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Neoadjuvant Chemotherapy in Locally Advanced Cervical Cancer Patients

NCT02309658 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-10-16

No results posted yet for this study

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.

Conditions

  • Cancer of Cervix

Interventions

DRUG

gemcitabine

Patients received intravenous 500-1000 ml normal saline and antiemetic medication before chemotherapy. Treatment consisted of intravenous gemcitabine at a dose of 1000 mg/m2 diluted in 500 ml of normal saline administered over 30 minutes mg/m2 diluted in 500 ml of normal saline administered over 30 minutes on days 1 and 8, followed by cisplatin 35 mg/m2 administered over 2 hours on day 1 and 8.

DRUG

cisplatin

35 mg/m2 administered over 2 hours on day 1 and 8.

RADIATION

chemoradiation

external beam radiotherapy concomitant with weekly cisplatin 40mg/m2

Sponsors & Collaborators

  • Instituto Nacional de Cancer, Brazil

    collaborator OTHER_GOV

  • Professor Fernando Figueira Integral Medicine Institute

    lead OTHER

Principal Investigators

  • Carla Rameri A. de Azevedo, MD · IMIP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02309658 on ClinicalTrials.gov