None listed
Conditions
Brief summary
We are conducting a Phase III Randomized Clinical Trial Comparing Laparoscopic or Robotic Radical Hysterectomy versus Abdominal Radical Hysterectomy in Patients with Early Stage Cervical Cancer. The primary objective of this study is to compare disease-free survival amongst patients who undergo a total laparoscopic or robotic radical hysterectomy (TLRH/TRRH) versus those who undergo a total abdominal radical hysterectomy (TARH) for early stage cervical cancer. Method 1 is the standard approach worldwide and consists of a laparotomy where the abdomen is opened through a vertical incision or a lower transverse incision and the uterus, the upper one to two centimetres of the vagina and soft tissue around the cervix are removed. Method 2 is a relatively new method where the operation is performed laparoscopically. The rationale for the study design is that 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. Laparoscopic/Robotic techniques have been demonstrated to be feasible and safe with previous retrospective studies on Total Laparoscopic/Robotic Hysterectomies showing encouraging results. In a number of retrospective and prospective, non-controlled series the incidence of treatment-related morbidity was less in patients who had a laparoscopic/robotic hysterectomy compared to patients who underwent a Total Abdominal Hysterectomy. Retrospective data suggest that the recurrence rate and patterns of recurrence are similar in patients who had a laparoscopic/robotic or an open approach. Treatment recommendations ideally are based on prospective, randomized trials comparing the current standard technique (TARH) with the proposed better technique (TLRH/TRRH). However, there are currently no prospective studies available which directly compare Total Laparoscopic/Robotic Radical Hysterectomy against the standard treatment of Total Abdominal Radical Hysterectomy in regards to disease-free or overall survival.
Interventions
The surgery is a Radical Hysterectomy performed laparoscopically or robotically for the treatment of cervical cancer. This involves the removal of the uterus, the upper one to two centimetres of the vagina and the soft tissues around the cervix.The surgical procedure takes 2-4 hours.
Sponsors
M.D Anderson Cancer Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix; 2. Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA1 (with lymph vascular space invasion), IA2, or IB1 disease; 3. Patients undergoing either a Type II or III radical hysterectomy (Piver Classification) 4. Patients with adequate bone marrow, renal and hepatic function: 4.1 White Blood Cells (WBC) > 3,000 cells/mcl 4.2 Platelets >100,000/mcl 4.3 Creatinine <2.0 mg/dL (Non-Isotope dilution mass spectrometry (non – IDMS)) 4.4 Bilirubin <1.5 x normal and Serum Glutamic Oxaloacetic Transaminase (SGOT) or Serum Glutamic Pyruvic Transaminase (SGPT) <3 x normal 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6. Patient must be suitable candidates for surgery; 7. Patients who have signed an approved Informed Consent; 8. Patients with a prior malignancy allowed if > 5 years previous with no current evidence of disease; 9. Females, aged 18 years or older. 10. Negative serum pregnancy test within 30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause
Exclusion criteria
1. Any histological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix; 2. Tumor size greater than 4 cm; 3. FIGO stage II-IV; 4. Patients with a history of pelvic or abdominal radiotherapy; 5. Patients who are pregnant; 6. Patients with contraindications to surgery; 7. Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes 8. Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator); 9. Patients unable to withstand prolonged lithotomy and steep Trendelenburg position 10. Patient compliance and geographic proximity that do not allow adequate follow-up. 11. Patients who agree to intra-operative lymphatic mapping (IOLM) must not have: - Known allergies to triphenylmethane compounds. - History of retroperitoneal surgery. - History of pelvic irradiation. - Cold knife or loop electrosurgical excision procedure (LEEP) cone biopsy within 4 wks of enrollment.
Outcome results
None listed