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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

Tracking Information
First Submitted Date  ICMJE January 31, 2008
First Posted Date  ICMJE February 13, 2008
Last Update Posted Date August 29, 2019
Study Start Date  ICMJE January 2008
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
Disease free survival [ Time Frame: 5 years from surgery ]
Compare treatment equivalence
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
Disease free survival [ Time Frame: 4.5 years from surgery ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
  • Patterns of recurrence [ Time Frame: 5 years from surgery ]
    date and localization of 1st recurrence as confirmed histologically - Compare patterns between groups
  • Costs [ Time Frame: 6 months from surgery ]
    Compare costs between groups
  • Quality of life Questionnaires [ Time Frame: 6 months from surgery ]
    Compare QoL between groups
  • Pelvic Floor Distress Inventory Questionnaire [ Time Frame: 5 years from surgery ]
    Compare PFDI between groups
  • Overall survival [ Time Frame: 5 years from surgery ]
    Compare between groups
  • Feasibility of sentinel lymph node biopsy [ Time Frame: Intra-operatively ]
    Compare between groups
  • Intra-operative, peri-operative, post-operative and long term treatment related morbidity [ Time Frame: 6 months from surgery ]
    Compare these between groups
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2008)
  • Patterns of recurrence [ Time Frame: 4.5 years from surgery ]
  • Intra-operative, peri-operative, post-operative and long term treatment related morbidity [ Time Frame: 12 months from surgery ]
  • Costs [ Time Frame: 6 months from surgery ]
  • Quality of life [ Time Frame: 6 months from surgery ]
  • Pelvic Floor Distress Inventory [ Time Frame: 4.5 years from surgery ]
  • Overall survival [ Time Frame: 4.5 years from surgery ]
  • Feasibility of sentinel lymph node biopsy [ Time Frame: Intra-operatively ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laparoscopic Approach to Cervical Cancer
Official Title  ICMJE A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy Versus Abdominal Radical Hysterectomy in Patients With Early Stage Cervical 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.
Detailed Description

Primary Objective:

To compare disease-free survival amongst patients who undergo a total laparoscopic (TLRH) or robotic radical hysterectomy (TRRH) verses those who undergo a total abdominal radical hysterectomy (TARH) for early stage cervical cancer.

Secondary Objectives:

  • Compare patterns of recurrence between arms.
  • Compare treatment-associated morbidity within 6 months from surgery.
  • Compare the cost effectiveness of TLRH/TRRH versus TARH
  • Compare the impact on Quality of Life (QOL) between arms.
  • Assess pelvic floor function
  • Compare overall survival between arms
  • Determine the feasibility of sentinel lymph node biopsy in this group of patients

RATIONALE FOR STUDY DESIGN Total abdominal radical hysterectomy (TARH) and pelvic lymph node dissection (± aortic lymph node dissection ± postoperative [chemo-] radiotherapy) is the current standard treatment for early cervical cancer. While this is an accepted effective treatment, a laparotomy is highly invasive, visibly scarring and is associated with tissue trauma, blood loss and a significant risk of wound and infectious adverse events . Additionally, radical hysterectomy by laparotomy is associated with an average hospital stay of approximately 5 to 7 days and an average recovery period (from surgery) of 5 to 6 weeks.

Laparoscopic techniques have been demonstrated to be feasible and safe with previous retrospective studies on TLH showing encouraging results . In a number of retrospective and prospective, non-controlled series the incidence of treatment-related morbidity was less in patients who had a laparoscopic hysterectomy compared to patients who underwent a TAH . Retrospective data suggest that the recurrence rate and patterns of recurrence are similar in patients who had a laparoscopic or an open approach .

Treatment recommendations ideally are based on prospective, randomized trials comparing the current standard technique (TARH) with the proposed better technique (TLRH). However, there are currently no prospective studies available which directly compare TLRH against the standard treatment of TARH in regards to disease-free or overall survival.

The proposed clinical trial will be biphasic. The primary outcome variable in stage 1 will be feasibility of recruitment as determined by overall trial recruitment. Following completion of Stage 1, the data of this study will become the basis for assessing recurrence and disease-free survival in the Stage 2 design.

RATIONALE FOR THE QUALITY OF LIFE Retrospective studies suggest equivalency between the laparoscopic and open approaches to radical hysterectomy in regards to surgical specimens obtained and likely disease-free and overall survivals . Thus, quality of life could be seen as one of the most significant factors in recommending one approach over the other and therefore an extremely important endpoint for this protocol. In the GOG LAP-2 protocol , a trial evaluating a comparison between hysterectomy by laparotomy or laparoscopy, the investigators found equivalency adequacy of the two surgical approaches however a significant difference in short term quality of life favoring laparoscopy. As expected, patients who underwent laparoscopy had a faster return to baseline functioning compared with those patients who had undergone laparotomy which translated into improved short-term quality of life. By 6 months, however, patients in both cohorts were reporting equivalent quality of life parameters. Quality of life surveys employed with this Phase III clinical trial will encompass important endpoints such as postoperative pain and related symptoms using the MD Anderson Symptom Assessment Index (MDSAI), as well as cancer specific Functional Assessment of Cancer Therapy (FACT-Cx) and the general 12-Item Short-Form Health Survey (SF-12).

RATIONALE FOR LYMPHATIC MAPPING Published experience with the techniques for lymphatic mapping and sentinel lymph node detection in women with cervical cancer has been very limited. To date, no single study has enrolled more than 100 patients undergoing lymphatic mapping as part of their surgical treatment for cervical cancer. In fact, the majority of studies report on less than 50 patients. In addition, this procedure has not yet been shown to be viable in a multi-institutional setting. The limitations of previously published reports are important as these techniques are associated with a significantly high learning curve with early procedures less successful than later ones. This study will provide us the opportunity to enroll large numbers of patients for validation of intraoperative lymphatic mapping in women with cervical cancer in an international, multi-institutional setting.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: 1
    Total Abdominal Radical Hysterectomy
    Intervention: Procedure: Total Abdominal Radical Hysterectomy
  • Experimental: 2
    Total Laparoscopic or Robotic Radical Hysterectomy
    Intervention: Procedure: Total Laparoscopic or Robotic Radical Hysterectomy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 31, 2018)
636
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2008)
740
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   China,   Colombia,   Italy,   Korea, Republic of,   Mexico,   Peru,   Puerto Rico,   United States
Removed Location Countries Hong Kong,   India
 
Administrative Information
NCT Number  ICMJE NCT00614211
Other Study ID Numbers  ICMJE LACC001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Queensland Centre for Gynaecological Cancer
Study Sponsor  ICMJE Queensland Centre for Gynaecological Cancer
Collaborators  ICMJE M.D. Anderson Cancer Center
Investigators  ICMJE
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
PRS Account Queensland Centre for Gynaecological Cancer
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP