Rectal Cancer
Conditions
Keywords
rectal cancer, high dose endorectal brachytherapy
Brief summary
This research is being done to see how effective high-dose rate endorectal brachytherapy (HDRBT) is in treating cancer of the lowest part of the bowel (rectum). In this study we want to try to decrease side effects and shorten the course of radiation treatment for patients with cancer of their rectum by using a high-dose rate endorectal brachytherapy (HDRBT). This is a different form of radiation than what is normally given (CRT). With HDRBT, the radiation is given through an applicator placed into the bowel next to the tumor. The radiation is directed at the tumor and a small area around it.
Detailed description
This study is a pilot study open to patients with clinical stage T2N1 or T3N0-1 resectable rectal cancer. The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer. This study assumes that the rate of pathological response to HDRBT will be similar to historical controls (conventional neoadjuvant chemoradiation). All patients will receive postoperative standard 5-fluorouracil (FU) based chemotherapy (at the discretion of the medical oncologist). The clinical response will be assessed with endoscopic/ultrasound, pelvic MRI and fluorodeoxyglucose (FDG)-positron emission tomography (PET)/CT. In addition, tissue and serum will be collected to evaluate for biological predictors of response to therapy. The endpoints of this study include adverse events (gastrointestinal toxicity), quality of life as measured by the quality of life questionnaire (QLQ)-C30, and tumor regression/response.
Interventions
RADIATIONHigh-dose endorectal brachytherapy (HDRBT)
The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
High-Dose-Rate Endorectal Brachytherapy (HDRBT)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patients with histologically confirmed adenocarcinoma of the rectum * Able to undergo local staging of the rectal tumor performed by MRI and/or endoscopic ultrasonography (EUS) demonstrating a T2N1 or T3N0-1 tumor * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participants are willing to undergo initial therapy and if needed subsequent therapy prior to resection at Johns Hopkins Medical Institutions * English as a primary language in order to complete the quality of life questionnaires
Exclusion criteria
* Patients with tumors \>12 cm from the anal verge. * Near obstructing or bulky tumors which will not allow application of the endorectal probe * Patients with distant metastatic disease * Any pelvic lymph nodes outside of the mesorectum (iliac or inguinal) * Prior history of radiation therapy to the pelvis * Prior history of chemotherapy for rectal cancer * Active connective tissue disease such as scleroderma or Crohn's disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pathologic Complete Response | 8 weeks | Those participants whose surgical pathology indicated that they had a complete response measured by RECIST. Per Response Evaluation Criteria In Solid Tumors (RECISTv1.0). Complete response (CR) indicating no tumors, a partial (PR) response indicating at least a 30% decrease in tumor diameter (PR), progressive disease (PD) indicating 20% or greater increase in tumor diameter, and stable disease (SD) indicating that the tumor did not shrink significantly to be considered a partial response and did not grow significantly enough to be considered progressive disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT) Brachytherapy | 3 to 6 weeks post-treatment | Radiographic measurements of pelvic MRI and fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT imaging will be used to classify patients as responders or non-responders to HDRBT using standard RECIST criteria. Response Evaluation Criteria In Solid Tumors (RECISTv1.0) is defined as follows: Complete response (CR) indicating no tumors, a partial (PR) response indicating at least a 30% decrease in tumor diameter (PR), progressive disease (PD) indicating 20% or greater increase in tumor diameter, and stable disease (SD) indicating that the tumor did not shrink significantly to be considered a partial response and did not grow significantly enough to be considered progressive disease. |
| Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 weeks post-op, every 4 months for 2 years and every 6 months for years 3 and 4 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 form is a self-assessment completed by patients which examines current symptoms and functionality. Total score ranges from 0 to 100, a higher score represents a higher (better) quality of life. |
| Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 week post-op, every 4 months for 2 years and every 6 months for years 3 and 4 | The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-CR38 form is a self-assessment completed by patients and examine current symptoms and functionality. Each item is scored from 1 to 4. Total score range is from 38-152. A higher score represents better quality of life. |
| Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 week post-op, every 4 months for 2 years and every 6 months for years 3 and 4 | The European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) form is a self-assessment completed by patients and examine current symptoms and functionality. Each item is scored from 1 to 4. Total score ranges from 29 - 116. A higher score represents better quality of life. |
