Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laparoscopic Approach to Cervical Cancer (LACC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00614211
Recruitment Status : Active, not recruiting
First Posted : February 13, 2008
Last Update Posted : August 29, 2019
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Queensland Centre for Gynaecological Cancer

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

Layout table for study information
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
Study Start Date : January 2008
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 5 years from surgery ]
    Compare treatment equivalence


Secondary Outcome Measures :
  1. Patterns of recurrence [ Time Frame: 5 years from surgery ]
    date and localization of 1st recurrence as confirmed histologically - Compare patterns between groups

  2. Costs [ Time Frame: 6 months from surgery ]
    Compare costs between groups

  3. Quality of life Questionnaires [ Time Frame: 6 months from surgery ]
    Compare QoL between groups

  4. Pelvic Floor Distress Inventory Questionnaire [ Time Frame: 5 years from surgery ]
    Compare PFDI between groups

  5. Overall survival [ Time Frame: 5 years from surgery ]
    Compare between groups

  6. Feasibility of sentinel lymph node biopsy [ Time Frame: Intra-operatively ]
    Compare between groups

  7. Intra-operative, peri-operative, post-operative and long term treatment related morbidity [ Time Frame: 6 months from surgery ]
    Compare these between groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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


  Hide Study Locations
Locations
Layout table for location information
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
Layout table for investigator information
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

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier: NCT00614211     History of Changes
Other Study ID Numbers: LACC001
First Posted: February 13, 2008    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
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:
Layout table for MeSH terms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female