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A randomized controlled study of radical surgery with or without para-aortic lymph node dissection in early cervical cancer patients with clinically negative para-aortic lymph nodes

A randomized controlled study of radical surgery with or without para-aortic lymph node dissection in early cervical cancer patients with clinically negative para-aortic lymph nodes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032837
Enrollment
Unknown
Registered
2020-05-12
Start date
2020-08-16
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Interventions

control group:radical surgery
experimental group:radical surgery and para-aortic lymphadenectomy

Sponsors

Fudan University Shanghai Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of early cervical cancer (stage IB2, IB3, IIA1, or IIA2); 2. The pathology of cervical biopsy or LEEP is cervical squamous cell carcinoma, cervical adenosquamous cell carcinoma or cervical adenocarcinoma; 3. Aged 18 - 70, ECOG performance status 0 - 2; 4. Without neoadjuvant chemotherapy or radiotherapy before operation; 5. Para-aortic lymph nodes are negative before operation by CT, MRI and/or PET-CT; 6. Para-aortic lymph nodes are negative during Intraoperative exploration; 7. Adequate liver and renal function; 8. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Can't accept operation due to various contraindications; 2. Suffering from other malignant tumors or other serious medical and surgical complications; 3. Extra-cervical metastasis detected by CT, MRI and/or PET-CT; 4. Unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons; 5. Participated in other clinical trials; 6. Drug addiction, chronic alcoholism or AIDS.

Design outcomes

Primary

MeasureTime frame
OS;PFS;

Secondary

MeasureTime frame
Incidence of surgical complications;Metastasis rate of para-aortic lymph nodes;Quality of life;

Countries

China

Contacts

Public ContactWu Xiaohua

Fudan University Shanghai Cancer Center

docwuxh@yahoo.com+86 021 64175590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026