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| ID | Type | Description | Link |
|---|---|---|---|
| GOG-37 | |||
| GOG-7712 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Patient abstract not available
PURPOSE: Patient abstract not available
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| regional lymph node dissection | Procedure | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | ||
| Survival rate | ||
| Subjective status on GOG performance scale | ||
| Time to recurrence | ||
| Survival time | ||
| Morbidity of treatment |
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DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: See General Eligibility Criteria
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| Name | Affiliation | Role |
|---|---|---|
| George C. Lewis, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19701032 | Result | 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. | |
| 3785783 | 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. |
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| ID | Term |
|---|---|
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| D014845 |
| Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |