Laparoscopic Approach to Cervical Cancer (LACC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 23, 2014
Last verified: September 2014
  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
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, see Learn About Clinical Studies.

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 34 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: September 23, 2014
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
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014