no systematic pelvic lymphadenectomy: systematic pelvic lymphadenectomy is omitted in surgical treatment
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* The presence of uncontrolled life-threatening illness
* Receiving other ways of anti-cancer therapy
* Investigator consider the patients can't finish the whole study
* 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
* The whole cervix has been occupied by tumor and there is no normal surface left for tracer injection
* History of severe heart disease or deep venous thrombosis; 4) Presence or history of other malignant disease
* Gestation or perinatal period
* Intention to fertility preservation.
Primary outcome measure(s)
Disease free survival in PHENIX-I — 3 years
Disease free survival in PHENIX-II — 2 years
Trial sites (1)
Facility
City
Region
Status
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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