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Trial registered on ANZCTR


Registration number
ACTRN12608000019303
Ethics application status
Approved
Date submitted
8/01/2008
Date registered
14/01/2008
Date last updated
14/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Laparoscopic Approach to Cervical Carcinoma
Scientific title
A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy versus Abdominal Radical Hysterectomy in Patients with Early Stage Cervical Cancer
Secondary ID [1] 252180 0
NCT00614211 - ClinicalTrials.Gov
Universal Trial Number (UTN)
Trial acronym
LACC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer 2674 0
Condition category
Condition code
Cancer 2810 2810 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The surgery is a Radical Hysterectomy performed laparoscopically or robotically for the treatment of cervical cancer. This involves the removal of the uterus, the upper one to two centimetres of the vagina and the soft tissues around the cervix.The surgical procedure takes 2-4 hours.
Intervention code [1] 2416 0
Treatment: Surgery
Intervention code [2] 2428 0
Treatment: Surgery
Comparator / control treatment
The surgery is a Radical Hysterectomy performed through the abdomen for the treatment of cervical cancer. This involves the removal of the uterus, the upper one to two centimetres of the vagina and the soft tissues around the cervix. The surgical procedure takes 2-3 hours.
Control group
Active

Outcomes
Primary outcome [1] 3684 0
To compare disease free survival amongst patients who undergo a total laparoscopic radical hysterctomy (TLRH) versus those who undergo a total abdominal radical hysterectomy (TARH) for early stage cervical cancer
Timepoint [1] 3684 0
Disease free survival at 4.5 years post surgery
Secondary outcome [1] 6214 0
Compare treatment-associated morbidity
Timepoint [1] 6214 0
Up to 6 months post surgery
Secondary outcome [2] 6255 0
Compare patterns of recurrence between arms
Timepoint [2] 6255 0
4.5 years post surgery
Secondary outcome [3] 6256 0
Compare the cost effectiveness of TLRH vs TARH
Timepoint [3] 6256 0
Up to 6 months post surgery
Secondary outcome [4] 6257 0
Compare the Quality of Life (QoL) between arms
Timepoint [4] 6257 0
Up till 6 months post surgery
Secondary outcome [5] 6258 0
Assess pelvic floor function
Timepoint [5] 6258 0
Up to 4.5 years post surgery
Secondary outcome [6] 6259 0
Compare overall survival between arms
Timepoint [6] 6259 0
At 4.5 years post surgery
Secondary outcome [7] 6260 0
Determine the feasibility of sentinel lymph node biopsy in this group of patients
Timepoint [7] 6260 0
N/A

Eligibility
Key inclusion criteria
1. Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
2. Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA1 (with lymph vascular space invasion), IA2, or IB1 disease;
3. Patients undergoing either a Type II or III radical hysterectomy (Piver Classification)
4. Patients with adequate bone marrow, renal and hepatic function:
4.1 White Blood Cells (WBC) > 3,000 cells/mcl
4.2 Platelets >100,000/mcl
4.3 Creatinine <2.0 mg/dL (Non-Isotope dilution mass spectrometry (non – IDMS))
4.4 Bilirubin <1.5 x normal and Serum Glutamic Oxaloacetic Transaminase (SGOT) or Serum Glutamic Pyruvic Transaminase (SGPT) <3 x normal
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
6. Patient must be suitable candidates for surgery;
7. Patients who have signed an approved Informed Consent;
8. Patients with a prior malignancy allowed if > 5 years previous with no current evidence of disease;
9. Females, aged 18 years or older.
10. Negative serum pregnancy test within 30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause
Minimum age
18 Years
Maximum age
N/A
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any histological type other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
2. Tumor size greater than 4 cm;
3. FIGO stage II-IV;
4. Patients with a history of pelvic or abdominal radiotherapy;
5. Patients who are pregnant;
6. Patients with contraindications to surgery;
7. Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes > 2cm; or histologically positive lymph nodes 8. Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
9. Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
10. Patient compliance and geographic proximity that do not allow adequate follow-up.
11. Patients who agree to intra-operative lymphatic mapping (IOLM) must not have: - Known allergies to triphenylmethane compounds. - History of retroperitoneal surgery. - History of pelvic irradiation. - Cold knife or loop electrosurgical excision procedure (LEEP) cone biopsy within 4 wks of enrollment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible patients will be required to provide informed signed consent before being randomized. Prior to randomization, each patient will be screened for eligibility according to the inclusion and exclusion criteria. A web-based computer randomization procedure will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed using the method of minimization with an equal allocation between the two treatment groups. Randomizations will be stratified according to treating centre, and disease stage as determined clinically according to the current FIGO guidelines and patient’s age (< or = 70 and > 70 years).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
740
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 542 0
4029
Recruitment outside Australia
Country [1] 723 0
United States of America
State/province [1] 723 0
Texas

