A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

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Trial ID: NCT04831580

Purpose

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

Official Title

A Randomized Controlled Trial of Robotic Versus Open Radical Hysterectomy for Cervical Cancer (ROCC)

Stanford Investigator(s)

Amer Karam
Amer Karam

Clinical Professor, Obstetrics & Gynecology - Gynecologic Oncology

Eligibility


Inclusion Criteria:

   1. Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS),
   squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell)

   2. Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive
   parametrial, vaginal, nodal or distant metastases on exam or imaging. Patients with
   tumor size less than or equal to 4 cm confirmed on MRI prior to randomization are
   eligible.

   3. Patient must have uterine size <12 cm AND felt to be appropriate for vaginal delivery
   of the specimen per investigator.

   4. Patient must be suitable surgical candidate with preoperative assessments such as labs
   and EKG performed per institutional standard.

   5. Patient must be age 18 years or older.

   6. Patient must have ECOG performance status 0-1.

   7. Patient must have a negative urine pregnancy test within 30 days of surgery in
   pre-menopausal women.

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

Exclusion Criteria:

   1. 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, minimal deviation)

   2. Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).

   3. Patient with inability to receive an MRI.

   4. 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; if MRI findings are not definitive, then clinical examination must
   also not reveal parametrial or vaginal extension).

   5. Patients with evidence of metastatic disease (imaging or histologically positive lymph
   nodes).

   6. Patients with a history of prior pelvic or abdominal radiotherapy.

   7. Patients with a prior malignancy < 5 years from enrollment with the exception of
   non-melanoma skin cancer.

   8. Patients who are unable to withstand prolonged lithotomy or steep trendelenberg.

   9. Patient compliance and geographic proximity that do not allow adequate follow-up.

10. Patients with poorly controlled HIV with CD4 counts <500.

Intervention(s):

device: da Vinci

other: open surgery

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Feriel Buchholz
650-721-4090

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