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