Significance of prognostic and predictive factors for the efficacy and safety of neoadjuvant chemotherapy in combination with chemoradiation administered in patients with locally advanced cervical cancer.

KONSTANTINAS POVILAS VALUCKAS, INSTITUTE OF ONCOLOGY OF VILNIUS UNIVERSITY0 sitesJune 19, 2009

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: ocally advanced IIB-IIIB stages cervical cancer.
Sponsor: KONSTANTINAS POVILAS VALUCKAS, INSTITUTE OF ONCOLOGY OF VILNIUS UNIVERSITY
Status: Active, not recruiting
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

June 19, 2009

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

KONSTANTINAS POVILAS VALUCKAS, INSTITUTE OF ONCOLOGY OF VILNIUS UNIVERSITY

•1\. Women with locally advanced non\-operable IIB\-IIIB stages cervical cancer.
•2\. Subjects previously received no treatment for cervical cancer.
•3\. Age 18\-60 years.
•4\. ECOG \= 0, ECOG \= 1\.
•5\. Written informed consent form.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

•1\. Unstable angina pectoris or myocardial infarction within 6 months prior to enrolment; life threatening cardiac arrhythmia and not finished supportive therapy; known pulmonary hypertension.
•2\. Non\-adequate laboratory analysis values:
•ANC\< 1,5x10\*/l; Plt \< or \= 100x10\*/l; Hb \< or\= 90 g/l;
•serum creatinine \> or\= upper limit of normal (ULN); ALT and AST \> or \= 3x ULN.
•3\. Pregnancy or breast\-feeding period;
•4\. Serious psychiatric disorders.