NCT02880007

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Institut de Cancérologie de Lorraine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
RADIATION	External Beam Radiation Therapy	45 Gy pelvis / 25 fr
RADIATION	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

Timeline

• Start date: 2011-06-06
• Primary completion: 2014-02-10
• Completion: 2019-07-01
• First posted: 2016-08-26
• Last updated: 2020-03-10

Locations

9 sites across 1 country: France