Status:
UNKNOWN
A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pelvic or Para-aortic Node Involvement)
Lead Sponsor:
Sun Yat-sen University
Conditions:
Cervical Cancer
Adjuvant Chemotherapy
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief 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...
Detailed Description
1. Background Cervical Cancer is one of the most common malignant tumors of Chinese females. Women with evidence of para-aortic node involvement have a poor prognosis with a five-year survival rate of...
Eligibility Criteria
Inclusion
- Pathologically diagnosed cervical cancer;
- 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
- Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;
- Karnofsky Performance Scores ≥ 70;
Exclusion
- Patients with distant metastasis before or during radiotherapy
- Severe dysfunction of heart, lung, liver, kidney or hematopoietic system
- Severe neurological, mental or endocrine diseases
- History of other malignancies
- Those who are considered by the researchers unsuitable to participate -
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
432 Patients enrolled
Trial Details
Trial ID
NCT03468010
Start Date
March 1 2018
End Date
March 1 2025
Last Update
March 26 2018
Active Locations (8)
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1
Sun Yat-sen University Affiliated Foshan Hospital
Foshan, Guangdong, China
2
Hospital of of Guangdong Armed Police Corps
Guangzhou, Guangdong, China
3
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
4
The First affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China