Radiation Therapy or Surgery in Treating Patients With Previously Untreated Vulva Cancer With Positive Groin Lymph Nodes
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ClinicalTrials.gov Identifier: NCT00898352 |
Recruitment Status
:
Completed
First Posted
: May 12, 2009
Last Update Posted
: May 27, 2013
|
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RATIONALE: Patient abstract not available
PURPOSE: Patient abstract not available
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vulvar Cancer | Procedure: regional lymph node dissection Radiation: radiation therapy | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Official Title: | Phase III Radiation Therapy vs Pelvic Node Resection for Previously Untreated Invasive Squamous Cell Carcinoma of the Vulva With Positive Groin Nodes |
Actual Primary Completion Date : | November 1990 |

- Recurrence rate
- Survival rate
- Subjective status on GOG performance scale
- Time to recurrence
- Survival time
- Morbidity of treatment

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: See General Eligibility Criteria

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898352
Study Chair: | George C. Lewis, MD | Sidney Kimmel Cancer Center at Thomas Jefferson University |
Publications of Results:
Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
ClinicalTrials.gov Identifier: | NCT00898352 History of Changes |
Other Study ID Numbers: |
CDR0000070950 GOG-37 GOG-7712 |
First Posted: | May 12, 2009 Key Record Dates |
Last Update Posted: | May 27, 2013 |
Last Verified: | October 2009 |
Keywords provided by Gynecologic Oncology Group:
stage III vulvar cancer squamous cell carcinoma of the vulva |
Additional relevant MeSH terms:
Vulvar Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Neoplasms Vulvar Diseases Genital Diseases, Female |