Study Results
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Basic Information
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COMPLETED
NA
636 participants
INTERVENTIONAL
2008-01-31
2022-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Total Abdominal Radical Hysterectomy
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.
2
Total Laparoscopic or Robotic Radical Hysterectomy
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Queensland Centre for Gynaecological Cancer
OTHER_GOV
Responsible Party
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Principal Investigators
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Pedro Ramirez, M.D.
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Andreas Obermair, MD
Role: STUDY_CHAIR
Queensland Centre for Gynecological Cancer
Michael Frumovitz, M.D.
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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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
Catholic University of the Sacred Heart
Milan, Rome, Italy
European Institute of Oncology
Milan, , Italy
Instituto Nacional de Cencerologia
Tlalpan, Mexico City, Mexico
Instituto Nacional de Enfermedades Neoplasicas
Lima, Surquillo, Peru
Gyneco-Oncologico Hospital HIMA
Caguas, San Pablo, Puerto Rico
Korea Cancer Hospital
Goyang-si, Seoul, South Korea
Seoul National University - Department of Obstetrics and Gynecology
Ihwa-dong, Seoul, South Korea
ASAN Medical Center
Seoul, , South Korea
Countries
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References
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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.
Ramirez PT, Robledo KP, Frumovitz M, Pareja R, Ribeiro R, Lopez A, Yan X, Isla D, Moretti R, Bernardini MQ, Gebski V, Asher R, Behan V, Coleman RL, Obermair A. LACC Trial: Final Analysis on Overall Survival Comparing Open Versus Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer. J Clin Oncol. 2024 Aug 10;42(23):2741-2746. doi: 10.1200/JCO.23.02335. Epub 2024 May 29.
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.
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.
Related Links
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QCGC Research
Cancer Treatment and Research Centre
Other Identifiers
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LACC001
Identifier Type: -
Identifier Source: org_study_id
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