Cervical Cancer
Conditions
Keywords
Brachytherapy
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.
Interventions
DEVICEBrachyGel VHPS
Packing system for administering brachytherapy in cervical cancer patients
Sponsors
BrachyFoam, LLC
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Biopsy showing cancer of the cervix (squamous cell carcinoma, adenocarcinoma, adenosquamous, neuroendocrine, etc) 2. FIGO IB1 - IVB Staging according to FIGO and TNM guidelines 3. Planning to receive brachytherapy as a part of the definitive treatment for cervical cancer 4. Karnofsky performance status (KPS) ≥ 70 or ECOG status ≤1 5. Stated willingness to comply with all study procedures and availability for the duration of the study 6. Age ≥ 18 years 7. Agreement to adhere to Lifestyle Considerations throughout study duration
Exclusion criteria
1. History of pelvis or abdominal radiation therapy (RT) that is not a part of the definitive treatment plan for the cancer of interest 2. History of total or partial hysterectomy 3. Plan to receive external beam RT (EBRT) alone as the definitive treatment plan for the cancer of interest 4. Known pregnancy or lactation (no pregnancy test required prior to participation) 5. Known contraindications to brachytherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetry Comparison of Packing System in OARs | Fractions 2 and 3 about 1 - 2 weeks after starting brachytherapy | The mean difference in bladder and rectum doses between Gauze and BrachyGel for fractions 2 and 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | From the completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days) | Frequency and intensity (CTCAE v5 grade) of AEs |
| Dosimetry Comparison of Packing System in OARs | Fractions 2 and 5 about 1 - 4 weeks after starting brachytherapy | The mean difference in bladder and rectum doses between Gauze and BrachyGel for fractions 2 through 5. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited based on physician referral at one academic medical center between March 2021 and September 2022. Participants were randomized with equal allocation to each ordering (Arm A or Arm B) using a stratified block randomization scheme with varying block sizes (of 2-4). Randomization occurred prior to the 2nd fraction of brachytherapy.
Pre-assignment details
Fraction 1 for all participants (both Arms) was performed with standard of care packing. One patient of the 21 patients enrolled and randomized did not receive brachytherapy due to disease progression.
Participants by arm
| Arm | Count |
|---|---|
| Arm A: BrachyGel in Fractions 3 and 5 BrachyGel VHPS in fractions 3 and 5 and standard packing in fractions 2 and 4
BrachyGel VHPS: Packing system for administering brachytherapy in cervical cancer patients | 10 |
| Arm B: BrachyGel in Fractions 2 and 4 BrachyGel VHPS in fractions 2 and 4 and standard packing in fractions 3 and 5
BrachyGel VHPS: Packing system for administering brachytherapy in cervical cancer patients | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Disease Progression | 1 | 0 |
Baseline characteristics
| Characteristic | Arm B: BrachyGel in Fractions 2 and 4 | Total | Arm A: BrachyGel in Fractions 3 and 5 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 16 Participants | 8 Participants |
| Age, Continuous | 51 years | 51.95 years | 52.9 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 9 Participants | 17 Participants | 8 Participants |
| Region of Enrollment United States | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 2 / 10 | 2 / 10 | 5 / 10 | 5 / 10 | 3 / 10 | 6 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Dosimetry Comparison of Packing System in OARs
The mean difference in bladder and rectum doses between Gauze and BrachyGel for fractions 2 and 3
Time frame: Fractions 2 and 3 about 1 - 2 weeks after starting brachytherapy
Population: 19 participants were evaluated. A major protocol deviation that occurred for one ARM B subject during fraction (Fx) 2 of brachytherapy (use of an incorrect packing method). This subject is not included in the analysis of this endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D2cc | 3.071 Mean in Dose (Gray) | Standard Deviation 0.386 |
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D1cc | 3.745 Mean in Dose (Gray) | Standard Deviation 0.774 |
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | HR-CTVD90 | 6.518 Mean in Dose (Gray) | Standard Deviation 1.313 |
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D2cc | 3.436 Mean in Dose (Gray) | Standard Deviation 0.684 |
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D0.1cc | 4.117 Mean in Dose (Gray) | Standard Deviation 0.713 |
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D0.1cc | 4.457 Mean in Dose (Gray) | Standard Deviation 1.035 |
