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Clinical Trials in China / NCT02642471
Active, not recruiting Not applicable

Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early-stage Cervical Cancer (PHENIX/CSEM 010)

NCT02642471 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Not applicable
Started
2015-12-31
Last updated
2024-12-16

Condition(s) studied

Cervical CancerSurgeryQuality of Life

Investigational drug(s) / intervention(s)

no systematic pelvic lymphadenectomy

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)

Trial sites (1)

FacilityCityRegionStatus
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center Guangzhou Guangdong

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Official registry record

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.

View NCT02642471 on ClinicalTrials.gov ↗ ← All trials in China