NCT02642471Active, not recruiting
Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early-stage Cervical Cancer (PHENIX/CSEM 010)
Source: ClinicalTrials.gov · Last updated 16 Dec 2024
Brief summary (registry, in English)
The diagnostic value of sentinel lymph node biopsy in early-stage cervical cancer has been well studied. However, there were no randomized controlled study on comparing the long-term outcomes of sentinel lymph node biopsy and conventional procedure. The investigators perform a phase III, randomized controlled trial to determine whether pelvic lymphadenectomy can be replaced by sentinel lymph node biopsy in surgical treatment for patients with early-stage cervical cancer.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 1080 (estimated)
- First submitted
- 24 Dec 2015
- Start date
- 31 Dec 2015
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Cervical cancer
- NCT number
- NCT02642471
What you commit to
- Study type: Interventional
- Planned participants: 1080
- From 31 Dec 2015 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving other ways of anti-cancer therapy
Other illness
- The presence of uncontrolled life-threatening illness
- History of severe heart disease or deep venous thrombosis; 4) Presence or history of other malignant disease
Lab values
- With normal liver function test (ALT、AST\>2.5×ULN)
- With normal renal function test (Creatinine\>1.5×ULN)
- WBC\<4,000/mm3 or PLT\<100,000/mm
Other
- Investigator consider the patients can't finish the whole study
- The whole cervix has been occupied by tumor and there is no normal surface left for tracer injection
- Gestation or perinatal period
- Intention to fertility preservation.
Who the study is looking for
- Patients with newly histologically confirmed cervical carcinoma
- Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
- Original clinical stage must be FIGO (2018) stage IA1 (lymphovascular space involvement), IA2, IB1, IB2 and IIA1
- No suspected node should be found on imaging examination (RESIST 1.1)
- Age between 18-65
- Patients must give signed informed consent
- P.S status: 0-1
- Estimated survival time \> 3 months
- Tumor diameter ≤ 3 cm
Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.