Pre-Operative Assessment and Post-Operative Outcomes of Elderly Women with Gynecologic Cancers

Eligibility Criteria
3.1.1 Patients with suspected ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous uterine carcinoma irrespective of performance status. This clinical determination is made by the treating physician.
3.1.2 Patients must have signed an approved informed consent and authorization permitting release of personal health information.
3.1.3 Patients must be 70 years of age or older.
3.1.4 Patients who can understand sufficiently to be able to respond to questions posed by the study instruments.
3.1.5 Patients and/or caregiver (durable power of attorney) can give consent and
caregiver can assist with the responses to questionnaire.
NOTE: It is the intent of this trial that all patients 70 years or older presenting to the participating physician/center be offered enrollment onto this study. Eligible patients may enroll and subsequently receive neoadjuvant chemotherapy followed by interval surgery, primary cytoreductive surgery or no surgery at all.
Ineligible Patients
3.2.1 Patients whose circumstances at the time of study entry do not permit
completion of the study or required follow-up.
3.2.2 Patients who would have planned surgery performed by the minimally invasive
technique. Institutions which perform cytoreductive surgery via the minimally invasive technique should not participate in this study. Minimally invasive surgery (MIS) has been shown to be feasible without significant morbidity in elderly women treated for gynecologic cancers. (Hintze,
2008; Walker et al, 2009; Frey et al, 2011; Ciavattini et al, 2014) Given the low morbidity with the MIS approach, the primary endpoint may not be reached using the MIS approach in this patient
population. The MIS technique is also not considered standard technique for primary cytoreductive surgery for advanced stage ovarian, fallopian tube or peritoneal cancers. (Wright et al, 2012;
Moore et al, 2008; Chi et al, 2012; Ciavattini et al, 2014)
3.2.3 Patients who receive chemotherapy treatment (for a gynecologic malignancy)
prior to consideration of enrollment into this trial and taking the geriatric assessment will be excluded.
3.2.4 Patients who have a known pre-operative primary uterine cancer, confirmed by endometrial biopsy.
3.2.5 Post-operative pathology will not exclude patients from this study.