Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes

Vulvar Cancer Clinical Trial

Official title:

Phase III Radiation Therapy vs Pelvic Node Resection for Previously Untreated Invasive Squamous Cell Carcinoma of the Vulva With Positive Groin Nodes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00898352
• Other study ID #: CDR0000070950
• Secondary ID: GOG-37GOG-7712
• Status: Completed
• Phase: Phase 3
• First received: May 8, 2009
• Last updated: May 24, 2013

Study information

• Verified date: October 2009
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available

Description:

OBJECTIVES: I. Compare the efficacy of pelvic node resection vs. bilateral groin and pelvic node irradiation for invasive squamous cell carcinoma of the vulva in patients having positive groin nodes.

OUTLINE: Randomized study. Arm I: Surgery. Deep pelvic node dissection on sides containing positive nodes only. Arm II: Radiotherapy. Megavoltage (1 MeV or greater) to bilateral groin and pelvic nodes.

PROJECTED ACCRUAL: Anticipated annual accrual is approximately 200 patients, with an active phase estimated at 2.5-3 years. Protocol closed July 1984.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: November 1990
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Procedure:
• regional lymph node dissection

Radiation:
• radiation therapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

References & Publications (2)

Homesley HD, Bundy BN, Sedlis A, Adcock L. Radiation therapy versus pelvic node resection for carcinoma of the vulva with positive groin nodes. Obstet Gynecol. 1986 Dec;68(6):733-40. — View Citation

Kunos C, Simpkins F, Gibbons H, Tian C, Homesley H. Radiation therapy compared with pelvic node resection for node-positive vulvar cancer: a randomized controlled trial. Obstet Gynecol. 2009 Sep;114(3):537-46. doi: 10.1097/AOG.0b013e3181b12f99. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate			No
Primary	Survival rate			No
Primary	Subjective status on GOG performance scale			No
Primary	Time to recurrence			No
Primary	Survival time			No
Primary	Morbidity of treatment			Yes