NCT01973101

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.

Phase II, Prospective, Randomized, 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.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-06-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2013-10-31
• Last updated: 2014-07-15

Locations

1 site across 1 country: Brazil