Chemotherapy / Radiotherapy in Uterine Cervical Neoplasms

Study Overview
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Brief Summary
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Compare the use of radiotherapy and concomitant chemotherapy, with the single use of radiotherapy in the treatment of patients with stage IIIB uterine cancer, having as an outcome the three year survival rate, the disease free survival rate, the locoregional control of the disease and the security of the treatments provided. Specific objectives Describe and compare the demographic and clinical characteristics of both groups. Compare the three year survival rate in both groups. Compare the response to treatment in terms of locoregional control of the disease. Compare the appearance of severe and non severe adverse events directly related to the treatment in both intervention groups.

Detailed Description
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Inclusion criteria Women between 18 and 80 years old, diagnosed with uterine squamous cell cancer or stage IIIB adenocarcinoma (FIGO) with ECOG equal 1 or less and a Karnofsky equal or more than 70%. Exclusion criteria Having a concomitant or previous neoplasia, except for patients with skin tumors not associated to melanomas, platelet count under 100.000, hemoglobin levels of 10 gr/dl or above before starting the first radiotherapy session, patients with recurrent invasive uterine carcinoma, patients with compromised para aortic lymph nodes, patients with active and non controlled pelvic infection by the beginning of the treatment, creatinine depuration less than 45 ml/min confirmed with glomerular filtration rate less than 45 ml/min, neutrophils count less than 1,500/ml, and pregnant or nursing woman. Analysis The descriptive statistical analysis will be made with proportions for the categorical variables, and for numerical variables will be made with averages, medians, standard deviations and ranges. The comparison between categorical variables will be made with square Ji proof or exact Fisher's proof when square Ji proof doesn't meet the criteria. The comparison among continuous variables with normal distribution will be established with T student distribution proof or ANOVA, and Mann-Whitnew or Kruskall proofs will be used for variables that doesn't have this type of distribution. For the three survival rate, the Kaplan Meier method will be applied, and the survival curves will be compared with the logarithmic range proof. The Cox proportional hazard model is going to be used for the multivariate analysis and to stablish reasons. Additionally 5 interim analysis will be made.

Official Title
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CHEMOTHERAPY AND CONCOMITANT RADIOTHERAPY VS. RADIOTHERAPY IN THE TREATMENT OF PATIENTS WITH STAGE IIIB UTERINE CANCER

Conditions
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Uterine Cervical Neoplasms

Intervention / Treatment
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* Radiation: Chemotherapy and concomitant radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between 18 and 80 years old, diagnosed with uterine squamous cell cancer or stage IIIB adenocarcinoma (FIGO) with ECOG equal 1 or less and a Karnofsky equal or more than 70%. Exclusion Criteria: Having a concomitant or previous neoplasia, except for patients with skin tumors not associated to melanomas, platelet count under 100.000, hemoglobin levels of 10 gr/dl or above before starting the first radiotherapy session, patients with recurrent invasive uterine carcinoma, patients with compromised para aortic lymph nodes, patients with active and non controlled pelvic infection by the beginning of the treatment, creatinine depuration less than 45 ml/min confirmed with glomerular filtration rate less than 45 ml/min, neutrophils count less than 1,500/ml, and pregnant or nursing woman.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy and concomitant radiotherapy<br> | Radiation: Chemotherapy and concomitant radiotherapy<br>* Radiotherapy (teletherapy + high or low rate brachytherapy)<br>|
| Active Comparator: Radiotherapy<br> | Radiation: Chemotherapy and concomitant radiotherapy<br>* Radiotherapy (teletherapy + high or low rate brachytherapy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | the disease free survival rate | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The response to treatment in terms of locoregional control of the disease | efficacy | 3 years | 
| Events adverse | 4. Compare the appearance of severe and non severe adverse events directly related to the treatment in both intervention groups. | 3 years |