Effect of Bladder Distension on Dosimetry in Brachytherapy of Cervical Cancer (VESICOL)

Institut de Cancérologie de Lorraine

Status: Completed

Conditions: Cervical Cancer

Treatments: Other: brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02865837

2015-A00923-46

Details and patient eligibility

About

The purpose of this study is to compare, for each patient, dosimetry of organs at risk (bladder, rectum, sigmoid, small bowel) in two bladder distension procedures (emptied by a urinary catheter or filled with 120cc) during PDR 3D image-guided brachytherapy of cervical cancer.

Enrollment: 22 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > or = 18 years old

• with a cervical cancer histologically proven (squamous cell carcinoma, adenocarcinoma and neuroendocrine cell carcinoma)

• Utero-vaginal brachytherapy indications::

  • Stage 1B1: brachytherapy before surgery
  • Stages IB2 to IIIB: after pelvic radiotherapy (45Gy/25 fractions/5 weeks) with or without concomitant chemotherapy

• Ability to provide an informed written consent form

• Patient must be affiliated to a social security system

Exclusion criteria

• Age < 18 years old
• History of pelvic radiotherapy
• History of pelvic surgery
• Recent joint prothesis (<3 months)
• Pregnant woman or being breastfeeding
• Patients deprived of liberty or under supervision

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

ARM 1

Experimental group

Treatment:

Other: brachytherapy