Know Cancer

or
forgot password

A Multicenter Trial of Benefits of Adding Chemotherapy as the Adjuvant Post-surgery Therapy for Cervical Cancer With Adverse Pathological Prognostic Factors


Phase 3
18 Years
65 Years
Open (Enrolling)
Female
Cervical Cancer

Thank you

Trial Information

A Multicenter Trial of Benefits of Adding Chemotherapy as the Adjuvant Post-surgery Therapy for Cervical Cancer With Adverse Pathological Prognostic Factors


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

distant metastasis free survival,disease free survival

Outcome Time Frame:

5-Yr

Safety Issue:

Yes

Principal Investigator

Jihong Liu, Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Ministry of Health

Study ID:

2008049

NCT ID:

NCT00806117

Start Date:

February 2008

Completion Date:

December 2017

Related Keywords:

  • Cervical Cancer
  • Cervical cancer
  • Concurrent chemoradiation
  • Randomized controlled clinical trials
  • Uterine Cervical Neoplasms

Name

Location