Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer

Status unconfirmed · Not applicable

Conditions studied: Lymphedema, Stage IA Cervical Cancer, Stage IA Uterine Corpus Cancer, Stage IA Vulvar Cancer, Stage IB Cervical Cancer, Stage IB Uterine Corpus Cancer, Stage IB Vulvar Cancer, Stage II Uterine Corpus Cancer, Stage II Vulvar Cancer, Stage IIA Cervical Cancer, Stage IIIA Vulvar Cancer, Stage IIIB Vulvar Cancer, Stage IIIC Vulvar Cancer, Stage IVB Vulvar Cancer

In brief

This clinical trial studies lymphedema after surgery in patients with endometrial cancer, cervical cancer, or vulvar cancer. Collecting information over time about how often lymphedema occurs in patients undergoing surgery and lymphadenectomy for endometrial cancer, cervical cancer, and vulvar cancer may help doctors learn more about the disease and plan the best treatment.

Key facts

Study ID

NCT00956670

Run by

Gynecologic Oncology Group

People needed

1055

Starts

2012-06-01

Last updated by the study team

2017-05-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be registered into three distinct groupings, and each group will be analyzed as a separate study:
• Patients who will undergo or have undergone hysterectomy/bilateral salpingo-oophorectomy (BSO) and pelvic lymphadenectomy +/- para-aortic node sampling via open or laparoscopic technique for clinical stage I-II or surgical stage I-III uterine carcinoma, including those receiving postoperative adjuvant therapy; patients enrolling after surgery may have a pathologic stage of I-III OR
• Patients who will undergo or have undergone radical hysterectomy or trachelectomy and pelvic lymphadenectomy +/- para-aortic node sampling via open or laparoscopic technique for clinical stage IA-IIA cervical carcinoma, including those receiving postoperative adjuvant therapy OR
• Patients with vulvar cancer who will undergo or have undergone definitive surgery for primary stage I-IV vulvar cancer who will or have received a radical vulvectomy or radical local excision with concurrent unilateral or bilateral inguinal or inguinal-femoral lymphadenectomy; patients who are going to receive multi-modality therapy (radiation +/-chemotherapy) after undergoing surgery are eligible; patients may undergo sentinel node mapping as long as it is followed by a full lymphadenectomy; (note: enrollment of vulvar patients was closed on June 9, 2014; no vulvar patients will be enrolled after closure of this arm)
• Patients must have signed an approved informed consent and authorization permitting release of personal health information
• Patients must have a serum albumin level of >= 3.0 within 14 days of entry
• Surgery must occur within 5 business days before study entry or within eight weeks after study entry

You may not qualify if…

• Patients with any prior clinical history of lower extremity lymphedema
• Patients who have a history of congestive heart failure, chronic renal disease, or chronic liver disease
• Patients with a prior history of chronic lower extremity swelling
• Patients with a Gynecologic Oncology Group (GOG) performance grade of 3 or 4
• Patients with a history of other invasive malignancies if their previous cancer treatment included any of the surgical procedures
• Patients who have had prior lower extremity vascular surgery (arterial or venous)
• Patients who have had prior pelvic, abdominal, inguinal, or lower extremity radiation therapy
• Patients who have had or are going to receive another elective surgery during the same operative event as their pelvic (cervical or uterine cancers) or inguinal (vulvar) lymphadenectomy
• Vulvar patients, from June 9, 2014 on
• Patients cannot be enrolled on the trial unless there is at least one person at the participating site who has been trained in performing limb measurements
• Patients who do not undergo or have not undergone the lymphadenectomy portion of the procedure
• Patients who enter the study and then undergo sentinel node biopsy without the intention of undergoing complete lymphadenectomy

Where it is running

• Gynecologic Oncology Group of Arizona — Phoenix, Arizona, United States
• Saint Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Sutter Auburn Faith Hospital — Auburn, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Mills - Peninsula Hospitals — Burlingame, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• Sutter Davis Hospital — Davis, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States
• Memorial Medical Center — Modesto, California, United States
• Palo Alto Medical Foundation-Camino Division — Mountain View, California, United States
• Palo Alto Medical Foundation-Gynecologic Oncology — Mountain View, California, United States
• Sutter Cancer Research Consortium — Novato, California, United States
• Palo Alto Medical Foundation Health Care — Palo Alto, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Roseville — Roseville, California, United States
• Sutter Roseville Medical Center — Roseville, California, United States
• Sutter General Hospital — Sacramento, California, United States
• California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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