Funding & Sponsors
Funding source category [1] 2934 0
Self funded/Unfunded
Name [1] 2934 0
Queensland Centre for Gynecological Cancer
Country [1] 2934 0
Australia
Primary sponsor type
University
Name
M.D Anderson Cancer Centre
Address
Department of Gynecologic Oncology The University of Texas Main Campus
1515 Holcombe Blvd.
Houston, TX 77030
1-877-MDA-6789

Postal Address
PO BOX 301439
Houston TX 77230-1439
Country
United States of America
Secondary sponsor category [1] 2648 0
University
Name [1] 2648 0
Queensland Centre for Gynecological Cancer
Address [1] 2648 0
University of Queenland Lvl 6, Ned Hanlon Building Royal Brisbane and Women's Hospital Herston QLD 4029
Country [1] 2648 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4878 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 4878 0
Lvl 7, Block 7
Royal Brisbane and Women's Hospital
Herston QLD 4029
Ethics committee country [1] 4878 0
Australia
Date submitted for ethics approval [1] 4878 0
23/10/2007
Approval date [1] 4878 0
22/01/2008
Ethics approval number [1] 4878 0
2007/159

Summary
Brief summary
We are conducting a Phase III Randomized Clinical Trial Comparing Laparoscopic or Robotic Radical Hysterectomy versus Abdominal Radical Hysterectomy in Patients with Early Stage Cervical Cancer.

The primary objective of this study is to compare disease-free survival amongst patients who undergo a total laparoscopic or robotic radical hysterectomy (TLRH/TRRH) versus those who undergo a total abdominal radical hysterectomy (TARH) for early stage cervical cancer.

Method 1 is the standard approach worldwide and consists of a laparotomy where the abdomen is opened through a vertical incision or a lower transverse incision and the uterus, the upper one to two centimetres of the vagina and soft tissue around the cervix are removed. Method 2 is a relatively new method where the operation is performed laparoscopically.

The rationale for the study design is that 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/Robotic techniques have been demonstrated to be feasible and safe with previous retrospective studies on Total Laparoscopic/Robotic Hysterectomies 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/robotic hysterectomy compared to patients who underwent a Total Abdominal Hysterectomy. Retrospective data suggest that the recurrence rate and patterns of recurrence are similar in patients who had a laparoscopic/robotic 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/TRRH). However, there are currently no prospective studies available which directly compare Total Laparoscopic/Robotic Radical Hysterectomy against the standard treatment of Total Abdominal Radical Hysterectomy in regards to disease-free or overall survival.
Trial website
www.gyncan.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28275 0
Address 28275 0
Country 28275 0
Phone 28275 0
Fax 28275 0
Email 28275 0
Contact person for public queries
Name 11432 0
Vanessa Behan
Address 11432 0
Queensland Centre for Gynecological Cancer
Lvl 6, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 11432 0
Australia
Phone 11432 0
+61 7 3636 4343
Fax 11432 0
+61 7 3636 1721
Email 11432 0
[email protected]
Contact person for scientific queries
Name 2360 0
Professor Andreas Obermair
Address 2360 0
Queensland Centre for Gynecological Cancer
Lvl 6, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 2360 0
Australia
Phone 2360 0
07 3636 8501
Fax 2360 0
Email 2360 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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