Lymphedema After Surgery in Patients With Endometrial Cancer, Cervical Cancer, or Vulvar Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 12-007809
- Rochester, Minnesota: 12-007809
NCT ID: NCT00956670
Sponsor Protocol Number: GOG-0244
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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
- 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 Criteria:
- 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
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
Contact |
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Paul Magtibay, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
Rochester, Minn.
Mayo Clinic principal investigator Andrea Wahner Hendrickson, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available