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OpenTrials
Completed

NCT Number: NCT00898352

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

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available

Completed

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Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS: See General Eligibility Criteria

PATIENT CHARACTERISTICS: See General Eligibility Criteria

Treatment and study plan

regional lymph node dissection

Procedure

radiation therapy

Radiation

Primary outcomes

  1. Recurrence rate

  2. Survival rate

  3. Subjective status on GOG performance scale

  4. Time to recurrence

  5. Survival time

  6. Morbidity of treatment

Sponsors and collaborators

Lead sponsor

Gynecologic Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Primary completion
1990
First posted
May 12, 2009
Registry last updated
May 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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