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D1cc | 3.417 Mean in Dose (Gray) | Standard Deviation 0.492 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D0.1cc | 4.34 Mean in Dose (Gray) | Standard Deviation 0.681 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D2cc | 3.26 Mean in Dose (Gray) | Standard Deviation 0.357 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | HR-CTVD90 | 6.638 Mean in Dose (Gray) | Standard Deviation 0.901 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D1cc | 3.601 Mean in Dose (Gray) | Standard Deviation 0.586 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D1cc | 3.591 Mean in Dose (Gray) | Standard Deviation 0.405 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D2cc | 3.319 Mean in Dose (Gray) | Standard Deviation 0.586 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D0.1cc | 4.311 Mean in Dose (Gray) | Standard Deviation 0.78 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D1cc | 3.51 Mean in Dose (Gray) | Standard Deviation 0.789 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D2cc | 3.636 Mean in Dose (Gray) | Standard Deviation 0.772 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | HR-CTVD90 | 5.917 Mean in Dose (Gray) | Standard Deviation 0.893 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D0.1cc | 4.381 Mean in Dose (Gray) | Standard Deviation 1.06 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D1cc | 4.026 Mean in Dose (Gray) | Standard Deviation 0.845 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D2cc | 3.211 Mean in Dose (Gray) | Standard Deviation 0.693 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D0.1cc | 4.911 Mean in Dose (Gray) | Standard Deviation 1.018 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | HR-CTVD90 | 6.575 Mean in Dose (Gray) | Standard Deviation 0.869 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D2cc | 3.03 Mean in Dose (Gray) | Standard Deviation 0.722 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D1cc | 3.908 Mean in Dose (Gray) | Standard Deviation 0.828 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D1cc | 3.316 Mean in Dose (Gray) | Standard Deviation 0.812 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D0.1cc | 4.705 Mean in Dose (Gray) | Standard Deviation 0.916 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D0.1cc | 4.028 Mean in Dose (Gray) | Standard Deviation 1.134 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D2cc | 3.573 Mean in Dose (Gray) | Standard Deviation 0.791 |
Comparison: Mean difference between Gauze and Gel ARM A Bladder D2cc95% CI: [-0.27, 0.5]
Comparison: Mean difference between Gauze and Gel ARM B Bladder D2cc95% CI: [-0.94, 0.96]
Comparison: Mean difference between Gauze and Gel ARM A Rectum D2cc95% CI: [-0.54, 0.16]
Comparison: Mean difference between Gauze and Gel ARM B Rectum D2cc95% CI: [-0.67, 0.29]
Secondary
Adverse Events
Frequency and intensity (CTCAE v5 grade) of AEs
Time frame: From the completion of the 2nd brachytherapy treatment to 1 month after the last brachytherapy treatment (up to 70 days)
Population: All participants who received at least Brachytherapy Fraction 2
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ARM A Fraction 2 | Adverse Events | Vaginal pain Grade 2 | 2 Occurences |
| ARM A Fraction 2 | Adverse Events | Vaginal pain Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Infection (Scabies)* Grade 3 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Vaginal hemorrhage (Spotting) Grade 1 | 1 Occurences |
| ARM A Fraction 2 | Adverse Events | Vaginal dryness (itching) Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Vaginal inflammation Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Vaginal inflammation Grade 2 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Dysuria Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Dysuria Grade 2 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Urinary urgency Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Pelvic Pain Grade 3 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Pelvic pain (abdominal cramping) Grade 2 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Pelvic pain (abdominal cramping) Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Fatigue Grade 2 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Fatigue Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Diarrhea Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Constipation Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Dyspareunia Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Dermatitis Radiation Grade 2 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Dizziness Grade 2 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Nausea Grade 2 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Vomiting Grade 2 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Cough Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Bloating Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Bone Pain Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Facial Pain Grade 1 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | UTI Grade 2 | 0 Occurences |
| ARM A Fraction 2 | Adverse Events | Vaginal Infection Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Bloating Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Vaginal pain Grade 2 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Fatigue Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Cough Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Dizziness Grade 2 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Infection (Scabies)* Grade 3 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Vaginal Infection Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Diarrhea Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Pelvic pain (abdominal cramping) Grade 2 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Vaginal pain Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Pelvic pain (abdominal cramping) Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Pelvic Pain Grade 3 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Vaginal hemorrhage (Spotting) Grade 1 | 1 Occurences |
