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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

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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



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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


  Show 33 Study Locations
Sponsors and Collaborators
Queensland Centre for Gynaecological Cancer
M.D. Anderson Cancer Center
Investigators
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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):
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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:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female