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A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Radical Hysterectomy and Adjuvant Chemoradiation for High Risk Early Stage Cervical Cancer


N/A
20 Years
75 Years
Open (Enrolling)
Female
Cervical Cancer

Thank you

Trial Information

A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Radical Hysterectomy and Adjuvant Chemoradiation for High Risk Early Stage Cervical Cancer


Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks)
following radical hysterectomy and adjuvant chemoradiation (3 cycles per 3 weeks) for high
risk early stage cervical cancer will elevate the therapeutic efficacy by removing the
microscopic metastatic lesions which could not be identified by naked eye and diagnostic
imaging tests.


Inclusion Criteria:



- patients who underwent radical hysterectomy for cervical cancer stage IB-IIA

- Patients who had at least one of the following risk factors in pathologic results;
lymph node metastasis, positive residual resection margin, parametrial invasion

- above 20 years

- GOG performance status 0-2

- Informed consent

- Platelet>100K, Hb> 10.0 g/dl, ANC>1500/mm3, Cr <1.25*upper normal limit,
bilirubin<1.5mg/dl, AST & ALT<*3 upper normal limit

- Expected life > 6 months

Exclusion Criteria:

- Peripheral neurotoxicity > NCI grade 2

- Sever infection

- Previous history with chemotherapy or radiation therapy

- Pleural effusion, pericardial effusion, and ascites which could cause dyspnea > NCI
grade 2

- Paraaortic lymph node metastasis

- Allergy with platinum

- Previous history of atrial or ventricular arrhythmia or congestive heart failure

- Uncontrolled infection, diabetes mellitus, hypertension, ischemic heart disease,
myocardiac infarct within 6 months

- Severe disease such as acute or chronic renal failure and acute cerebral infarct,
cerebral hemorrhage, recurrent hepatitis, liver cirrhosis, unknown fever above 39
degrees centigrade

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Jae Weon Kim, Professor

Investigator Role:

Study Director

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

Sece-1

NCT ID:

NCT00592059

Start Date:

November 2007

Completion Date:

November 2012

Related Keywords:

  • Cervical Cancer
  • Uterine Cervical Neoplasms

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