Clinical trial · Interventional
Selective Pelvic Lymphadenectomy for IB-IIA Cervical Cancer
Study on Selective Pelvic Lymphadenectomy for IB-IIA Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Test name: Study on selective pelvic lymphadenectomy for IB - IIA cervical cancer Researcher: Wu Xiaohua Research Center: Fudan University Shanghai Cancer Center The trial is expected to last for 3 years Test objectives： The primary goal：The overall therapeutic effect of patients with selective lymphadenectomy was not inferior to patients with systemic pelvic lymphadenectomy. Secondary goal: Selective lymphadenectomy can reduce the incidence and severity of postoperative lower limb lymphedema. The study was designed for prospective, randomized, controlled clinical trials. The number of subjects: 200 cases. Research groupings Selective pelvic lymphadenectomy group and The control group was treated with systematic pelvic lymph node dissection group. Follow-up time: 3 years Sample size: 200 cases End of the trial: Primary end-poin:t three-year survival (overall survival, progression-free survival) Secondary end point: lower limb lymph node lymphedema
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymph nodes debulking surgery. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- description
- IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and systematic pelvic lymphadenectomy
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- IB-IIA Cervical Cancer Patients with positive lymph node metastasis confirmed by intraoperative frozen pathological examination who will undergo radical hysterectomy and selective enlarged lymph node dissection.
- interventionNames
- Procedure: Lymph nodes debulking surgery.
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- 3 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. histology confirmed as cervical adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma. 2. histological grading of cervical cancer is 1, 2, 3 or not. 3. patients in the group must have no reproductive function requirements. 4. Patients must be ≥ 18 years of age. 5. preoperative: pelvic CT / MR or PET / CT suggest pelvic lymph node enlargement. Intraoperative: Patients with pelvic lymph node metastasis confirmed by freezing. 6. Signed informed consent. 7. Surgery should be completed within 4 weeks after the first diagnosis. 8. patients can receive treatment and follow-up. Exclusion Criteria: 1. abdominal CT, PET / CT suggest that patients with para aortic lymph node metastasis. 2. other history of the tumor, but does not include: received appropriate treatment of non-melanoma skin cancer, has been cured of other solid tumors, has been cured or non Hodgkin's lymphoma and Hodgkin's lymphoma 5 years without recurrence. 3. Those who have received or will receive neoadjuvant chemotherapy. 4. patients with preoperative limb lymphedema or lower extremity venous and lymphatic reflux disorders. 5. pregnant women
References
Publications (0)
Data not yet available