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

Institut de Cancérologie de Lorraine

Status and phase

Completed

Phase 2

Conditions

Stage III Cervical Cancer

Cervical Adenocarcinoma

Stage IB Cervical Cancer

Stage II Cervical Cancer

Treatments

Drug: Cisplatin

Radiation: External Beam Radiation Therapy

Radiation: PDR Brachytherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02880007

2010-A00235-34

Details and patient eligibility

About

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.

Full 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

Enrollment

48 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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