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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00614211




Registration number
NCT00614211
Ethics application status
Date submitted
31/01/2008
Date registered
13/02/2008
Date last updated
18/04/2023

Titles & IDs
Public title
Laparoscopic Approach to Cervical Cancer
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] 0 0
LACC001
Universal Trial Number (UTN)
Trial acronym
LACC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Total Abdominal Radical Hysterectomy
Treatment: Surgery - Total Laparoscopic or Robotic Radical Hysterectomy

Active Comparator: 1 - Total Abdominal Radical Hysterectomy

Experimental: 2 - Total Laparoscopic or Robotic Radical Hysterectomy


Treatment: Surgery: 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.

Treatment: Surgery: 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.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease free survival
Timepoint [1] 0 0
5 years from surgery
Secondary outcome [1] 0 0
Patterns of recurrence
Timepoint [1] 0 0
5 years from surgery
Secondary outcome [2] 0 0
Costs
Timepoint [2] 0 0
6 months from surgery
Secondary outcome [3] 0 0
Quality of life Questionnaires
Timepoint [3] 0 0
6 months from surgery
Secondary outcome [4] 0 0
Pelvic Floor Distress Inventory Questionnaire
Timepoint [4] 0 0
5 years from surgery
Secondary outcome [5] 0 0
Overall survival
Timepoint [5] 0 0
5 years from surgery
Secondary outcome [6] 0 0
Feasibility of sentinel lymph node biopsy
Timepoint [6] 0 0
Intra-operatively
Secondary outcome [7] 0 0
Intra-operative, peri-operative, post-operative and long term treatment related morbidity
Timepoint [7] 0 0
6 months from surgery

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2022
Sample size
Target
Accrual to date
Final
636
Recruitment in Australia
Recruitment state(s)
QLD,WA
Recruitment hospital [1] 0 0
The Wesley Hospital - Auchenflower
Recruitment hospital [2] 0 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Mater Health Services - South Brisbane
Recruitment hospital [5] 0 0
The Townsville Hospital - Townsville
Recruitment hospital [6] 0 0
Saint John of God - Subiaco
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
4814 - Townsville
Recruitment postcode(s) [6] 0 0
- Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
Nevada
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Oklahoma
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Wisconsin
Country [7] 0 0
Argentina
State/province [7] 0 0
Cordoba
Country [8] 0 0
Brazil
State/province [8] 0 0
Parana
Country [9] 0 0
Brazil
State/province [9] 0 0
San Paulo
Country [10] 0 0
Brazil
State/province [10] 0 0
Sao Paulo
Country [11] 0 0
Brazil
State/province [11] 0 0
SP
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Pleven
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
China
State/province [14] 0 0
Guangdong
Country [15] 0 0
China
State/province [15] 0 0
Zhejiang
Country [16] 0 0
Colombia
State/province [16] 0 0
Medellin
Country [17] 0 0
Italy
State/province [17] 0 0
Milan
Country [18] 0 0
Italy
State/province [18] 0 0
Rome
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul
Country [20] 0 0
Mexico
State/province [20] 0 0
Mexico City
Country [21] 0 0
Peru
State/province [21] 0 0
Surquillo
Country [22] 0 0
Puerto Rico
State/province [22] 0 0
Caguas

Funding & Sponsors
Primary sponsor type
Other
Name
Queensland Centre for Gynaecological Cancer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
M.D. Anderson Cancer Center
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00614211
Trial related presentations / publications
Obermair A, Gebski V, Frumovitz M, Soliman PT, Schmeler KM, Levenback C, Ramirez PT. A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy with abdominal radical hysterectomy in patients with early stage cervical cancer. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):584-8. doi: 10.1016/j.jmig.2008.06.013.
Public notes

Contacts
Principal investigator
Name 0 0
Pedro Ramirez, M.D.
Address 0 0
M.D. Anderson Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00614211