Chemotherapy / Radiotherapy in Uterine Cervical Neoplasms

Uterine Cervical Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238261
• Other study ID #: C41030310-023
• Status: Completed
• Phase: N/A
• First received: July 31, 2017
• Last updated: August 9, 2017
• Start date: August 1, 2007
• Est. completion date: May 1, 2016

Study information

• Verified date: July 2017
• Source: Instituto Nacional de Cancerologia, Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: May 1, 2016
• Est. primary completion date: February 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Chemotherapy and concomitant radiotherapy
Radiotherapy (teletherapy + high or low rate brachytherapy)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Cancerologia, Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate	the disease free survival rate	3 years
Secondary	The response to treatment in terms of locoregional control of the disease	efficacy	3 years
Secondary	Events adverse	4. Compare the appearance of severe and non severe adverse events directly related to the treatment in both intervention groups.	3 years