KCT0008661
Not yet recruiting
未知
A Phase III Randomized Clinical Trial of Laparoscopic or Robotic RH using cancer cell spillage minimizing techniques vs Abdominal RH in Patients with Early-Stage Cervical Cancer
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Asan Medical Center
- Enrollment
- 452
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Patients aged 20\-80 years
- •2\) Histologically confirmed adenocarcinoma, squamous cell carcinoma, or adenosquamous cell carcinoma of the cervix
- •3\) Patients who qualify for 2018 FIGO IA2 or IB1\-2
- •4\) Patients undergoing type II or III radical hysterectomy (Piver Classification)
- •5\) Patients with adequate bone marrow, kidney and liver function
- •? WBC \= 3,000/mm3
- •? Platelets \= 100,000/mm3
- •? Creatinine \= 2\.0 mg/dL
- •? Bilirubin \= 1\.5 x institutional upper limit normal
- •? SGOT, SGPT, and ALP \= 3 x institutional upper limit normal
Exclusion Criteria
- •1\) Any histological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous cell carcinoma of the cervix
- •2\) Tumor size greater than 4 cm on imaging examination
- •3\) FIGO stage II\-IV
- •4\) Patients with a history of pelvic or abdominal radiation therapy
- •5\) Patients with evidence of metastatic disease on preoperative imaging, enlarged pelvic or aortic lymph nodes \> 1\.5 cm; or histologically positive lymph nodes
- •6\) If you are unable to determine whether to consent yourself
- •7\) Patients with serious underlying diseases or complications
- •8\) Women who are pregnant or lactating
- •9\) Neoadjuvant chemotherapy or preoperative radiation therapy
- •10\) Patients who have had cancer other than non\-melanoma skin cancer, cervical intraepithelial tumor, and superficial cancer of the stomach and bladder within 5 years or have received cancer treatment
Outcomes
Primary Outcomes
Not specified
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