A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy Versus Abdominal Radical Hysterectomy in Patients With Early Stage Cervical Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 636
- Locations
- 45
- Primary Endpoint
- Disease free survival
Study Overview
Brief Summary
The goal of this clinical research study is to compare the long-term outcomes of different surgical methods for the treatment of cervical cancer. The long-term outcome of a total abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study, the laparoscopy will be done with or without robotic technology.
Detailed Description
Primary Objective:
To compare disease-free survival amongst patients who undergo a total laparoscopic (TLRH) or robotic radical hysterectomy (TRRH) verses those who undergo a total abdominal radical hysterectomy (TARH) for early stage cervical cancer.
Secondary Objectives:
- Compare patterns of recurrence between arms.
- Compare treatment-associated morbidity within 6 months from surgery.
- Compare the cost effectiveness of TLRH/TRRH versus TARH
- Compare the impact on Quality of Life (QOL) between arms.
- Assess pelvic floor function
- Compare overall survival between arms
- Determine the feasibility of sentinel lymph node biopsy in this group of patients
RATIONALE FOR STUDY DESIGN Total abdominal radical hysterectomy (TARH) and pelvic lymph node dissection (± aortic lymph node dissection ± postoperative [chemo-] radiotherapy) is the current standard treatment for early cervical cancer. While this is an accepted effective treatment, a laparotomy is highly invasive, visibly scarring and is associated with tissue trauma, blood loss and a significant risk of wound and infectious adverse events . Additionally, radical hysterectomy by laparotomy is associated with an average hospital stay of approximately 5 to 7 days and an average recovery period (from surgery) of 5 to 6 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
- •Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), stage IA2, or stage IB1 disease
- •Patients undergoing either a Type II or III radical hysterectomy (Piver Classification)
- •Patients with adequate bone marrow, renal and hepatic function:
- •ECOG Performance Status of 0 or
- •Patient must be suitable candidates for surgery.
- •Patients who have signed an approved Informed Consent
- •Patients with a prior malignancy allowed if > 5 years ago with no current evidence of disease
- •Females, aged 18 years or older
- •Negative serum pregnancy test within <30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause
Exclusion Criteria
- •Any histology other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
- •Tumor size greater than 4 cm;
- •FIGO stage II-IV;
- •Patients with a history of pelvic or abdominal radiotherapy;
- •Patients who are pregnant;
- •Patients with contraindications to surgery;
- •Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes
- •Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
- •Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
- •Patient compliance and geographic proximity that do not allow adequate follow-up
Outcomes
Primary Outcomes
Disease free survival
Time Frame: 5 years from surgery
Compare treatment equivalence
Secondary Outcomes
- Costs(6 months from surgery)
- Quality of life Questionnaires(6 months from surgery)
- Overall survival(5 years from surgery)
- Patterns of recurrence(5 years from surgery)
- Pelvic Floor Distress Inventory Questionnaire(5 years from surgery)
- Intra-operative, peri-operative, post-operative and long term treatment related morbidity(6 months from surgery)
- Feasibility of sentinel lymph node biopsy(Intra-operatively)