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OpenTrials
Completed

NCT Number: NCT03238261

Chemotherapy / Radiotherapy in Uterine Cervical Neoplasms

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

1. Describe and compare the demographic and clinical characteristics of both groups. 2. Compare the three year survival rate in both groups. 3. Compare the response to treatment in terms of locoregional control of the disease. 4. Compare the appearance of severe and non severe adverse events directly related to the treatment in both intervention groups.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chemotherapy and concomitant radiotherapy

Radiation

Radiotherapy (teletherapy + high or low rate brachytherapy)

Primary outcomes

  1. Survival rate

    Time frame: 3 years

    the disease free survival rate

Secondary outcomes

  1. The response to treatment in terms of locoregional control of the disease

    Time frame: 3 years

    efficacy

  2. Events adverse

    Time frame: 3 years

    • Compare the appearance of severe and non severe adverse events directly related to the treatment in both intervention groups.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Cancerologia, Columbia

Other Gov

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2016
First posted
Aug 3, 2017
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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