Laparoscopic Approach to Cervical Cancer (LACC)

This study is currently recruiting participants.
Verified June 2013 by Queensland Centre for Gynaecological Cancer
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier:
NCT00614211
First received: January 31, 2008
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Cervical Cancer
Procedure: Total Abdominal Radical Hysterectomy
Procedure: Total Laparoscopic or Robotic Radical Hysterectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disease free survival [ Time Frame: 5 years from surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patterns of recurrence [ Time Frame: 5 years from surgery ] [ Designated as safety issue: No ]
  • 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: 5 years from surgery ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 5 years from surgery ] [ Designated as safety issue: No ]
  • Feasibility of sentinel lymph node biopsy [ Time Frame: Intra-operatively ] [ Designated as safety issue: No ]
  • Intra-operative, peri-operative, post-operative and long term treatment related morbidity [ Time Frame: 6 months from surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 740
Study Start Date: January 2008
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  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 <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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614211

Contacts
Contact: Vanessa Behan, BNursing +61 7 3646 4343 Vanessa_Behan@health.qld.gov.au
Contact: Pedro Ramirez peramire@mdanderson.org

  Show 33 Study Locations
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 Queensland Centre for Gynecological Cancer
Study Chair: Michael Frumovitz, M.D. M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier: NCT00614211     History of Changes
Other Study ID Numbers: LACC001
Study First Received: January 31, 2008
Last Updated: June 5, 2013
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:
Uterine cervix
Cervix
Cervical
Cancer
Carcinoma
Radical hysterectomy
Hysterectomy
Laparoscopy
Laparoscopic
Robotic
Squamous Cell
Adenosquamous
Adenocarcinoma
Lymphatic Mapping
IOLM
SPECT
Sentinel Node

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 23, 2014