Dose Optimization in 3D Pulsed Dose Rate Brachytherapy for Patients With Locally Advanced Cervical Cancer

Cervical Adenocarcinoma Clinical Trial

— TRIDICOL  

Official title:

A Prospective Open Label Phase II Study to Optimize the Dose in 3D Pulsed Dose Rate Brachytherapy in Patients With Locally Advanced Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02880007
• Other study ID #: 2010-A00235-34
• Status: Completed
• Phase: Phase 2
• Start date: June 6, 2011
• Est. completion date: July 1, 2019

Study information

• Verified date: March 2020
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective phase II trial study aims to optimize the increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy in treating patients with locally advanced cervical cancer.

Description:

• The causes of treatment failure and death in cervical cancer are still often linked to a local cancer progression

• The importance of local control for healing, than the cervix situation in the center of pelvis between bladder and rectum which are sensitive organs to irradiation justify the use of utero-vaginal brachytherapy

• This open label, multicenter, phase II study evaluates the benefit of increasing in dose to the target volume at high risk and the intermediate target volume in 3D Pulsed Dose Rate Brachytherapy in treating patients with locally advanced cervical cancer.

• Local control and tolerance are evaluated

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 1, 2019
• Est. primary completion date: February 10, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• primitive cervical cancer

• adenocarcinoma histologically advanced

• IB2, II and III stage

• curative treatment

• indication of utero-vaginal brachytherapy with external radiotherapy

• non-metastatic tumor and life expectancy > 6 months

• patient informed and follow possible

• performance status = 2

• unplanned surgery

• age = 18 years old

• ability to provide written informed consent before the start of any study specific procedures

Exclusion Criteria:

• primitive endometrial cancer

• other diseases

• carcinoma in situ and stages = B

• distant metastases

• history of pelvic irradiation or a first pelvic cancer

• contraindication to MRI

• history of subtotal or total hysterectomy

• pregnant or breast feeding females

• inability to support low dose rate continuous brachytherapy or pulsed flow

• person in emergencies

• person unable to give personally consent

• patient participating in another clinical research except in case of local recurrence or observational research

Related Conditions & MeSH terms

• Adenocarcinoma
• Cervical Adenocarcinoma
• Stage IB Cervical Cancer
• Stage II Cervical Cancer
• Stage III Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• External Beam Radiation Therapy
45 Gy pelvis / 25 fr
• PDR Brachytherapy
1 puls/hour ; 12 Gy / day

Drug:
• Cisplatin
increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy

Locations

Country	Name	City	State
France	CHU de Besançon	Besancon
France	Institut Bergonié	Bordeaux
France	Centre Georges-François Leclerc	Dijon
France	Centre Léon Bérard	Lyon
France	Centre Val d'Aurelle	Montpellier
France	Centre Paul Strauss	Strasbourg
France	Centre Claudius Regaud	Toulouse
France	CHRU Tours - Hôpital Bretonneau	Tours
France	Institut de Cancérologie de Lorraine	Vandoeuvre-les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase the local control rate	Increasing local control in two years (from 71.0% to 86.7%) will be achieved by increasing the dose to the target volume (CTV and CTV-HR-RI) measured dose volume histograms	24 months
Secondary	Maintain the cumulative rate grade III and IV complications below 6.5%		24 months
Secondary	Relationship between the doses delivered to the target volume and local control		24 months
Secondary	Relationship between the doses delivered to the critical organs and rate of grade III and IV complications		24 months