Laparoscopic Approach to Cervical Cancer

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIITreatmentActive18 and overLACC001
NCI-2014-01556, NCT00614211

Trial Description

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.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Royal Brisbane and Women's Hospital

  • M D Anderson Cancer Center CCOP Research Base

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00614211

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.