Status:
UNKNOWN
Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer
Lead Sponsor:
Gynecologic Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphedema
Stage IA Cervical Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 patie...
Detailed Description
PRIMARY OBJECTIVES: I. To prospectively estimate the incidence of lower extremity lymphedema in patients undergoing radical surgery with a concurrent lymphadenectomy with a concurrent lymphadenectomy...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
1055 Patients enrolled
Trial Details
Trial ID
NCT00956670
Start Date
June 1 2012
Last Update
May 8 2017
Active Locations (213)
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1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
2
Gynecologic Oncology Group of Arizona
Phoenix, Arizona, United States, 85012
3
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
4
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054