Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-01-10 @ 2:19 PM
Study NCT ID:
NCT02315469
Status:
COMPLETED
Last Update Posted:
2021-11-24
First Post:
2014-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Patient Questionnaires in Predicting Complications in Older Patients With Gynecologic Cancer Undergoing Surgery
Sponsor:
NRG Oncology
Organization:
Study Overview
Official Title:
Pre-operative Assessment and Post-Operative Outcomes of Elderly Women With Gynecologic Cancers
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research trial studies comprehensive patient questionnaires in predicting complications in older patients with gynecologic cancer undergoing surgery. Comprehensive patient questionnaires completed before surgery may help identify complications, such as the need for assistance in taking medications, decreased mobility, decreased social activity, and falls, and may improve outcomes for older patients with gynecologic cancer.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-01376 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| GOG-ELD1301 | None | None | View | |
| NRG-CC002 | OTHER | NRG Oncology | View | |
| NRG-CC002 | OTHER | DCP | View | |
| NRG-CC002 | OTHER | CTEP | View | |
| U10CA101165 | NIH | None | https://reporter.nih.gov/quic… | View |
| UG1CA189867 | NIH | None | https://reporter.nih.gov/quic… | View |