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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Patients Diagnosed With Advanced Carcinoma of Uterine Cervix t

Intervention / Treatment
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* Drug: Cisplatin
* Drug: Gemcitabine
* Drug: cisplatin
* Radiation: Radiotherapy
* Radiation: Brachytherapy


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemo-induction<br>Cisplatin plus Gemcitabine for 3 cycles followed by Cisplatin, radiotherapy and brachytherapy | Drug: Cisplatin<br>* 50 mg/m2 - Day 1<br>Drug: Gemcitabine<br>* Gemcitabine 1000mg/m2 on day 1 and day 8.<br>Drug: cisplatin<br>* Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.<br>Radiation: Radiotherapy<br>* 45 Gy<br>Radiation: Brachytherapy<br>* 80 Gy<br>|
| Active Comparator: Chemoradiotherapy<br>Cisplatin, radiotherapy and brachytherapy | Drug: cisplatin<br>* Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.<br>Radiation: Radiotherapy<br>* 45 Gy<br>Radiation: Brachytherapy<br>* 80 Gy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | From the randomization until the end of the treatment - up to 36 month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 36 month after the end of the treatment. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced carcinomas of uterine cervix, Chemoradiation, Chemo-induction, Cisplatin, Gemcitabine