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Systemic Consolidation Therapy After Primary Chemoradiation Therapy for Locally Advanced Cervical Cancer

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00591656
Enrollment
69
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 primary chemoradiation for locally advanced cervical cancer.

Detailed description

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.

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026