Status:
COMPLETED
Neoadjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients
Lead Sponsor:
Professor Fernando Figueira Integral Medicine Institute
Collaborating Sponsors:
Instituto Nacional de Cancer, Brazil
Conditions:
Cancer of Cervix
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief 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...
Detailed Description
The study has been developed and executed at Medicina Integral Prof. Fernando Figueira Institute - IMIP since September/2013. The primary objective is to evaluate the safety of neoadjuvant chemotherap...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02309658
Start Date
September 1 2013
End Date
October 1 2015
Last Update
October 16 2015
Active Locations (1)
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1
Instituto de Medicina Integral Fernando Figueira
Recife, Pernambuco, Brazil, 50070550