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A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Primary Chemoradiation for Locally Advanced Cervical Cancer


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

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Trial Information

A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Primary Chemoradiation for Locally Advanced Cervical Cancer


Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks)
following primary chemoradiation (3 cycles per 3 weeks) for locally advanced 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 three cycles of concurrent chemoradiation therapy with
paclitaxel and carboplatin for non-small cell type cervical cancer stage IB2, bulky
size (>4cm) IIA,IIB-IVA

- 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 CTCAE 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-2

NCT ID:

NCT00591656

Start Date:

November 2007

Completion Date:

November 2012

Related Keywords:

  • Cervical Cancer
  • Uterine Cervical Neoplasms

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