Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function (SEXUTOX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01650987
First received: July 20, 2012
Last updated: August 5, 2016
Last verified: August 2016
  Purpose
Evaluate the toxicities of cervix and corpus uteri carcinomas treatment

Condition
Corpus Uteri Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of Toxicities of Cervix and Corpus Uteri Carcinomas Treatment and Evaluation of Impact on Sexual Function

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Toxicities including on sexual function [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    According to Lent-Soma, NCICTC-AE v3.0, Franco-Italian Glossary


Secondary Outcome Measures:
  • Compare the various scales of toxicity [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Compare the various scales of toxicity

  • Study the sexual behavior modifications [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    According to a questionnaire and a personal discussion

  • Specify correlation modifications of sexual behavior [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    Specify the existence of a correlation between toxicities included modifications and sexual behavior modifications


Enrollment: 72
Study Start Date: May 2009
Study Completion Date: December 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Col 1
Patient with uterus adenocarcinoma, treated by surgery, then surveillance without complementary treatment
Col 2
Patient with uterus adenocarcinoma, treated by surgery then adjuvant radiotherapy
Col 3
patient with uterus adenocarcinoma, treated by surgery then curietherapy of vaginal dome
Endometrial 4
patient with cervix carcinoma stage IA2 to IIB, treated by surgery only
endometrial 5
patient with cervix carcinoma stage IA2 to IIB, treated by surgery then curietherapy
endometrial 6
patient with cervix carcinoma stage IA2 to IIB, treated by surgery then curietherapy and radiotherapy

Detailed Description:
Evaluate the toxicities of cervix and corpus uteri carcinomas treatment on sexual function after treatment (radiotherapy and/or surgery)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with a corpus uteri carcinoma, without metastasis.
Criteria
  • Inclusion Criteria:
  • Patients whose treatment is provided to Centre Oscar Lambret
  • With a corpus uteri adenocarcinoma, no metastatic, treated by:
  • Surgery and observation without complementary treatment
  • Or surgery and adjuvant radiotherapy
  • Or Surgery and curietherapy of vaginal dome
  • With a cervix carcinoma, stade IA2 to IIB proximal, treated by :
  • External radiochemotherapy and curietherapy
  • Or only surgery
  • Or pre-surgical curietherapy and surgery
  • Age > 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01650987

Locations
France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
Study Director: Philippe NICKERS, MD Oscar Lambret Center
  More Information

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01650987     History of Changes
Other Study ID Numbers: SEXUTOX 
Study First Received: July 20, 2012
Last Updated: August 5, 2016
Health Authority: France: The Commission nationale de l’informatique et des libertés
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Centre Oscar Lambret:
carcinoma
uterus
Not metastatic

Additional relevant MeSH terms:
Carcinoma
Uterine Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 25, 2016