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.
Overview
- Phase
- Phase 2
- Intervention
- Brachytherapy
- Conditions
- Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t
- Sponsor
- Instituto do Cancer do Estado de São Paulo
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Disease free survival
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Advanced carcinoma of uterine cervix histological confirmed.
- •Indication for definitive chemoradiation treatment;
- •Measurable disease by RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) criteria;
- •Age between 18 years old and 70 years old;
- •Adequate bone marrow and organ function defined by laboratory values;
- •Non evidence of disease in para-aortic lymph node;
Exclusion Criteria
- •Previous treatment with Chemotherapy or radiotherapy
- •Previous surgery for primary tumor;
- •Distant metastasis;
- •Performance status according to Eastern Cooperative Oncology Group greater than 2;
- •Peripheric neuropathy greater than grade 2 by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 3.0;
- •Significant Cardiac disease (history of and/or active disease);
- •Other treatment for cancer, including hormonotherapy;
- •Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements;
Arms & Interventions
Chemoradiotherapy
Cisplatin, radiotherapy and brachytherapy
Intervention: Brachytherapy
Chemo-induction
Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
Intervention: cisplatin
Chemo-induction
Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
Intervention: Gemcitabine
Chemo-induction
Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
Intervention: Radiotherapy
Chemo-induction
Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy
Intervention: Brachytherapy
Chemoradiotherapy
Cisplatin, radiotherapy and brachytherapy
Intervention: cisplatin
Chemoradiotherapy
Cisplatin, radiotherapy and brachytherapy
Intervention: Radiotherapy
Outcomes
Primary Outcomes
Disease free survival
Time Frame: From the randomization until the end of the treatment - up to 36 month.
Secondary Outcomes
- Locoregional disease control rate(36 month after the end of treatment.)
- Acute and chronic toxicity in both arms(From the randomization until the end of the treatment.)
- Overall survival(36 month after the end of the treatment.)
- Response rate(36 month after the end of the treatment.)