Pre-Operative Assessment and Post-Operative Outcomes of Elderly Women With Gynecologic Cancers
The study is for patients 70 years and older who are newly diagnosed with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma. Using a brief modified version of the Comprehensive Geriatric Assessment Survey (CGAS) at the pre-operative stage and some blood work, Gynecologic Oncologists would derive a score from a predictive model and follow these patients prospectively through non randomized treatment (both surgery and chemotherapy). The scores would then be associated to outcomes postoperatively, including complications and the ability to remove tumors in patients.
The modified Geriatric Assessment questionnaire includes several measures (function, physical performance, comorbidity, nutrition, social support, social activity, cognition, psychological status, medications list) and risk factors (need for assistance, limited physical activity, number of falls, level of hearing, age, hemoglobin, creatinine clearance).
Study phase: Other
Study phase (if other): Observational
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Subjects must fulfill the following criteria in order to be eligible to be controls:
• Have suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma irrespective of performance status as determined by the
• Sign an approved informed consent and authorization permitting release of personal health information.
• Must be 70 years of age or older.
• Must understand sufficiently to be able to respond to questions posed by the study instruments.
Subjects meeting any of the following criteria are ineligible to be controls:
• Circumstances at the time of study entry do not permit completion of the study or required
• Planned surgery to be performed is of the minimally invasive technique (MIS).
• Received chemotherapy treatment (for a gynecologic malignancy) prior to consideration of enrollment into this trial and taking the geriatric assessment.
• Known pre-operative primary uterine cancer, confirmed by endometrial biopsy.
Primary disease category: Cancer
Sponsor: NRG Oncology
Protocol number: CC-002
Projected enrollment dates: August 2015 to December 2020
Official study title: Pre-Operative Assessment and Post-Operative Outcomes of Elderly Women With Gynecologic Cancers