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Non-comparative Study of Treatment With Induction Chemotherapy With Cisplatin and Gemcitabine Followed by Chemoradiation or Definitive Chemoradiation in Invasive Locally Advanced Carcinomas of Uterine Cervix.

NCT01973101 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-07-15

No results posted yet for this study

Summary

The purpose of this phase II study is to determine the survival free disease of patients diagnosed with invasive locally advanced carcinomas of uterine cervix treated with induction chemotherapy with cisplatin and gemcitabine followed by chemoradiation and definitive chemoradiation.

Conditions

  • Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t

Interventions

DRUG

Cisplatin

50 mg/m2 - Day 1

DRUG

Gemcitabine

Gemcitabine 1000mg/m2 on day 1 and day 8.

DRUG

cisplatin

Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.

RADIATION

Radiotherapy

45 Gy

RADIATION

Brachytherapy

80 Gy

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • Maria Del Pilar Estevez Diz, MD · Instituto do Cancer do Estado de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2017-04-30
Completion
2017-04-30

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 NCT01973101 on ClinicalTrials.gov