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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00614211
Ethics application status
Date submitted
31/01/2008
Date registered
13/02/2008
Date last updated
16/09/2020

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 - Compare treatment equivalence
Timepoint [1] 0 0
5 years from surgery
Secondary outcome [1] 0 0
Patterns of recurrence - date and localization of 1st recurrence as confirmed histologically - Compare patterns between groups
Timepoint [1] 0 0
5 years from surgery
Secondary outcome [2] 0 0
Costs - Compare costs between groups
Timepoint [2] 0 0
6 months from surgery
Secondary outcome [3] 0 0
Quality of life Questionnaires - Compare QoL between groups
Timepoint [3] 0 0
6 months from surgery
Secondary outcome [4] 0 0
Pelvic Floor Distress Inventory Questionnaire - Compare PFDI between groups
Timepoint [4] 0 0
5 years from surgery
Secondary outcome [5] 0 0
Overall survival - Compare between groups
Timepoint [5] 0 0
5 years from surgery
Secondary outcome [6] 0 0
Feasibility of sentinel lymph node biopsy - Compare between groups
Timepoint [6] 0 0
Intra-operatively
Secondary outcome [7] 0 0
Intra-operative, peri-operative, post-operative and long term treatment related morbidity - Compare these between groups
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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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
Other publications