Laparoscopic Approach to Cervical Cancer
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Cervix, Cervical, Cancer, Carcinoma, Radical hysterectomy, Hysterectomy, Laparoscopy, Laparoscopic, Robotic, Squamous Cell, Adenosquamous, Adenocarcinoma, Lymphatic Mapping, IOLM, SPECT, Sentinel Node, Uterine cervix
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Total Abdominal Radical Hysterectomy Type: Procedure
Name: Total Laparoscopic or Robotic Radical Hysterectomy Type: Procedure
Overall Status
Recruiting
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.

Laparoscopic techniques have been demonstrated to be feasible and safe with previous retrospective studies on TLH 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 hysterectomy compared to patients who underwent a TAH . Retrospective data suggest that the recurrence rate and patterns of recurrence are similar in patients who had a laparoscopic 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). However, there are currently no prospective studies available which directly compare TLRH against the standard treatment of TARH in regards to disease-free or overall survival.

The proposed clinical trial will be biphasic. The primary outcome variable in stage 1 will be feasibility of recruitment as determined by overall trial recruitment. Following completion of Stage 1, the data of this study will become the basis for assessing recurrence and disease-free survival in the Stage 2 design.

RATIONALE FOR THE QUALITY OF LIFE Retrospective studies suggest equivalency between the laparoscopic and open approaches to radical hysterectomy in regards to surgical specimens obtained and likely disease-free and overall survivals . Thus, quality of life could be seen as one of the most significant factors in recommending one approach over the other and therefore an extremely important endpoint for this protocol. In the GOG LAP-2 protocol , a trial evaluating a comparison between hysterectomy by laparotomy or laparoscopy, the investigators found equivalency adequacy of the two surgical approaches however a significant difference in short term quality of life favoring laparoscopy. As expected, patients who underwent laparoscopy had a faster return to baseline functioning compared with those patients who had undergone laparotomy which translated into improved short-term quality of life. By 6 months, however, patients in both cohorts were reporting equivalent quality of life parameters. Quality of life surveys employed with this Phase III clinical trial will encompass important endpoints such as postoperative pain and related symptoms using the MD Anderson Symptom Assessment Index (MDSAI), as well as cancer specific Functional Assessment of Cancer Therapy (FACT-Cx) and the general 12-Item Short-Form Health Survey (SF-12).

RATIONALE FOR LYMPHATIC MAPPING Published experience with the techniques for lymphatic mapping and sentinel lymph node detection in women with cervical cancer has been very limited. To date, no single study has enrolled more than 100 patients undergoing lymphatic mapping as part of their surgical treatment for cervical cancer. In fact, the majority of studies report on less than 50 patients. In addition, this procedure has not yet been shown to be viable in a multi-institutional setting. The limitations of previously published reports are important as these techniques are associated with a significantly high learning curve with early procedures less successful than later ones. This study will provide us the opportunity to enroll large numbers of patients for validation of intraoperative lymphatic mapping in women with cervical cancer in an international, multi-institutional setting.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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 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

