Clinical trial NCT02880007: Dose Optimization in 3D Pulsed Dose Rate Brachytherapy for Patients With Locally Advanced Cervical Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Adenocarcinoma
Stage IB Cervical Cancer
Stage II Cervical Cancer
Stage III Cervical Cancer
Keywords: Pulsed dose-rate brachytherapy
3D dosimetry
Prospective Studies
Radiotherapy Dosage
Uterine Cervical Neoplasms/radiotherapy
Brachytherapy/methods
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Increase the local control rate
timeFrame: 24 months
Secondary outcomes:
measure: Maintain the cumulative rate grade III and IV complications below 6.5%
timeFrame: 24 months
measure: Relationship between the doses delivered to the target volume and local control
timeFrame: 24 months
measure: Relationship between the doses delivered to the critical organs and rate of grade III and IV complications
timeFrame: 24 months
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHU de Besançon
city: Bordeaux
country: France
facility: Institut Bergonié
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Lyon
country: France
facility: Centre Léon Bérard
city: Montpellier
country: France
facility: Centre Val d'Aurelle
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: Centre Claudius Regaud
city: Tours
country: France
facility: CHRU Tours - Hôpital Bretonneau
city: Vandoeuvre-les-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: PEIFFERT Didier
role: PRINCIPAL_INVESTIGATOR
References: