GOG-0278
Terminated
Protocol Information
Evaluation of Physical Function and Quality of Life (QOL) Before and After Non-Radical Surgical Therapy (Extra Fascial Hysterectomy or Cone Biopsy with Pelvic Lymphadenectomy) for Stage IA1 (LVSI+) and IA2-IB1 (=/<2CM) Cervical Cancer
Principal Investigator
Status
Terminated
Open to Accrual
October 1, 2012
Closed to Accrual
October 14, 2021
Closed to Accrual & Treatment
October 29, 2021
Complete
March 7, 2025
Terminated
March 7, 2025
Disease Site
Gynecologic [GY] Cervix
Phase
Other
Developmental Therapeutics
No
Primary Objective
To examine the changes before and after non-radical surgical treatment (simple hysterectomy or cone biopsy [fertility preservation]) and pelvic lymphadenectomy) on functional outcomes of bladder, bowel and sexual function for stage IA1 (LVSI+) and IA2-IB1 (<2cm) carcinoma of the cervix.
To evaluate incidence and severity of lymphedema after non-radical surgery (simple hysterectomy or cone biopsy [fertility preservation] and pelvic lymphadenectomy) for stage IA1 (LVSI+) and IA2-IB1 (<2cm) carcinoma of the cervix.
Patient Population
Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma or adenosquamous cell carcinoma of the cervix, Stage IA1 (LVSI+), IA2, and IB1 (tumor size [maximum visible or palpable]) ≤ 2cm), any grade.
Target Accrual
220
- 0278-IC-Amendment-1-tracked.pdf
- 0278-IC-Amendment-2-Tracked.docx
- 0278-IC-Amendment-2.docx
- 0278-IC-Amendments-3and4-Tracked.docx
- 0278-IC-Amendments-3and4.docx
- GOG-0278-consent_version_date_Oct_31_2018_tracked.docx
- GOG-0278_IC_Amendment5_version_date_August_23_2018.docx
- GOG-0278_IC_Amendment5_version_date_August_23_2018_tracked.docx
Appendix I-IV