| ARM A Fraction 3 | Adverse Events | Constipation Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Facial Pain Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Vaginal dryness (itching) Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | UTI Grade 2 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Nausea Grade 2 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Vaginal inflammation Grade 1 | 1 Occurences |
| ARM A Fraction 3 | Adverse Events | Bone Pain Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Dyspareunia Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Vaginal inflammation Grade 2 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Fatigue Grade 2 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Urinary urgency Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Dysuria Grade 1 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Dermatitis Radiation Grade 2 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Vomiting Grade 2 | 0 Occurences |
| ARM A Fraction 3 | Adverse Events | Dysuria Grade 2 | 0 Occurences |
| ARM B Fraction 2 | Adverse Events | Nausea Grade 2 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Vomiting Grade 2 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Urinary urgency Grade 1 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Pelvic Pain Grade 3 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Cough Grade 1 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Pelvic pain (abdominal cramping) Grade 1 | 3 Occurences |
| ARM B Fraction 2 | Adverse Events | Fatigue Grade 2 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Fatigue Grade 1 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Bloating Grade 1 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Diarrhea Grade 1 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | UTI Grade 2 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Constipation Grade 1 | 2 Occurences |
| ARM B Fraction 2 | Adverse Events | Dyspareunia Grade 1 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Bone Pain Grade 1 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Dermatitis Radiation Grade 2 | 2 Occurences |
| ARM B Fraction 2 | Adverse Events | Vaginal pain Grade 2 | 2 Occurences |
| ARM B Fraction 2 | Adverse Events | Vaginal Infection Grade 1 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Infection (Scabies)* Grade 3 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Pelvic pain (abdominal cramping) Grade 2 | 2 Occurences |
| ARM B Fraction 2 | Adverse Events | Vaginal pain Grade 1 | 3 Occurences |
| ARM B Fraction 2 | Adverse Events | Dizziness Grade 2 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Vaginal hemorrhage (Spotting) Grade 1 | 2 Occurences |
| ARM B Fraction 2 | Adverse Events | Vaginal dryness (itching) Grade 1 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Vaginal inflammation Grade 1 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Dysuria Grade 2 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Vaginal inflammation Grade 2 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Facial Pain Grade 1 | 1 Occurences |
| ARM B Fraction 2 | Adverse Events | Dysuria Grade 1 | 1 Occurences |
Secondary
Dosimetry Comparison of Packing System in OARs
The mean difference in bladder and rectum doses between Gauze and BrachyGel for fractions 2 through 5.
Time frame: Fractions 2 and 5 about 1 - 4 weeks after starting brachytherapy
Population: A major protocol deviation that occurred for one ARM B subject during fraction (Fx) 2 of brachytherapy (use of an incorrect packing method). Two subjects one from ARM A and one from ARM B only received 4 fractions of treatment. These subjects are not included in the analysis of this endpoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D1cc | 3.417 Mean in dose (Gray) | Standard Deviation 0.492 |
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D1cc | 3.745 Mean in dose (Gray) | Standard Deviation 0.774 |
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | HR-CTVD90 | 6.518 Mean in dose (Gray) | Standard Deviation 1.313 |
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D2cc | 3.436 Mean in dose (Gray) | Standard Deviation 0.684 |
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D0.1cc | 4.117 Mean in dose (Gray) | Standard Deviation 0.713 |
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D0.1cc | 4.457 Mean in dose (Gray) | Standard Deviation 1.035 |
| ARM A Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D2cc | 3.071 Mean in dose (Gray) | Standard Deviation 0.386 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D2cc | 3.26 Mean in dose (Gray) | Standard Deviation 0.357 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D1cc | 3.601 Mean in dose (Gray) | Standard Deviation 0.586 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D0.1cc | 4.34 Mean in dose (Gray) | Standard Deviation 0.681 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | HR-CTVD90 | 6.638 Mean in dose (Gray) | Standard Deviation 0.901 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D1cc | 3.591 Mean in dose (Gray) | Standard Deviation 0.405 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D0.1cc | 4.311 Mean in dose (Gray) | Standard Deviation 0.78 |
