Neoadjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The propose of this study is to determine if neoadjuvant chemotherapy followed by chemoradiation is safe and effective in locally advanced cervical cancer patients. Moreover, the study would determine if there is any association between hENT1 expression and response rate to gemcitabine.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Professor Fernando Figueira Integral Medicine Institute
• Collaborator: Instituto Nacional de Cancer, Brazil
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Histological confirmed diagnostic of cervical carcinoma

• International Federation of Gynecology and Obstetrics (FIGO) stage Ib2 (>4cm) to IVa

• Performance status 0-2 (ECOG scale)

• Hemoglobin >10g/dl , neutrophil > 1500 /mm3, platelet >100.000/mm3

• Creatinine < 1,5 mg/dl

• Bilirubin total <1,6 mg/dl and liver enzymes (AST e ALT) < 2x (upper limit of normal)

• Informed consent.

Exclusion Criteria:

• Cervical tumors with adenocarcinoma, adenosquamous and small cell adenocarcinoma histology

• Distant metastasis including paraortic nodes

• Pregnancy and breast-feeding

• Previous chemotherapy, radiotherapy or uterine surgery

• Relevant co-morbidity which prevent chemotherapy use

• Previous neoplasia, except non-melanoma skin cancer