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Sponsors and Collaborators: |
Queensland Centre for Gynaecological Cancer M.D. Anderson Cancer Center |
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Information provided by: | Queensland Centre for Gynaecological Cancer |
ClinicalTrials.gov Identifier: | NCT00614211 |
The primary objective of this study is to assess disease-free survival at 4.5 years postoperatively amongst patients who undergo a Total Laparoscopic (TLRH) or Total Robotic Radical Hysterectomy versus those who undergo a Total Abdominal Radical Hysterectomy for the treatment of early stage cervical cancer.
Condition | Intervention | Phase |
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Cervical Cancer |
Procedure: Total Abdominal Radical Hysterectomy Procedure: Total Laparoscopic or Robotic Radical Hysterectomy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
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 |
Estimated Enrollment: | 740 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | July 2017 |
Estimated Primary Completion Date: | July 2017 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Total Abdominal Radical Hysterectomy
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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.
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2: Experimental
Total Laparoscopic or Robotic Radical Hysterectomy
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Trudi Cattley, BAppSc | +61 7 3636 0447 | Trudi_Cattley@health.qld.gov.au |
Contact: Pedro Ramirez | peramire@mdanderson.org |
United States, Texas | |
M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States | |
Contact: Pedro Ramirez, M.D. peramire@mdanderson.org | |
Contact: Maria Jung mjung@mdanderson.org | |
Principal Investigator: Pedro Ramirez, M.D. | |
Australia, Queensland | |
Royal Brisbane and Women's Hospital | Recruiting |
Herston, Queensland, Australia, 4029 | |
Contact: Andreas Obermair, MD FRANZCOG CGO +61 7 3636 8501 andreas_obermair@health.qld.gov.au | |
Contact: Trudi Cattley, BAppSc +61 7 3636 1722 Trudi_Cattley@health.qld.gov.au | |
Principal Investigator: Andreas Obermair, MD FRANZCOG COG | |
Sub-Investigator: Russell Land | |
Greenslopes Private Hospital | Recruiting |
Greenslopes, Queensland, Australia, 4120 | |
Contact: Trudi Cattley 07 3636 0447 Trudi_Cattley@health.qld.gov.au | |
Principal Investigator: Andreas Obermair | |
Sub-Investigator: Russell Land | |
The Wesley Hospital | Recruiting |
Auchenflower, Queensland, Australia, 4066 | |
Contact: Trudi Cattley 07 3636 0447 Trudi_Cattley@health.qld.gov.au | |
Principal Investigator: Russell Land |
Study Chair: | Pedro Ramirez, M.D. | M.D. Anderson Cancer Center |
Study Chair: | Andreas Obermair, MD FRANZCOG CGO | Queensland Centre for Gynecological Cancer |
Study Chair: | Michael Frumovitz, M.D. | M.D. Anderson Cancer Center |
Responsible Party: | M.D. Anderson Cancer Center ( Associate Professor Pedro Ramirez ) |
Study ID Numbers: | LACC001 |
Study First Received: | January 31, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00614211 |
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 |
Cervix Cervical Cancer Carcinoma Radical hysterectomy Hysterectomy Laparoscopy |
Laparoscopic Robotic Adenocarcinoma Lymphatic Mapping IOLM Sentinel Node Uterine cervix |
Adenocarcinoma Carcinoma |