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New treatment option for Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Official title Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
ClinicalTrials.gov ID: NCT05646316
What this study is testing
What is Indocyanine Green Solution?
Indocyanine Green Solution is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for stage i uterine corpus carcinoma or carcinosarcoma ajcc v8.
Also referred to as IC-GREEN, ICG Solution.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and...
- Clinical stage I endometrial cancer based on the following diagnostic workup:
- History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
You likely can't join if
- Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e...
- History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol...
- History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes
- Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy...
- Patients with severe, active co-morbidity defined as follows:
- History of patient or provider identified lower extremity lymphedema
See the full eligibility criteria
- Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and lymphatic assessment as part of primary management. Biopsy must be...
- Clinical stage I endometrial cancer based on the following diagnostic workup:
- History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal...
- Patients must speak English, Spanish, or Korean
- Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery)
- History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are...
- History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes
- Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)
- Patients with severe, active co-morbidity defined as follows:
- History of patient or provider identified lower extremity lymphedema
- History of patient or provider identified chronic lower extremity swelling
- History of lower extremity or pelvic deep venous thromboembolism within 90 days of registration
- History of lower extremity cellulitis within 90 days of registration
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Doral, Florida, United States
- Miami, Florida, United States
- North Miami, Florida, United States
- Plantation, Florida, United States
- Augusta, Georgia, United States
- Chicago, Illinois, United States
- Warrenville, Illinois, United States
- Carmel, Indiana, United States
- Indianapolis, Indiana, United States
- Marrero, Louisiana, United States
- Metairie, Louisiana, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Bel Air, Maryland, United States
- Detroit, Michigan, United States
- Farmington Hills, Michigan, United States
- Flint, Michigan, United States
+ 24 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Coral Gables, Florida, United States; Deerfield Beach, Florida, United States; Doral, Florida, United States; Miami, Florida, United States; North Miami, Florida, United States and 38 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.