Cervical Cancer study: Da Vinci
Official title A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer
ClinicalTrials.gov ID: NCT04831580
What this study is testing
- What it's testing
- The trial aims to see if survival differs between patients who have robotic assisted laparoscopy and those who have open hysterectomy with lymph node assessment.
- Who it's for
- Women with early‑stage cervical cancer who are eligible for either robotic or open surgery.
- What's involved
- Participants will be randomly assigned to receive either robotic assisted laparoscopy or open hysterectomy, and will have lymph nodes examined as part of the surgery.
- Time commitment
- The study lasts until the final follow‑up after surgery, with visits for pre‑ and post‑operative care and routine follow‑up appointments.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy...
- Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or...
- Patient must have uterine size \<12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator.
- pelvic MRI must demonstrate a maximal tumor size of 2 cm or less AND
- less than 50% stromal invasion on MRI if tumor present or less than 10 mm of stromal invasion if an excisional (cold knife or LEEP) has been...
You likely can't join if
- Patients with any tumor histology other than those listed above, specifically excluding the following histologies: neuroendocrine, other...
- Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).
- Patient with inability to receive an MRI.
- Patients with a tumor size greater than 4cm or on MRI confirmed prior to randomization are excluded.
- Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).
- Patients with a history of prior pelvic or abdominal radiotherapy.
See the full eligibility criteria
- 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 have uterine size \<12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator.
- pelvic MRI must demonstrate a maximal tumor size of 2 cm or less AND
- less than 50% stromal invasion on MRI if tumor present or less than 10 mm of stromal invasion if an excisional (cold knife or LEEP) has been performed.
- 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.
- Patients with any tumor histology other than those listed above, specifically excluding the following histologies: neuroendocrine, other adenocarcinoma (gastric type, endometrioid, clear cell, serous, signet ring...
- Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).
- Patient with inability to receive an MRI.
- Patients with a tumor size greater than 4cm or on MRI confirmed prior to randomization are excluded. Patients with definite evidence of vaginal/parametrial involvement on MRI are excluded
- Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).
- Patients with a history of prior pelvic or abdominal radiotherapy.
- Patients with a prior malignancy \< 5 years from enrollment with the exception of non-melanoma skin cancer.
- Patients who are unable to withstand prolonged lithotomy or steep trendelenberg.
- Patient compliance and geographic proximity that do not allow adequate follow-up.
- Patients with poorly controlled HIV with CD4 counts \<500.
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Encinitas, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Palo Alto, California, United States
- San Diego, California, United States
- Upland, California, United States
- Vista, California, United States
- Hartford, Connecticut, United States
- Manchester, Connecticut, United States
- New Britain, Connecticut, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Augusta, Georgia, United States
- Lexington, Kentucky, United States
- New Orleans, Louisiana, United States
- Shreveport, Louisiana, United States
- Scarborough, Maine, United States
+ 68 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Encinitas, California, United States; Irvine, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Newport Beach, California, United States and 82 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.