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

NCT00898352 | Completed Phase 3

• 3 other identifiers: CDR0000070950GOG-37GOG-7712
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Patient abstract not available PURPOSE: Patient abstract not available

Conditions

Vulvar Cancer

Keywords

stage III vulvar cancer; squamous cell carcinoma of the vulva

Outcome Measures

Primary Outcomes (6)

• Recurrence rate

• Survival rate

• Subjective status on GOG performance scale

• Time to recurrence

• Survival time

• Morbidity of treatment

Interventions

regional lymph node dissection PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: See General Eligibility Criteria PATIENT CHARACTERISTICS: See General Eligibility Criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Related Publications (2)

• 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):537-546. doi: 10.1097/AOG.0b013e3181b12f99.

  PMID: 19701032 RESULT

• 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.

  PMID: 3785783 RESULT

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• George C. Lewis, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 12, 2009
• Primary Completion: November 1, 1990
• Last Updated: May 27, 2013

Record last verified: 2009-10