Systemic Consolidation Therapy After Chemoradiation Therapy Following Operation for High Risk Early Stage Cervical Cancer

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00592059

Enrollment

Registered

2008-01-11

Start date

2007-11-30

Completion date

2012-11-30

Last updated

2008-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer

Brief summary

The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following radical hysterectomy and adjuvant chemoradiation for high risk early stage cervical cancer.

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 75 Years

Healthy volunteers

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

Countries

South Korea

Contacts

Primary ContactSeung Su Han, MD

hsuu3415@snu.ac.kr082-02-2072-2821

Outcome results