Robotic vs Open Hysterectomy for Cervical Cancer

(ROCC Trial)

Recruiting at 128 trial locations

Overseen By Jennifer Klein, MEd

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: GOG Foundation

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgery duration varies

840 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which surgery better treats early-stage cervical cancer: robotic-assisted laparoscopy (using the da Vinci system) or traditional open surgery. Researchers will compare how these methods affect survival rates. Participants should have early-stage cervical cancer that hasn't spread, with a tumor size of 4 cm or less confirmed by an MRI. The study seeks individuals suitable for surgery who can agree to receive either treatment. As an unphased trial, it offers patients the chance to contribute to important research that could enhance surgical options for future patients.

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 prior data suggests that these surgical techniques are safe for treating cervical cancer?

Research has shown that robotic hysterectomy, such as using the da Vinci system, is generally safe for treating cervical cancer. Studies have found that this robotic method can lead to good outcomes for patients with early-stage cervical cancer. One study reported a high survival rate of 94% three years after surgery.

Additionally, research suggests that robotic hysterectomy might provide better surgical outcomes compared to some other methods. It is considered a safe and practical option for surgery. However, in a study of 333 women, those who underwent robotic surgery had a lower rate of being cancer-free five years after surgery, at 79.0%.

Overall, while robotic hysterectomy is generally well-tolerated, it's important to consider both the benefits and potential risks. Joining a clinical trial can help gather more information on its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic hysterectomy for cervical cancer because it offers precision and potentially quicker recovery times compared to traditional surgery. Unlike open surgery, which requires a larger incision, the robotic approach uses small incisions and advanced robotic arms, leading to less blood loss and reduced pain post-operation. Additionally, the enhanced visualization and dexterity provided by the robotic system can lead to more precise tumor removal, potentially improving outcomes for patients.

What evidence suggests that this trial's treatments could be effective for early stage cervical cancer?

This trial will compare robotic-assisted surgery with open surgery for treating early-stage cervical cancer. Research has shown that robotic-assisted surgery can be effective; one study found that 94% of patients were still alive three years after undergoing robotic surgery. Other studies have found that robotic surgery results in less blood loss and shorter hospital stays compared to traditional surgery. However, some data suggest that open surgery might offer a slightly higher chance of remaining cancer-free over time. Both methods have demonstrated good results, but each has its own advantages. ^{1 3 4 6 7}

Who Is on the Research Team?

Kristin Bixel, MD

Principal Investigator

Standford University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• da Vinci
• Open 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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11134290/

Efficacy and safety of robotic radical hysterectomy in cervical ... This meta-analysis aims to assess the clinical efficacy and safety of robot-assisted radical hysterectomy (RRH) for cervical cancer.

2. intuitive.com intuitive.com/en-us/about-us/company/research-outcomes

Da Vinci Research and Outcomes An analysis of 30 studies found that robotic-assisted (RAS) benign hysterectomy using the da Vinci system led to reduced blood loss and shorter hospital stays ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1015958421004681

Application of Da Vinci robotic surgery system in cervical ... Our study results demonstrated that the robotic surgical approach could achieve satisfying therapeutic outcomes in patients with early-stage cervical cancer.

4. ejgo.org ejgo.org/DOIx.php?id=10.3802/jgo.2017.28.e82

Surgical and oncologic outcomes after robotic radical ... Only one trial to date has looked at survival in women undergoing robotic surgery for cervical cancer, and they found an OS of 94% at 36 months ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1806395

Minimally Invasive versus Abdominal Radical ... The rate of disease-free survival at 4.5 years was 86.0% with minimally invasive surgery and 96.5% with open surgery, a difference of −10.6 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5671798/

Robotic-Assisted Radical Hysterectomy Results in Better ... The results from this study suggest that RRH is superior to TLRH with regard to surgical outcome and may pose a safe and feasible alternative to TLRH.

7. withpower.com withpower.com/trial/phase-3-uterine-cervical-neoplasms-7-2021-92402

Robotic vs Open Hysterectomy for Cervical Cancer 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 ...