomy is a newer approach that uses robotic assistance to perform the surgery, which can lead to less pain, fewer infections, shorter hospital stays, and quicker recovery compared to the traditional open radical hysterectomy. ^{1 2 3 4 7}

Research Team

Kristin Bixel, MD

Principal Investigator

Standford University

Eligibility Criteria

This trial is for adults over 18 with early-stage cervical cancer (specific types like adenocarcinoma, squamous cell carcinoma) who are fit for surgery and have no evidence of widespread cancer. They must be able to consent, have a uterus size suitable for vaginal delivery of the specimen, and an ECOG performance status of 0-1.

Inclusion Criteria

I am fully active or can carry out light work.

I am fit for surgery as per my recent lab tests and EKG.

Patient must have signed an approved informed consent and authorization permitting the release of personal health information

Exclusion Criteria

Patient with inability to receive an MRI

My cancer has spread to other parts of my body or lymph nodes.

My cancer is between stage 1A1 and stage IV according to FIGO 2018.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either robotic assisted laparoscopy or open hysterectomy and lymph node assessment for early stage cervical cancer

Surgery duration varies

1 visit (in-person for surgery)

Follow-up

Participants are monitored for disease-free survival and any postoperative complications

36 months

Regular follow-up visits as per protocol

Treatment Details

Interventions

• da Vinci (Robotic Surgery)
• Open Surgery (Surgery)

Trial Overview The study compares robotic-assisted laparoscopy using da Vinci technology versus traditional open radical hysterectomy in treating early-stage cervical cancer. It aims to see which method offers better survival rates.

Participant Groups

Group I: Robotic radical or simple hysterectomy Experimental Treatment 1 Intervention

Group II: Open radical or simple hysterectomy Active Control 1 Intervention

Who Is Running the Clinical Trial?

GOG Foundation

Lead Sponsor

Trials

48

Recruited

18,500+

Intuitive Foundation

Collaborator

Trials

2

Recruited

870+

Findings from Research

Robotic radical hysterectomy shows promise in treating cervical cancer, potentially leading to less pain, lower infection rates, shorter hospital stays, and fewer adhesions compared to traditional open surgery.

There is a need for prospective randomized controlled trials to directly compare the effectiveness and outcomes of robotic, laparoscopic, and open radical hysterectomy for cervical cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic radical hysterectomy. Fanning, J., Hojat, R., Johnson, J., et al.[2009]

Robotic radical hysterectomy for early-stage cervical cancer resulted in significantly shorter hospital stays (42.7 hours) and less blood loss (105.9 mL) compared to open radical hysterectomy (112.6 hours and 482.6 mL, respectively).

While both surgical methods had similar recurrence rates (10.1% for robotic vs. 10.4% for open), robotic surgery did not show a significant advantage in progression-free survival or overall survival, indicating comparable long-term oncologic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical and oncologic outcomes after robotic radical hysterectomy as compared to open radical hysterectomy in the treatment of early cervical cancer. Shah, CA., Beck, T., Liao, JB., et al.[2018]

Robotic-assisted laparoscopic radical hysterectomy for cervical cancer resulted in significantly less blood loss (165 mL) compared to open radical hysterectomy (323 mL), indicating a safer surgical option.

Patients undergoing robotic surgery had a shorter hospital stay (1.4 days) compared to those who had open surgery (2.8 days), suggesting improved recovery times with robotic assistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotically assisted laparoscopic radical hysterectomy compared with open radical hysterectomy. Geisler, JP., Orr, CJ., Khurshid, N., et al.[2018]

Robotic radical hysterectomy (RRH) resulted in a significantly lower complication rate (9.65%) compared to laparoscopic radical hysterectomy (LRH) (17.59%), indicating that RRH may be a safer surgical option for cervical cancer patients.

Both RRH and LRH showed similar overall survival rates and progression-free survival times, suggesting that while RRH may reduce complications, it does not compromise long-term outcomes compared to LRH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of robotic vs laparoscopic radical hysterectomy for cervical cancer. Chen, L., Liu, LP., Wen, N., et al.[2020]

In a study of 864 women with early-stage cervical cancer, both open and robotic radical hysterectomy showed similar long-term survival rates, with 5-year overall survival (OS) at 92% for open surgery and 94% for robotic surgery.

There were no significant differences in disease-free survival (DFS) between the two surgical methods, indicating that both approaches are equally effective in managing early-stage cervical cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No survival difference between robotic and open radical hysterectomy for women with early-stage cervical cancer: results from a nationwide population-based cohort study. Alfonzo, E., Wallin, E., Ekdahl, L., et al.[2020]

In a study of 243 cervical cancer patients who underwent radical hysterectomy, there was no significant difference in long-term complications between those who had robotic surgery and those who had open surgery followed by adjuvant radiation.

While robotic surgery showed a trend toward fewer adhesion-related complications, such as bowel obstruction, it also had a trend toward increased lymphedema compared to open surgery, indicating the need for further follow-up to assess long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the Robotic Platform Reduce Morbidity Associated With Combined Radical Surgery and Adjuvant Radiation for Early Cervical Cancers? Clark, LH., Barber, EL., Gehrig, PA., et al.[2018]

In a study of 333 women with early cervical cancer, those who underwent robotic radical hysterectomy had lower 5-year progression-free survival (79.0%) and overall survival (85.8%) compared to those who had open surgery (90.5% PFS and 95.3% OS).

Despite similar surgical radicality between the two methods, the robotic group experienced unique recurrence patterns, including port-site and peritoneal recurrences, and a shorter time to vaginal recurrence, indicating potential safety concerns with the robotic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival outcomes in patients with cervical cancer treated with open versus robotic radical hysterectomy: Our surgical pathology interrogation. Yang, J., Mead-Harvey, C., Polen-De, C., et al.[2021]

In a study involving 631 women with early cervical cancer, minimally invasive radical hysterectomy showed a similar overall incidence of intraoperative and postoperative adverse events compared to open radical hysterectomy, indicating comparable safety profiles for both surgical approaches.

Despite the similar rates of adverse events, the trial was suspended due to an increased risk of recurrence and death in the minimally invasive surgery group, highlighting potential concerns regarding long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of adverse events in minimally invasive vs open radical hysterectomy in early cervical cancer: results of a randomized controlled trial. Obermair, A., Asher, R., Pareja, R., et al.[2021]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Robotic radical hysterectomy. [2009]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Surgical and oncologic outcomes after robotic radical hysterectomy as compared to open radical hysterectomy in the treatment of early cervical cancer. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Robotically assisted laparoscopic radical hysterectomy compared with open radical hysterectomy. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Comparative analysis of robotic vs laparoscopic radical hysterectomy for cervical cancer. [2020]

5. England pubmed.ncbi.nlm.nih.gov

No survival difference between robotic and open radical hysterectomy for women with early-stage cervical cancer: results from a nationwide population-based cohort study. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Does the Robotic Platform Reduce Morbidity Associated With Combined Radical Surgery and Adjuvant Radiation for Early Cervical Cancers? [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Survival outcomes in patients with cervical cancer treated with open versus robotic radical hysterectomy: Our surgical pathology interrogation. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Incidence of adverse events in minimally invasive vs open radical hysterectomy in early cervical cancer: results of a randomized controlled trial. [2021]