Laparoscopic Approach to Cervical Cancer (LACC)

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ClinicalTrials.gov Identifier: NCT00614211

Recruitment Status : Completed

First Posted : February 13, 2008

Last Update Posted : April 18, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

M.D. Anderson Cancer Center

Information provided by (Responsible Party):

Queensland Centre for Gynaecological Cancer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cervical Cancer	Procedure: Total Abdominal Radical Hysterectomy Procedure: Total Laparoscopic or Robotic Radical Hysterectomy	Not Applicable

Show detailed description

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	636 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy Versus Abdominal Radical Hysterectomy in Patients With Early Stage Cervical Cancer
Actual Study Start Date :	January 2008
Actual Primary Completion Date :	March 2022
Actual Study Completion Date :	March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer Hysterectomy

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 Total Abdominal Radical Hysterectomy	Procedure: Total Abdominal Radical Hysterectomy In a radical hysterectomy the uterus, the upper one to two centimetres of the vagina and the soft tissues around the cervix are excised. Other Names: TARH Open radical hysterectomy
Experimental: 2 Total Laparoscopic or Robotic Radical Hysterectomy	Procedure: Total Laparoscopic or Robotic Radical Hysterectomy In a radical hysterectomy the uterus, the upper one to two centimetres of the vagina and the soft tissues around the cervix are excised. Other Names: TLRH TRRH Keyhole radical hysterectomy

Outcome Measures

Primary Outcome Measures :

Disease free survival [ Time Frame: 5 years from surgery ]
Compare treatment equivalence

Secondary Outcome Measures :

Patterns of recurrence [ Time Frame: 5 years from surgery ]
date and localization of 1st recurrence as confirmed histologically - Compare patterns between groups
Costs [ Time Frame: 6 months from surgery ]
Compare costs between groups
Quality of life Questionnaires [ Time Frame: 6 months from surgery ]
Compare QoL between groups
Pelvic Floor Distress Inventory Questionnaire [ Time Frame: 5 years from surgery ]
Compare PFDI between groups
Overall survival [ Time Frame: 5 years from surgery ]
Compare between groups
Feasibility of sentinel lymph node biopsy [ Time Frame: Intra-operatively ]
Compare between groups
Intra-operative, peri-operative, post-operative and long term treatment related morbidity [ Time Frame: 6 months from surgery ]
Compare these between groups

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00614211

Locations

Show 33 study locations

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United States, Maryland
Greater Baltimore Medical Centre
Baltimore, Maryland, United States, 21204
United States, Nevada
Women's Cancer Centre Nevada
Las Vegas, Nevada, United States, 89169
United States, New York
St Luke's - Roosevelt Hospital Center
New York, New York, United States, 10019
United States, Oklahoma
Peggy and Charles Stephenson Oklahoma Cancer Center
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77230-1439
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Argentina
Misericordia Hospital
Cordoba, Argentina
Australia, Queensland
The Wesley Hospital
Auchenflower, Queensland, Australia, 4066
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
Mater Health Services
South Brisbane, Queensland, Australia, 4101
The Townsville Hospital
Townsville, Queensland, Australia, 4814
Australia, Western Australia
Saint John of God
Subiaco, Western Australia, Australia
Brazil
Erastus Gaertner Hospital
Curitiba, Parana, Brazil
Albert Einstein Hospital
Morumbi, San Paulo, Brazil
Instituto Brasileiro de Controlle do Cancer
Bras, Sao Paulo, Brazil
Barretos Cancer Hospital
Barretos, SP, Brazil
Bulgaria
University Hospital Pleven Center of Oncology Gynaecology
Pleven, Bulgaria, 5800
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada
China, Guangdong
The First Affilated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China, 325000
Colombia
Institito De Cancerologia Clinica Las Americas
Antioquia, Medellin, Colombia
Italy
Alessandro Manzoni Hospital
Lecco, Milan, Italy
San Gerardo Hospital
Monza, Milan, Italy
Catholic University of the Sacred Heart
Milan, Rome, Italy
European Institute of Oncology
Milan, Italy, 20141
Korea, Republic of
Korea Cancer Hospital
Goyang-si, Seoul, Korea, Republic of
Seoul National University - Department of Obstetrics and Gynecology
Ihwa-Dong, Seoul, Korea, Republic of
ASAN Medical Center
Seoul, Korea, Republic of
Mexico
Instituto Nacional de Cencerologia
Tlalpan, Mexico City, Mexico
Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, Surquillo, Peru
Puerto Rico
Gyneco-Oncologico Hospital HIMA
Caguas, Puerto Rico

Sponsors and Collaborators

Queensland Centre for Gynaecological Cancer

M.D. Anderson Cancer Center

Investigators

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Study Chair:	Pedro Ramirez, M.D.	M.D. Anderson Cancer Center
Study Chair:	Andreas Obermair, MD	Queensland Centre for Gynecological Cancer
Study Chair:	Michael Frumovitz, M.D.	M.D. Anderson Cancer Center

More Information

Additional Information:

QCGC Research This link exits the ClinicalTrials.gov site

Cancer Treatment and Research Centre This link exits the ClinicalTrials.gov site

Publications:

Obermair A, Gebski V, Frumovitz M, Soliman PT, Schmeler KM, Levenback C, Ramirez PT. A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy with abdominal radical hysterectomy in patients with early stage cervical cancer. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):584-8. doi: 10.1016/j.jmig.2008.06.013.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tanaka T, Ueda S, Miyamoto S, Hashida S, Terada S, Konishi H, Kogata Y, Taniguchi K, Komura K, Ohmichi M. Comparison of Prognosis between Minimally Invasive and Abdominal Radical Hysterectomy for Patients with Early-Stage Cervical Cancer. Curr Oncol. 2022 Mar 24;29(4):2272-2283. doi: 10.3390/curroncol29040185.

Frumovitz M, Obermair A, Coleman RL, Pareja R, Lopez A, Ribero R, Isla D, Rendon G, Bernardini MQ, Buda A, Moretti-Marquez R, Zevallos A, Vieira MA, Zhu T, Land RP, Nicklin J, Asher R, Robledo KP, Gebski V, Ramirez PT. Quality of life in patients with cervical cancer after open versus minimally invasive radical hysterectomy (LACC): a secondary outcome of a multicentre, randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2020 Jun;21(6):851-860. doi: 10.1016/S1470-2045(20)30081-4. Erratum In: Lancet Oncol. 2020 Jul;21(7):e341.

Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31.

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Responsible Party:	Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier:	NCT00614211
Other Study ID Numbers:	LACC001
First Posted:	February 13, 2008 Key Record Dates
Last Update Posted:	April 18, 2023
Last Verified:	April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Queensland Centre for Gynaecological Cancer:


Cervix Cervical Cancer Carcinoma Radical hysterectomy Hysterectomy Laparoscopy Laparoscopic Robotic	Squamous Cell Adenosquamous Adenocarcinoma Lymphatic Mapping IOLM SPECT Sentinel Node Uterine cervix

Additional relevant MeSH terms:

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Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases	Uterine Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases

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