A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pelvic or Para-aortic Node Involvement)

• Status: Recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events and local recurrence rate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

Criteria

Inclusion Criteria:

1. Pathologically diagnosed cervical cancer;

2. pelvic or para-aortic lymph metastases, at least match one of following

• CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane

• pelvic or para-aortic lymph node shows necrosis or extra capsular spread

• PET/CT scan finds positive pelvic or para-aortic node lymph node

• biopsy confirms lymph metastase

3. Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;

4. Karnofsky Performance Scores ≥ 70;

Exclusion Criteria:

1. Patients with distant metastasis before or during radiotherapy

2. Severe dysfunction of heart, lung, liver, kidney or hematopoietic system

3. Severe neurological, mental or endocrine diseases

4. History of other malignancies

5. Those who are considered by the researchers unsuitable to participate -