Comprehensive Patient Questionnaires in Predicting Complications in Older Patients With Gynecologic Cancer Undergoing Surgery

PRIMARY OBJECTIVES:

I. To determine whether the preoperative geriatric assessment (GA)-gynecology (GYN) score
will be associated with major post-operative complications in elderly patients undergoing
open primary cytoreduction surgery.

SECONDARY OBJECTIVES:

I. To explore associations between individual variables of the preoperative geriatric
assessment and major post-operative complications in patients undergoing open primary
cytoreduction surgery.

II. To assess the association between the preoperative GA-GYN score and cytoreducibility
defined by extent of residual disease in patients undergoing open primary cytoreduction
surgery.

TERTIARY OBJECTIVES :

I. To evaluate whether the preoperative GA-GYN scores obtained before and after neoadjuvant
chemotherapy will be associated with major postoperative complications in elderly patients
undergoing open interval cytoreduction surgery.

II. To describe reasons why surgeons at centers where open cytoreduction surgery is the
standard of care choose to perform interval surgery vs primary surgery, and to explore the
association of the preoperative GA-GYN score with the decision to perform primary surgery or
interval surgery or no surgery.

III. To collect the following specific information on how elderly women with suspected
ovarian, fallopian tube, primary peritoneal carcinomas or advanced stage papillary serous
uterine carcinoma are treated at centers that consider open cytoreduction surgery the
standard of care: (1) the percentage of patients treated with primary open cytoreduction vs.
interval open cytoreduction vs. no surgery and (2) to ascertain the extent of cytoreduction.

IV. To determine whether neoadjuvant chemotherapy will be associated with changes in the
GA-GYN score to change by comparing the GA-GYN scores obtained before and after neoadjuvant
chemotherapy.

V. To determine whether 30-day readmission rates after cytoreductive surgery correlate with
the GA-GYN score.

OUTLINE:

At time of consent and within 14 days of surgery, patients complete a pre-operative
geriatric assessment that evaluates functional status, comorbid medical conditions,
psychological state, social support, and nutritional status. Post-operative complications
are also collected for 6 weeks after surgery or until the date patients initiate or restart
chemotherapy whichever is first.

Inclusion Criteria:

- 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

- Patients must have signed an approved informed consent and authorization permitting
release of personal health information

- Patients who can understand sufficiently to be able to respond to questions posed by
the study instruments

- 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

- Post-operative pathology will not exclude patients from this study

Exclusion Criteria:

- Patients whose circumstances at the time of study entry do not permit completion of
the study or required follow-up

- 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; the minimally invasive
surgery (MIS) technique is also not considered standard technique for primary
cytoreductive surgery for advanced stage ovarian, fallopian tube or peritoneal
cancers

- 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

- Patients who have a known pre-operative primary uterine cancer, confirmed by
endometrial biopsy