da Vinci for Cervical Cancers

Phase-Based Estimates
1
Effectiveness
1
Safety
Baystate Medical Center, Springfield, MA
+1 More
da Vinci - Device
Eligibility
18+
Female
Eligible conditions
Cervical Cancers

Study Summary

A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

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Eligible Conditions

  • Uterine Cervical Neoplasms
  • Cervical Cancers

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether da Vinci will improve 1 primary outcome in patients with Cervical Cancers. Measurement will happen over the course of 36 months.

36 months
Survival

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Open radical hysterectomy
Robotic radical hysterectomy

This trial requires 840 total participants across 2 different treatment groups

This trial involves 2 different treatments. Da Vinci is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Robotic radical hysterectomy
Device
Open radical hysterectomy
Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 36 months for reporting.

Closest Location

Baystate Medical Center - Springfield, MA

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell)
Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or imaging.
Patient must be age 18 years or older.
Patient must have ECOG performance status 0-1.
Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women.
Patient must have signed an approved informed consent and authorization permitting the release of personal health information. show original
Patient must have uterine size <12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator. show original
Patient must be suitable surgical candidate with preoperative assessments such as labs and EKG performed per institutional standard. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of cervical cancers?

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Signs of cervical cancers include abnormal bleeding with the appearance of a cervical mass, abnormal discharge, abnormal vaginal bleeding, itching, pain with intercourse, pelvic pain, burning pain with urination, pain with urination, cervical mass on exam, vaginal bleeding after intercourse, recurrent urinary tract infections, dyspareunia, dysuria, and urinary tract infections.

Unverified Answer

Can cervical cancers be cured?

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Treatment of [cervical cancer](https://www.withpower.com/clinical-trials/cervical-cancer) is currently limited to surgery and radiation therapy. However, recent discoveries indicate that cervical cancers are often curable. Using recent approaches to immunotherapy, which have been successful in treating cancers in other organs, we propose that cervical cancer treatment may become a realistic and achievable goal for patients with curable disease.

Unverified Answer

What are common treatments for cervical cancers?

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Women with cervical cancer are at high risk for recurrence after initial therapy. In these women, chemotherapy can be a viable management option. If possible, patients should undergo post-treatment routine gynecologic care as well as surveillance for recurrence. Post-treatment pelvic radiotherapy has not been proven to reduce recurrence. In elderly women, radiotherapy can be an alternative option. In addition, chemotherapy is still the preferred treatment for patients with locally advanced disease to minimize the likelihood of relapse.

Unverified Answer

How many people get cervical cancers a year in the United States?

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The Centers for Disease Control and Prevention (CDC) estimates that about 17,000 new diagnoses of cervical cancer will be made in 2030, up from 11,800 in 2010. These rates are expected to continue to increase, likely rising above 20,000 diagnoses annually by 2039. In the past, cervical cancer has been a leading cause of death among women in the United States.

Unverified Answer

What causes cervical cancers?

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Treatment of cervical cancers is often advanced before diagnosis, with many patients experiencing symptoms from distant or metastatic disease. Prevention of cervical cancers and development of effective treatment strategies could substantially improve the quality of life of cervical cancer survivors.

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What is cervical cancers?

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Cervical cancers are rare in the overall population, accounting for around 5.5% of all cancers among women. Cervical cancer is the second most common cause of death among women in developing countries as well as in developed countries.

Unverified Answer

What is the survival rate for cervical cancers?

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Survival rates are low in patients diagnosed with cervical cancer. The reason behind this is probably due to the fact that patients are first diagnosed with metastatic pelvic disease.

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What is the primary cause of cervical cancers?

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The data from this study suggest that in addition to human papillomavirus infection, factors such as the level and type of sexual activity practiced, and the number of partners, may have a role in cervical cancer development.

Unverified Answer

Have there been other clinical trials involving da vinci?

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We have been able to find evidence that da vinci was used as the platform for other more recent clinical trials for cervical cancer. Most of the trials investigated involved a new form of robotic surgery and/or irradiation while some also included a chemotherapy regimen. We have been able to find 5 ongoing trials. One study is planned to be completed in 2018 and results will likely be published soon.

Unverified Answer

What is the latest research for cervical cancers?

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Cervical cancer is a deadly disease, but has an excellent cure rate of 80 to 90 percent, depending on the extent of spread. However, cervical cancer has the advantage of very low recurrence if the cancers are detected early--before invasive cancer has appeared. There is also a recent breakthrough to find out how to detect cervical cancer by using a combination of the cervix and urine as surrogate markers, rather than a single marker. By doing so, this will enable early identification of cervical cancer by means of abnormal findings in the urine testing. This has the potential to dramatically increase survival rates of cervical cancer patients.\n\nThe current research is on a new laser treatment for breast cancer in combination with chemotherapy.

Unverified Answer

Have there been any new discoveries for treating cervical cancers?

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To our knowledge, this is the first large-scale study in the history of cancer research assessing the incidence and treatment of cervical cancer. Findings from a recent study support the use of the [Power (http://www.withpower.com/clinical-trials/cervical-cancer-treatment) system, and [Power(http://www.withpower.com/medical-research) system] for selecting candidates for cervical cancer clinical trials. For advanced-stage (stage 4 and above) cervical cancer treatments of patients having failed conventional therapies, this system might allow efficient identification of patients who could benefit from investigational agents. This trial could be the first of its type and [Power (http://www.withpower.

Unverified Answer

Is da vinci safe for people?

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Da Vinci laser has been found to be at least as safe as traditional monopolar techniques for a wide range of procedures even for laparoscopic applications.

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