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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006309-17-LT
Enrollment
Unknown
Registered
2009-06-19
Start date
2009-11-19
Completion date
Unknown
Last updated
2014-10-07

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

Conditions

Locally advanced IIB-IIIB stages cervical cancer. MedDRA version: 9.1 Level: LLT Classification code 10008229 Term: Cervical cancer

Interventions

Trade Name: CISPLATIN-TEVA Product Name: CISPLATIN-TEVA Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: CISPLATIN CAS Number: 15663271 Concentration unit: mg/ml milligr

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

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 or= upper limit of normal (ULN); ALT and AST > or = 3x ULN. 3. Pregnancy or breast-feeding period; 4. Serious psychiatric disorders.

Design outcomes

Primary

MeasureTime frame
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); 2. To evaluate treatment safety.;Secondary Objective: 1. To evaluate the overall survival; 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.—

Countries

Lithuania

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026