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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01650987
First Posted: July 26, 2012
Last Update Posted: August 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Oscar Lambret
  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 ]
    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 ]
    Compare the various scales of toxicity

  • Study the sexual behavior modifications [ Time Frame: up to 3 years ]
    According to a questionnaire and a personal discussion

  • Specify correlation modifications of sexual behavior [ Time Frame: up to 3 years ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: July 20, 2012
First Posted: July 26, 2012
Last Update Posted: August 8, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
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