Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003325
Status:
COMPLETED
Last Update Posted:
2015-05-29
First Post:
1999-11-01
Brief Title:
Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva
Status:
COMPLETED
Status Verified Date:
2015-05
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:
RATIONALE Lymphatic mapping may improve the ability to detect cancer of the vulva
PURPOSE This phase III trial is studying how well lymphatic mapping works in treating patients with stage I or stage II cancer of the vulva
PURPOSE This phase III trial is studying how well lymphatic mapping works in treating patients with stage I or stage II cancer of the vulva
Detailed Description:
OBJECTIVES
Determine the negative predictive value of a negative sentinel lymph node in patients with invasive squamous cell carcinoma of the vulva
Determine the location of the sentinel node in these patients
OUTLINE Patients receive injections of isosulfan blue into the dermis at the junction of the tumor and normal vulvar skin Once the afferent lymphatic channel and sentinel node have been identified patients undergo unilateral or bilateral inguinal-femoral lymphadenectomy followed by resection of the primary tumor with adequate margins Preoperative lymphoscintigraphy is also performed
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter or until recurrence
PROJECTED ACCRUAL A total of 40-630 patients will be accrued for this study within 2-6 years
Determine the negative predictive value of a negative sentinel lymph node in patients with invasive squamous cell carcinoma of the vulva
Determine the location of the sentinel node in these patients
OUTLINE Patients receive injections of isosulfan blue into the dermis at the junction of the tumor and normal vulvar skin Once the afferent lymphatic channel and sentinel node have been identified patients undergo unilateral or bilateral inguinal-femoral lymphadenectomy followed by resection of the primary tumor with adequate margins Preoperative lymphoscintigraphy is also performed
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter or until recurrence
PROJECTED ACCRUAL A total of 40-630 patients will be accrued for this study within 2-6 years
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2009-00579 | OTHER | NCI | None |
| CDR0000066277 | OTHER | None | None |