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Laparoscopic Approach to Cervical Cancer (LACC)
This study is currently recruiting participants.
Verified by Queensland Centre for Gynaecological Cancer, October 2008
Sponsors and Collaborators: Queensland Centre for Gynaecological Cancer
M.D. Anderson Cancer Center
Information provided by: Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier: NCT00614211
  Purpose

The primary objective of this study is to assess disease-free survival at 4.5 years postoperatively amongst patients who undergo a Total Laparoscopic (TLRH) or Total Robotic Radical Hysterectomy versus those who undergo a Total Abdominal Radical Hysterectomy for the treatment of early stage cervical cancer.


Condition Intervention Phase
Cervical Cancer
Procedure: Total Abdominal Radical Hysterectomy
Procedure: Total Laparoscopic or Robotic Radical Hysterectomy
Phase III

MedlinePlus related topics: Cancer Hysterectomy
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
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

Further study details as provided by Queensland Centre for Gynaecological Cancer:

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 4.5 years from surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patterns of recurrence [ Time Frame: 4.5 years from surgery ] [ Designated as safety issue: No ]
  • Intra-operative, peri-operative, post-operative and long term treatment related morbidity [ Time Frame: 12 months from surgery ] [ Designated as safety issue: Yes ]
  • Costs [ Time Frame: 6 months from surgery ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6 months from surgery ] [ Designated as safety issue: No ]
  • Pelvic Floor Distress Inventory [ Time Frame: 4.5 years from surgery ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 4.5 years from surgery ] [ Designated as safety issue: No ]
  • Feasibility of sentinel lymph node biopsy [ Time Frame: Intra-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 740
Study Start Date: January 2008
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
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.
2: Experimental
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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 10 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;
  • Uterine size larger than 12 cm;
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614211

Contacts
Contact: Trudi Cattley, BAppSc +61 7 3636 0447 Trudi_Cattley@health.qld.gov.au
Contact: Pedro Ramirez peramire@mdanderson.org

Locations
United States, Texas
M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States
Contact: Pedro Ramirez, M.D.         peramire@mdanderson.org    
Contact: Maria Jung         mjung@mdanderson.org    
Principal Investigator: Pedro Ramirez, M.D.            
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Contact: Andreas Obermair, MD FRANZCOG CGO     +61 7 3636 8501     andreas_obermair@health.qld.gov.au    
Contact: Trudi Cattley, BAppSc     +61 7 3636 1722     Trudi_Cattley@health.qld.gov.au    
Principal Investigator: Andreas Obermair, MD FRANZCOG COG            
Sub-Investigator: Russell Land            
Greenslopes Private Hospital Recruiting
Greenslopes, Queensland, Australia, 4120
Contact: Trudi Cattley     07 3636 0447     Trudi_Cattley@health.qld.gov.au    
Principal Investigator: Andreas Obermair            
Sub-Investigator: Russell Land            
The Wesley Hospital Recruiting
Auchenflower, Queensland, Australia, 4066
Contact: Trudi Cattley     07 3636 0447     Trudi_Cattley@health.qld.gov.au    
Principal Investigator: Russell Land            
Sponsors and Collaborators
Queensland Centre for Gynaecological Cancer
M.D. Anderson Cancer Center
Investigators
Study Chair: Pedro Ramirez, M.D. M.D. Anderson Cancer Center
Study Chair: Andreas Obermair, MD FRANZCOG CGO Queensland Centre for Gynecological Cancer
Study Chair: Michael Frumovitz, M.D. M.D. Anderson Cancer Center
  More Information

Publications:
Responsible Party: M.D. Anderson Cancer Center ( Associate Professor Pedro Ramirez )
Study ID Numbers: LACC001
Study First Received: January 31, 2008
Last Updated: October 1, 2008
ClinicalTrials.gov Identifier: NCT00614211  
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration;   Australia: Human Research Ethics Committee;   Australia: National Health and Medical Research Council;   United States: Institutional Review Board

Keywords provided by Queensland Centre for Gynaecological Cancer:
Cervix
Cervical
Cancer
Carcinoma
Radical hysterectomy
Hysterectomy
Laparoscopy
Laparoscopic
Robotic
Adenocarcinoma
Lymphatic Mapping
IOLM
Sentinel Node
Uterine cervix

Study placed in the following topic categories:
Adenocarcinoma
Carcinoma

ClinicalTrials.gov processed this record on January 14, 2009