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NCT03470831 Clinical Trial

Modeling Normal Tissue Complication Probability (NTCP) Vagina in Cervical Cancer

Cervical Cancer Treated With Pelvic Radiotherapy Clinical Trial

— NTCP  

Official title:
Modeling Normal Tissue Complication Probability (NTCP) Vagina in Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03470831
Other study ID # NTCP-IPC 2017-009
Secondary ID
Status Completed
Phase
First received March 13, 2018
Last updated March 13, 2018
Start date January 1, 2003
Est. completion date March 22, 2017

Study information
Verified date March 2018
Source Institut Paoli-Calmettes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. Determining the best predictors of vaginal toxicity of radiotherapy treatment in cervical cancer through the construction of a logistic regression model.

2. Modeling vaginal NTCP according to the Lyman model.

Description:

The vaginal toxicity induced by the radiotherapy treatments is very little studied, among all the constraints of doses on the organs at risk, none concerns the vagina. This lack of recommendation on this organ originates from an oversight (probably due to lack of interest at the time) in the design of models describing the probabilities of toxicity by volume and dose received.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date March 22, 2017
Est. primary completion date December 31, 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All patients> 18 years treated with pelvic radiotherapy at the IPC since January 2003

Exclusion Criteria:

- Total pelvectomy unrelated to toxicity

- lack of 3D dosimetry.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Report of G3 vaginal toxicity according to CTAE 4.0.
Report of G3 vaginal toxicity according to CTAE 4.0.

Locations
Country Name City State
France Institut Paoli Calmettes Marseille Bouches Du Rhone

Sponsors (1)
Lead Sponsor Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

References & Publications (3)

Burman C, Kutcher GJ, Emami B, Goitein M. Fitting of normal tissue tolerance data to an analytic function. Int J Radiat Oncol Biol Phys. 1991 May 15;21(1):123-35. — View Citation

El Naqa I, Bradley J, Blanco AI, Lindsay PE, Vicic M, Hope A, Deasy JO. Multivariable modeling of radiotherapy outcomes, including dose-volume and clinical factors. Int J Radiat Oncol Biol Phys. 2006 Mar 15;64(4):1275-86. — View Citation

Magné N, Chargari C, Pointreau Y, Haie-Meder C. [Normal tissue tolerance to external beam radiation therapy: the vagina]. Cancer Radiother. 2010 Jul;14(4-5):369-72. doi: 10.1016/j.canrad.2010.02.003. Epub 2010 Apr 24. French. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Estimate of Normal Tissue Complication Probability (NTCP) Vagina G3 vaginal toxicity according to CTAE 4.0. 28 days
Secondary Determining the best predictors of vaginal toxicity of radiotherapy treatment in cervical cancer through the construction of a logistic regression model other grades of vaginal toxicity. 28 days