Back to results

A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer

Primary Purpose

Cervical Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BrachyGel VHPS

About this trial

This is an interventional supportive care trial for Cervical Cancer focused on measuring Brachytherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Biopsy showing cancer of the cervix (squamous cell carcinoma, adenocarcinoma, adenosquamous, neuroendocrine, etc)
FIGO IB1 - IVB Staging according to FIGO and TNM guidelines
Planning to receive brachytherapy as a part of the definitive treatment for cervical cancer
Karnofsky performance status (KPS) ≥ 70 or ECOG status ≤1
Stated willingness to comply with all study procedures and availability for the duration of the study
Age ≥ 18 years
Agreement to adhere to Lifestyle Considerations throughout study duration

Exclusion Criteria:

History of pelvis or abdominal radiation therapy (RT) that is not a part of the definitive treatment plan for the cancer of interest"
History of total or partial hysterectomy
Plan to receive external beam RT (EBRT) alone as the definitive treatment plan for the cancer of interest
Known pregnancy or lactation (no pregnancy test required prior to participation)
Known contraindications to brachytherapy

Sites / Locations

University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A: BrachyGel in fractions 3 and 5

Arm B: BrachyGel in fractions 2 and 4

Arm Description

BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4

BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5

Outcomes

Primary Outcome Measures

Highest dose of radiation (in Gy) to the rectum and bladder for each patient

This number (dose) is based on the radiation treatment plan

Secondary Outcome Measures

Adverse Events

Frequency, intensity, and duration of adverse events

Highest dose of radiation (in Gy) to the rectum and bladder for each patient at each treatment

This number (dose) is based on the radiation treatment plan

Full Information

NCT ID

NCT04499521

First Posted

July 22, 2020

Last Updated

September 7, 2023

Sponsor

University of Virginia

Collaborators

BrachyFoam, LLC

1. Study Identification

Unique Protocol Identification Number

NCT04499521

Brief Title

A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer

Official Title

A Randomized, Non-Inferiority Study of a Hydrogel Packing System Compared to Standard of Care Packing During Image-Guided High-Dose Rate Brachytherapy Boost for Cervical Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 17, 2021 (Actual)

Primary Completion Date

September 30, 2022 (Actual)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

Collaborators

BrachyFoam, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In this study, a new, low cost packing system ("BrachyGel VHPS") is being tested as a packing option during brachytherapy along with standard options to make sure that it keeps the unrelated organs away from radiation at least as well as the standard options, and to better understand the safety and patient discomfort associated with BrachyGel VHPS and the standard packing options.

Detailed Description

As part of vaginal brachytherapy, the organs that do not need to receive radiation (unrelated organs) are moved out of the way of the radiation with a "packing system". The usual low cost and available standard of care packing systems to move these unrelated organs out of the way can sometimes be uncomfortable for the patient, may not move all of the unrelated organs all the way out of the radiation's path, and rely on the doctor to place them correctly. If you participate, you will receive 5 fractions of brachytherapy according to standard clinical care. For three of the fractions, a standard packing option will be used and for two of them BrachyGel VHPS will be used. For the first fraction both groups will have the same packing option but participants will be randomized to either have BrachyGel during fractions 2 and 4 or during fractions 3 and 5. You'll be asked to complete a questionnaire after fractions 2-5 to get your feedback on any discomfort you have during or after brachytherapy from the packing system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

Keywords

Brachytherapy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Both groups will have two fractions of brachytherapy with a standard packing system and two fractions of brachytherapy with BrachyGel VHPS - only the timing will be different between the two groups.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: BrachyGel in fractions 3 and 5

Arm Type

Experimental

Arm Description

BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4

Arm Title

Arm B: BrachyGel in fractions 2 and 4

Arm Type

Experimental

Arm Description

BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5

Intervention Type

Device

Intervention Name(s)

BrachyGel VHPS

Intervention Description

Packing system for administering brachytherapy in cervical cancer patients

Primary Outcome Measure Information:

Title

Highest dose of radiation (in Gy) to the rectum and bladder for each patient

Description

This number (dose) is based on the radiation treatment plan

Time Frame

Fractions 2 and 3: About 1-2 weeks after starting brachytherapy

Secondary Outcome Measure Information:

Title

Adverse Events

Description

Frequency, intensity, and duration of adverse events

Time Frame

Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy

Title

Highest dose of radiation (in Gy) to the rectum and bladder for each patient at each treatment

Description

This number (dose) is based on the radiation treatment plan

Time Frame

Fractions/Radiation treatments 2 - 5: About 1-4 weeks after starting brachytherapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Biopsy showing cancer of the cervix (squamous cell carcinoma, adenocarcinoma, adenosquamous, neuroendocrine, etc) FIGO IB1 - IVB Staging according to FIGO and TNM guidelines Planning to receive brachytherapy as a part of the definitive treatment for cervical cancer Karnofsky performance status (KPS) ≥ 70 or ECOG status ≤1 Stated willingness to comply with all study procedures and availability for the duration of the study Age ≥ 18 years Agreement to adhere to Lifestyle Considerations throughout study duration Exclusion Criteria: History of pelvis or abdominal radiation therapy (RT) that is not a part of the definitive treatment plan for the cancer of interest" History of total or partial hysterectomy Plan to receive external beam RT (EBRT) alone as the definitive treatment plan for the cancer of interest Known pregnancy or lactation (no pregnancy test required prior to participation) Known contraindications to brachytherapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kara Romano

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Randomized Study to Compare a Hydrogel Packing System to Standard Packing During HDR Brachytherapy for Cervical Cancer

We'll reach out to this number within 24 hrs