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.

Conditions: ocally advanced IIB-IIIB stages cervical cancer.
MedDRA version: 9.1Level: LLTClassification code 10008229Term: Cervical cancer

Registration Number: EUCTR2008-006309-17-LT

Lead Sponsor: KONSTANTINAS POVILAS VALUCKAS, INSTITUTE OF ONCOLOGY OF VILNIUS UNIVERSITY

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

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
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1. To evaluate the efficacy of treatment with neoadjuvant cisplatin+gemcitabine based chemotherapy and with concurrent cisplatin+gemcitabine+radiotherapy in locally advanced cervical cancer (defined as response to treatment and progression free survival);<br>2. To evaluate treatment safety.;Secondary Objective: 1. To evaluate the overall survival;<br>2. To assess significance of prognostic and predictive factors for disease prognosis, response to the neoadjuvant chemotherapy in combination with chemoradiation administered in patients with locally advanced cervical cancer, to assess the relationship of these factors and the stage of disease, hystological type and malignancy.;Primary end point(s): To evaluatethe efficacy and safety of the treatment.

Secondary Outcome Measures