| ARM A Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D2cc | 3.319 Mean in dose (Gray) | Standard Deviation 0.586 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D2cc | 3.287 Mean in dose (Gray) | Standard Deviation 1.058 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D2cc | 3.035 Mean in dose (Gray) | Standard Deviation 0.627 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | HR-CTVD90 | 6.749 Mean in dose (Gray) | Standard Deviation 1.501 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D1cc | 3.611 Mean in dose (Gray) | Standard Deviation 1.142 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D1cc | 3.378 Mean in dose (Gray) | Standard Deviation 0.664 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D0.1cc | 4.322 Mean in dose (Gray) | Standard Deviation 1.352 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D0.1cc | 4.2 Mean in dose (Gray) | Standard Deviation 0.795 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | HR-CTVD90 | 6.692 Mean in dose (Gray) | Standard Deviation 0.522 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D1cc | 4.166 Mean in dose (Gray) | Standard Deviation 0.873 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D2cc | 2.936 Mean in dose (Gray) | Standard Deviation 0.847 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D1cc | 3.201 Mean in dose (Gray) | Standard Deviation 0.919 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D0.1cc | 4.974 Mean in dose (Gray) | Standard Deviation 1.144 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D2cc | 3.798 Mean in dose (Gray) | Standard Deviation 0.771 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D0.1cc | 3.846 Mean in dose (Gray) | Standard Deviation 1.054 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D2cc | 3.211 Mean in dose (Gray) | Standard Deviation 0.693 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D0.1cc | 4.381 Mean in dose (Gray) | Standard Deviation 1.06 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D1cc | 4.026 Mean in dose (Gray) | Standard Deviation 0.845 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | HR-CTVD90 | 5.917 Mean in dose (Gray) | Standard Deviation 0.893 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D0.1cc | 4.911 Mean in dose (Gray) | Standard Deviation 1.018 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Bladder D2cc | 3.636 Mean in dose (Gray) | Standard Deviation 0.772 |
| ARM B Fraction 2 | Dosimetry Comparison of Packing System in OARs | Rectum D1cc | 3.51 Mean in dose (Gray) | Standard Deviation 0.789 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | HR-CTVD90 | 6.575 Mean in dose (Gray) | Standard Deviation 0.869 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D2cc | 3.03 Mean in dose (Gray) | Standard Deviation 0.722 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D1cc | 3.316 Mean in dose (Gray) | Standard Deviation 0.812 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Rectum D0.1cc | 4.028 Mean in dose (Gray) | Standard Deviation 1.134 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D1cc | 3.908 Mean in dose (Gray) | Standard Deviation 0.828 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D2cc | 3.573 Mean in dose (Gray) | Standard Deviation 0.791 |
| ARM B Fraction 3 | Dosimetry Comparison of Packing System in OARs | Bladder D0.1cc | 4.705 Mean in dose (Gray) | Standard Deviation 0.916 |
| ARM B Fraction 4 | Dosimetry Comparison of Packing System in OARs | Rectum D2cc | 2.761 Mean in dose (Gray) | Standard Deviation 0.664 |
| ARM B Fraction 4 | Dosimetry Comparison of Packing System in OARs | Rectum D1cc | 3.015 Mean in dose (Gray) | Standard Deviation 0.725 |
| ARM B Fraction 4 | Dosimetry Comparison of Packing System in OARs | Bladder D1cc | 3.453 Mean in dose (Gray) | Standard Deviation 1.234 |
| ARM B Fraction 4 | Dosimetry Comparison of Packing System in OARs | Bladder D2cc | 3.157 Mean in dose (Gray) | Standard Deviation 1.174 |
| ARM B Fraction 4 | Dosimetry Comparison of Packing System in OARs | HR-CTVD90 | 6.807 Mean in dose (Gray) | Standard Deviation 1.262 |
| ARM B Fraction 4 | Dosimetry Comparison of Packing System in OARs | Rectum D0.1cc | 3.817 Mean in dose (Gray) | Standard Deviation 1.068 |
| ARM B Fraction 4 | Dosimetry Comparison of Packing System in OARs | Bladder D0.1cc | 4.287 Mean in dose (Gray) | Standard Deviation 1.518 |
| ARM B Fraction 5 | Dosimetry Comparison of Packing System in OARs | Bladder D0.1cc | 5.031 Mean in dose (Gray) | Standard Deviation 1.186 |
| ARM B Fraction 5 | Dosimetry Comparison of Packing System in OARs | Rectum D1cc | 3.236 Mean in dose (Gray) | Standard Deviation 0.73 |
| ARM B Fraction 5 | Dosimetry Comparison of Packing System in OARs | Rectum D2cc | 2.993 Mean in dose (Gray) | Standard Deviation 0.67 |
| ARM B Fraction 5 | Dosimetry Comparison of Packing System in OARs | Bladder D2cc | 3.649 Mean in dose (Gray) | Standard Deviation 0.916 |
| ARM B Fraction 5 | Dosimetry Comparison of Packing System in OARs | HR-CTVD90 | 6.284 Mean in dose (Gray) | Standard Deviation 0.543 |
| ARM B Fraction 5 | Dosimetry Comparison of Packing System in OARs | Rectum D0.1cc | 3.823 Mean in dose (Gray) | Standard Deviation 0.835 |
| ARM B Fraction 5 | Dosimetry Comparison of Packing System in OARs | Bladder D1cc | 4.072 Mean in dose (Gray) | Standard Deviation 0.977 |