Comparison Of Vaginal Gauze Packing Technique With or Without Balloon In High Dose Rate Brachytherapy Of Uterine Cervical Cancer- A Crossover Randomized Controlled Trial.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Rectal and bladder radiation doses, expressed as maximum doses received to
Study Overview
Brief Summary
This study compares vaginal gauze packing technique with or without balloon in the treatment of uterine cervical cancer using high dose rate intracavitary brachytherapy. This is a randomized controlled trial with crossover design. 36 patients will be recruited after completion of external beam radiotherapy and are eligible for intracavitary brachytherapy. They will be randomized to receive first session of brachytherapy with either the control (vaginal gauze packing alone) or experimental (combined vaginal balloon and gauze packing) techniques. For the second session of brachytherapy, patients will be crossed over. The last session of brachytherapy will not be considered as a part of the trial. CT based planning will be done and dosimetric data will be collected for the bladder and rectum. A comparison will be made for the bladder and rectal dose between the two techniques. In addition, pre and post-procedural CT scans will be done to evaluate the applicator stability.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Patients with uterine cervical cancer who have completed external beam radiotherapy and are found fit for intracavitary brachytherapy.
Exclusion Criteria
- •Patients with an ECOG Performance status >
- •Patients who had undergone previous pelvic surgery.
- •Patients who had undergone previous radiation therapy.
- •Age less than 18 years.
Outcomes
Primary Outcomes
Rectal and bladder radiation doses, expressed as maximum doses received to
Time Frame: 1st and 2nd fractions of brachytherapy
respective organ volumes of 0.5cc,1cc and 2cc, as calculated in the CT-based
Time Frame: 1st and 2nd fractions of brachytherapy
brachytherapy treatment plan.
Time Frame: 1st and 2nd fractions of brachytherapy
Secondary Outcomes
- Rectal and bladder radiation doses, expressed as maximum doses received to(respective organ volumes of 0.5cc,1cc and 2cc, as calculated in the CT-based)