Laparoscopic Approach to Cervical Cancer

Completed · Not applicable

Conditions studied: Cervical Cancer

In brief

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.

Key facts

Study ID

NCT00614211

Run by

Queensland Centre for Gynaecological Cancer

People needed

636

Starts

2008-01-01

Expected to finish

2022-03-01

Last updated by the study team

2023-04-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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 1.
• 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

You may not qualify if…

• 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

Where it is running

• Greater Baltimore Medical Centre — Baltimore, Maryland, United States
• Women's Cancer Centre Nevada — Las Vegas, Nevada, United States
• St Luke's - Roosevelt Hospital Center — New York, New York, United States
• Peggy and Charles Stephenson Oklahoma Cancer Center — Oklahoma City, Oklahoma, United States
• M.D. Anderson Cancer Center — Houston, Texas, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Misericordia Hospital — Córdoba, Argentina
• The Wesley Hospital — Auchenflower, Queensland, Australia
• Greenslopes Private Hospital — Greenslopes, Queensland, Australia
• Royal Brisbane and Women's Hospital — Herston, Queensland, Australia
• Mater Health Services — South Brisbane, Queensland, Australia
• The Townsville Hospital — Townsville, Queensland, Australia
• Saint John of God — Subiaco, Western Australia, Australia
• Erastus Gaertner Hospital — Curitiba, Paraná, Brazil
• Barretos Cancer Hospital — Barretos, São Paulo, Brazil
• Instituto Brasileiro de Controlle do Cancer — Brás, São Paulo, Brazil
• Albert Einstein Hospital — Morumbi, São Paulo, Brazil
• University Hospital Pleven Center of Oncology Gynaecology — Pleven, Bulgaria
• Princess Margaret Hospital — Toronto, Ontario, Canada
• The First Affilated Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China
• The First Affliated Hospital of Wenzhou Medical College — Wenzhou, Zhejiang, China
• Institito De Cancerologia Clinica Las Americas — Antioquia, Medellin, Colombia
• Alessandro Manzoni Hospital — Lecco, Milan, Italy
• San Gerardo Hospital — Monza, Milan, Italy

Full record on ClinicalTrials.gov

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