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
Locations
Greater Baltimore Medical Centre
Baltimore, Maryland, United States
Status: Recruiting
Contact: Amanda Fader - amandanfader@gmail.com
John Hopkins Hospital
Baltimore, Maryland, United States
Status: Not yet recruiting
Contact: Amanda Fader, MD - amandanfader@gmail.com
Women's Cancer Centre Nevada
Las Vegas, Nevada, United States
Status: Recruiting
Contact: Nick Spirtos, MD - nspirtos@wccenter.com
St Luke's - Roosevelt Hospital Center
New York, New York, United States
Status: Recruiting
Contact: Farr Nezhat, MD FACOG - 212-523-7337 - fnezhat@chpnet.org
Peggy and Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, United States
Status: Recruiting
Contact: Ingrid Block, RN, MS, CNS - 405-271-8777 - ingrid-block@ouhsc.edu
Lyndon B. Johnson - MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Julieta Palencia - jpalencia@mdanderson.org
M.D. Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Pedro Ramirez, M.D. - peramire@mdanderson.org
University of Wisconsin
Madison, Wisconsin, United States
Status: Active, not recruiting
Misericordia Hospital
Cordoba, Argentina
Status: Not yet recruiting
Contact: Fernado Larrazabal - flarrazabal@yahoo.es
The Wesley Hospital
Auchenflower, Queensland, Australia
Status: Recruiting
Contact: Vanessa Behan - +61 7 3646 4343 - Vanessa.Behan@health.qld.gov.au
Greenslopes Private Hospital
Greenslopes, Queensland, Australia
Status: Recruiting
Contact: Vanessa Behan, Bach Nursing - +61 7 3646 4343 - Vanessa.Behan@health.qld.gov.au
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Status: Recruiting
Contact: Vanessa Behan, BNursing - +61 7 3646 4343 - Vanessa.Behan@health.qld.gov.au
Mater Health Services
South Brisbane, Queensland, Australia
Status: Recruiting
Contact: Vanessa Behan - +61 7 3646 4343 - Vanessa.Behan@health.qld.gov.au
The Townsville Hospital
Townsville, Queensland, Australia
Status: Recruiting
Contact: Vanessa Behan - +61 7 3646 4343 - Vanessa.Behan@health.qld.gov.au
Saint John of God
Perth, Western Australia, Australia
Status: Not yet recruiting
Contact: Stuart Salfinger, MD - stuart.salfinger@me.com
King Edward Memorial Hospital
Subiaco, Western Australia, Australia
Status: Not yet recruiting
Contact: Yee Leung, MD - Yee.Leung@health.wa.gov.au
Erastus Gaertner Hospital
Curitiba, Parana, Brazil
Status: Recruiting
Contact: Reitan Ribeiro - reitanribeiro@hotmail.com
Albert Einstein Hospital
Morumbi, San Paulo, Brazil
Status: Recruiting
Contact: Fernanda Assir - fernanda.assir@einstein.br
Barretos Cancer Hospital
Barretos, SP, Brazil
Status: Recruiting
Contact: Jose Humberto - mdfregnani@terra.com.br
University Hospital Pleven Center of Oncology Gynaecology
Pleven, Bulgaria
Status: Recruiting
Contact: Grigor Gorchev, MD - oncogynec@yahoo.com
Princess Margaret Hospital
Toronto, Ontario, Canada
Status: Recruiting
Contact: Marcus Bernardini - marcus.bernardini@uhn.on.ca
The First Affilated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Yao Shu Zhong - yszlfy@163.com
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Status: Not yet recruiting
Contact: Tao Zhu, MD - kernor@163.com
The First Affliated Hospital of Wenzhou Medical College
Zhejiang, China
Status: Recruiting
Contact: Xiaojian Yan - yxjbetter@yahoo.com.cn
Institito De Cancerologia Clinica Las Americas
Antioquia, Medellin, Colombia
Status: Recruiting
Contact: Rene Pareja - reneparejafranco@yahoo.com
Rajiv Gandhi Cancer Institute and Research Center
New Delhi, Delhi, India
Status: Recruiting
Contact: Rupinder Sekhon - rupysekhon@hotmail.com
Alessandro Manzoni Hospital
Lecco, Milan, Italy
Status: Recruiting
Contact: Antonio Pellegrino - dr.pellierino@libero.it
San Gerardo Hospital
Monza, Milan, Italy
Status: Recruiting
Contact: Alessandro Buda - alessandro.buda@fastwebnet.it
Catholic University of the Sacred Heart
Milan, Rome, Italy
Status: Not yet recruiting
Contact: Francesca Capobianco - francesca.capobianco@rm.unicatt.it
European Institute of Oncology
Milan, Italy
Status: Recruiting
Contact: Sara Boveri - sara.boveri@ieo.it
CHA Bundang Medical Centre, CHA University
Bundang, Seoul, Korea, Republic of
Status: Withdrawn
Gangnam CHA Medical Centre
Gangnam-Gu, Seoul, Korea, Republic of
Status: Withdrawn
Samsung Medical Centre
Gangnam-Gu, Seoul, Korea, Republic of
Status: Withdrawn
Korea Cancer Hospital
Mok-dong, Seoul, Korea, Republic of
Status: Recruiting
Contact: Sang-Young Ryu - ryu@kcch.re.kr
ASAN Medical Centre
Songpa-Gu, Seoul, Korea, Republic of
Status: Recruiting
Contact: Joo-Hyun Nam, MD - jhnam@amc.seoul.kr
Seoul National University - Department of Obstetrics and Gynecology
Yeongeon-dong, Seoul, Korea, Republic of
Status: Recruiting
Contact: Jae-Weon Kim, MD - kjwksh@snu.ac.kr
Instituto Nacional de Cencerologia
Tlalpan, Mexico City, Mexico
Status: Not yet recruiting
Contact: Lizeth Leon - psiclizleon_incan@outlook.com
Start Date
January 2008
Completion Date
July 2022
Sponsors
Queensland Centre for Gynaecological Cancer
Source
Queensland Centre for Gynaecological Cancer
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page