Retrospective Analysis of Cervical Cancer Treated With Concomitant Chemoradiotherapy With or Without Closure Surgery

Cervix Cancer Clinical Trial

— COL UTERIN  

Official title:

Retrospective Analysis of Cervical Cancer Treated With Concomitant Chemoradiotherapy With or Without Closure Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469908
• Other study ID #: COL UTERIN-IPC 2017-032
• Status: Completed
• First received: March 5, 2018
• Last updated: March 12, 2018
• Start date: January 1, 2012
• Est. completion date: December 31, 2016

Study information

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

Clinical Trial Summary

To retrospectively evaluate the local and remote control, toxicity and survival taking into account the dosimetric data of concomitant radiochemotherapy plus brachytherapy +/- closure surgery of cervical cancers.

Description:

Evaluation of local control, defined as the absence of recurrence on the cervix, vagina and parameters (centro-pelvic).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cervical cancer and FIGO stage I-IVA

Exclusion Criteria:

• No regular monitoring at the site

Related Conditions & MeSH terms

• Cervix Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Chemotherapy
Chemotherapy

Radiation:
• Radiotherapy
Radiotherapy

Procedure:
• Closure surgery
Closure surgery

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)

Chargari C, Mazeron R, Escande A, Maroun P, Dumas I, Martinetti F, Tafo-Guemnie A, Deutsch E, Morice P, Haie-Meder C. Image-guided adaptive brachytherapy in cervical cancer: Patterns of relapse by brachytherapy planning parameters. Brachytherapy. 2016 Jul-Aug;15(4):456-62. doi: 10.1016/j.brachy.2016.04.006. Epub 2016 May 12. — View Citation

Sturdza A, Pötter R, Fokdal LU, Haie-Meder C, Tan LT, Mazeron R, Petric P, Šegedin B, Jurgenliemk-Schulz IM, Nomden C, Gillham C, McArdle O, Van Limbergen E, Janssen H, Hoskin P, Lowe G, Tharavichitkul E, Villafranca E, Mahantshetty U, Georg P, Kirchheiner K, Kirisits C, Tanderup K, Lindegaard JC. Image guided brachytherapy in locally advanced cervical cancer: Improved pelvic control and survival in RetroEMBRACE, a multicenter cohort study. Radiother Oncol. 2016 Sep;120(3):428-433. doi: 10.1016/j.radonc.2016.03.011. Epub 2016 Apr 29. — View Citation

Tanderup K, Fokdal LU, Sturdza A, Haie-Meder C, Mazeron R, van Limbergen E, Jürgenliemk-Schulz I, Petric P, Hoskin P, Dörr W, Bentzen SM, Kirisits C, Lindegaard JC, Pötter R. Effect of tumor dose, volume and overall treatment time on local control after radiochemotherapy including MRI guided brachytherapy of locally advanced cervical cancer. Radiother Oncol. 2016 Sep;120(3):441-446. doi: 10.1016/j.radonc.2016.05.014. Epub 2016 Jun 24. Erratum in: Radiother Oncol. 2017 Apr;123(1):169. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control	Local control defined as the absence of recurrence on the cervix, vagina, para-vagina and parameters (centro-pelvic).	60 months
Secondary	Pelvic control	Pelvic control defined as the absence of pelvic lymph node recurrence,	60 months
Secondary	Overall Survival	Overall Survival, defined as the time between the date of diagnosis and the date of death or the latest news	60 months
Secondary	Toxicities (CTCAE v4)	Toxicities (CTCAE v4)	60 months
Secondary	Detimetric brachytherapy data	Detimetric brachytherapy data	60 months
Secondary	Histo-pathological sterilization	Impact of dosimetric data on histopathological sterilization, toxicity and local control	60 months
Secondary	Ganglion sterilization	Impact of dosimetric data on ganglion sterilization, toxicity and local control	60 months
Secondary	Diagnosis post RTCT from MRI, radiography or PET-scan	Evaluate the concordance between post-RTCT MRI and radiography diagnoses, and between PET-scan and MRI.	60 months