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Trial Title:
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.
NCT ID:
NCT01973101
Condition:
Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t
Conditions: Official terms:
Carcinoma
Cisplatin
Gemcitabine
Conditions: Keywords:
Advanced carcinomas of uterine cervix
Chemoradiation
Chemo-induction
Cisplatin
Gemcitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
50 mg/m2 - Day 1
Arm group label:
Chemo-induction
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine 1000mg/m2 on day 1 and day 8.
Arm group label:
Chemo-induction
Intervention type:
Drug
Intervention name:
cisplatin
Description:
Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.
Arm group label:
Chemo-induction
Arm group label:
Chemoradiotherapy
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
45 Gy
Arm group label:
Chemo-induction
Arm group label:
Chemoradiotherapy
Intervention type:
Radiation
Intervention name:
Brachytherapy
Description:
80 Gy
Arm group label:
Chemo-induction
Arm group label:
Chemoradiotherapy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Advanced carcinoma of uterine cervix histological confirmed.
2. Indication for definitive chemoradiation treatment;
3. Measurable disease by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)
criteria;
4. Age between 18 years old and 70 years old;
5. Adequate bone marrow and organ function defined by laboratory values;
6. Non evidence of disease in para-aortic lymph node;
Exclusion Criteria:
1. Previous treatment with Chemotherapy or radiotherapy
2. Previous surgery for primary tumor;
3. Distant metastasis;
4. Performance status according to Eastern Cooperative Oncology Group greater than 2;
5. Peripheric neuropathy greater than grade 2 by National Cancer Institute Common
Toxicity Criteria for Adverse Events (NCI-CTCAE) version 3.0;
6. Significant Cardiac disease (history of and/or active disease);
7. Other treatment for cancer, including hormonotherapy;
8. Psychiatric or addictive disorders or other conditions that, in the opinion of the
investigator, would preclude the patient from meeting the study requirements;
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
ICESP
Address:
City:
São Paulo
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Maria Del Pilar Estevez Diz, MD
Phone:
55 11 3893-2000
Email:
pesquisa.clinica@icesp.org.br
Start date:
June 2012
Completion date:
April 2017
Lead sponsor:
Agency:
Instituto do Cancer do Estado de São Paulo
Agency class:
Other
Source:
Instituto do Cancer do Estado de São Paulo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01973101
