Laparoscopic Approach to Cervical Cancer (LACC)
This study is currently recruiting participants.
Verified June 2013 by Queensland Centre for Gynaecological Cancer
Sponsor:
Queensland Centre for Gynaecological Cancer
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Queensland Centre for Gynaecological Cancer
ClinicalTrials.gov Identifier:
NCT00614211
First received: January 31, 2008
Last updated: June 5, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer |
Procedure: Total Abdominal Radical Hysterectomy Procedure: Total Laparoscopic or Robotic Radical Hysterectomy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase III Randomized Clinical Trial of Laparoscopic or Robotic Radical Hysterectomy Versus Abdominal Radical Hysterectomy in Patients With Early Stage Cervical Cancer |
Resource links provided by NLM:
Further study details as provided by Queensland Centre for Gynaecological Cancer:
Primary Outcome Measures:
- Disease free survival [ Time Frame: 5 years from surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patterns of recurrence [ Time Frame: 5 years from surgery ] [ Designated as safety issue: No ]
- Costs [ Time Frame: 6 months from surgery ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 6 months from surgery ] [ Designated as safety issue: No ]
- Pelvic Floor Distress Inventory [ Time Frame: 5 years from surgery ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 5 years from surgery ] [ Designated as safety issue: No ]
- Feasibility of sentinel lymph node biopsy [ Time Frame: Intra-operatively ] [ Designated as safety issue: No ]
- Intra-operative, peri-operative, post-operative and long term treatment related morbidity [ Time Frame: 6 months from surgery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 740 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | July 2022 |
| Estimated Primary Completion Date: | July 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Total Abdominal Radical Hysterectomy
|
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:
|
|
Experimental: 2
Total Laparoscopic or Robotic 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:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614211
Show 33 Study Locations
Contacts
| Contact: Vanessa Behan, BNursing | +61 7 3646 4343 | Vanessa_Behan@health.qld.gov.au |
| Contact: Pedro Ramirez | peramire@mdanderson.org |
Show 33 Study LocationsSponsors and Collaborators
Queensland Centre for Gynaecological Cancer
M.D. Anderson Cancer Center
Investigators
| 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 |
More Information
Additional Information:
QCGC Research 
Publications:
| Responsible Party: | Queensland Centre for Gynaecological Cancer |
| ClinicalTrials.gov Identifier: | NCT00614211 History of Changes |
| Other Study ID Numbers: | LACC001 |
| Study First Received: | January 31, 2008 |
| Last Updated: | June 5, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee Australia: National Health and Medical Research Council United States: Institutional Review Board |
Keywords provided by Queensland Centre for Gynaecological Cancer:
|
Uterine cervix Cervix Cervical Cancer Carcinoma Radical hysterectomy Hysterectomy Laparoscopy Laparoscopic |
Robotic Squamous Cell Adenosquamous Adenocarcinoma Lymphatic Mapping IOLM SPECT Sentinel Node |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on June 17, 2013