Status:
UNKNOWN
Comparison of Different Subsequent Treatments After Radical Surgery
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Guangdong Provincial People's Hospital
First Affiliated Hospital, Sun Yat-Sen University
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief Summary
Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of the survival over years. The risk of recurrence after radical surgery has increased with positive lymph no...
Detailed Description
After radical surgery, patients with stage IB1 to IIA2 cervical cancer who had one or more following pathological factors were recruited: lymph node metastases (LNM), positive parametrium or margins (...
Eligibility Criteria
Inclusion
- Patients with newly histologically confirmed cervical carcinoma
- Original clinical stage must be Ib\~IIa (FIGO)
- Age between 18-65
- With the presence of these four factors after radical surgery:(1)positive lymph nodes,(2)positive parametria, or positive surgical margins,(3)positive lymphatic vascular space,(4)outer one-third invasion of the cervical stroma
- More than 3 months survival is to expect
- Patients must give signed informed consent
Exclusion
- The presence of uncontrolled life-threatening illness
- Receiving other ways of anti-cancer therapy
- Residual tumor which can not be removed in the surgery
- 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/mm3
- Receive the external pelvic irradiation before the surgery
Key Trial Info
Start Date :
February 25 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
1080 Patients enrolled
Trial Details
Trial ID
NCT00806117
Start Date
February 25 2008
End Date
December 31 2020
Last Update
July 30 2019
Active Locations (1)
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1
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060