Clinical Trial Title A Randomized Controlled Trial of Robotic versus Open Radical Hysterectomy for Cervical Cancer (ROCC trial)
Trial Status Open to Enrollment
Start Date 04/18/2022
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Cervical Cancer
Description 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.
Eligibility Criteria

Inclusion 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 be suitable surgical candidate with preoperative assessmentssuch as labs and EKG performed per institutional standard.
  • Patient must have ECOG performance status 0-1.

Exclusion Criteria

  • Patient with inability to receive an MRI.
  • 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.
  • Patient compliance and geographic proximity that do not allow adequate follow-up.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number Central IRB
Notes A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer - Full Text View - ClinicalTrials.gov
Principal Investigator Gina Westhoff, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org