| Number of Participants With Acute Gastrointestinal Toxicity Associated With High-Dose-Rate Endorectal Brachytherapy (HDRBT) as Assessed by CTCAE v4.0 | 3-6 weeks | Acute gastrointestinal toxicity will be assessed using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0). CTCAE v4.0 ratings of 3 or 4 (seriousness of 17%) adverse events will be assessed and reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HDRBT Radiation: High-dose endorectal brachytherapy The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
High-dose endorectal brachytherapy: The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | HDRBT |
|---|---|
| Age, Continuous | 53.2 years STANDARD_DEVIATION 14.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 16 / 16 |
| serious Total, serious adverse events | 3 / 16 |
Outcome results
Primary
Number of Participants With Pathologic Complete Response
Those participants whose surgical pathology indicated that they had a complete response measured by RECIST. Per Response Evaluation Criteria In Solid Tumors (RECISTv1.0). Complete response (CR) indicating no tumors, a partial (PR) response indicating at least a 30% decrease in tumor diameter (PR), progressive disease (PD) indicating 20% or greater increase in tumor diameter, and stable disease (SD) indicating that the tumor did not shrink significantly to be considered a partial response and did not grow significantly enough to be considered progressive disease.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HDRBT (High Dose Rectal Brachytherapy) | Number of Participants With Pathologic Complete Response | 5 Participants |
Secondary
Number of Participants With Acute Gastrointestinal Toxicity Associated With High-Dose-Rate Endorectal Brachytherapy (HDRBT) as Assessed by CTCAE v4.0
Acute gastrointestinal toxicity will be assessed using the Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0). CTCAE v4.0 ratings of 3 or 4 (seriousness of 17%) adverse events will be assessed and reported.
Time frame: 3-6 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HDRBT (High Dose Rectal Brachytherapy) | Number of Participants With Acute Gastrointestinal Toxicity Associated With High-Dose-Rate Endorectal Brachytherapy (HDRBT) as Assessed by CTCAE v4.0 | Grade 3 pain | 2 Participants |
| HDRBT (High Dose Rectal Brachytherapy) | Number of Participants With Acute Gastrointestinal Toxicity Associated With High-Dose-Rate Endorectal Brachytherapy (HDRBT) as Assessed by CTCAE v4.0 | Grade 3 Proctitis | 1 Participants |
Secondary
Number of Participants With Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT) Brachytherapy
Radiographic measurements of pelvic MRI and fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT imaging will be used to classify patients as responders or non-responders to HDRBT using standard RECIST criteria. Response Evaluation Criteria In Solid Tumors (RECISTv1.0) is defined as follows: Complete response (CR) indicating no tumors, a partial (PR) response indicating at least a 30% decrease in tumor diameter (PR), progressive disease (PD) indicating 20% or greater increase in tumor diameter, and stable disease (SD) indicating that the tumor did not shrink significantly to be considered a partial response and did not grow significantly enough to be considered progressive disease.
Time frame: 3 to 6 weeks post-treatment
Population: One patient had to go into surgery and it was not possible to do the imaging necessary for this assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HDRBT (High Dose Rectal Brachytherapy) | Number of Participants With Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT) Brachytherapy | Complete Response | 1 Participants |
| HDRBT (High Dose Rectal Brachytherapy) | Number of Participants With Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT) Brachytherapy | Partial response | 13 Participants |
| HDRBT (High Dose Rectal Brachytherapy) | Number of Participants With Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT) Brachytherapy | Progressive disease | 0 Participants |
| HDRBT (High Dose Rectal Brachytherapy) | Number of Participants With Clinical Response of High-Dose-Rate Endorectal Brachytherapy (HDRBT) Brachytherapy | Stable disease | 1 Participants |
Secondary
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores
The European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) form is a self-assessment completed by patients and examine current symptoms and functionality. Each item is scored from 1 to 4. Total score ranges from 29 - 116. A higher score represents better quality of life.
Time frame: Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 week post-op, every 4 months for 2 years and every 6 months for years 3 and 4
Population: Not all participants could be assessed at all the time points therefore data was not collected for some participants at some points as shown by participants for those time points being less than 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | Pre-HDRBT | 34.56 score on a scale | Standard Deviation 6.03 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | During HDRBT | 32.3 score on a scale | Standard Deviation 5.27 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 1 week Post-HDRBT Treatment | 37.46 score on a scale | Standard Deviation 9.91 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 2 Weeks Post-HDRBT Treatment | 34 score on a scale | Standard Deviation 11.53 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 3-6 weeks Post-HDRBT Treatment | 41.78 score on a scale | Standard Deviation 14.62 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 3-6 weeks post-op | 42.6 score on a scale | Standard Deviation 10.47 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 4 Months post-op | 42.2 score on a scale | Standard Deviation 3.96 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 8 Months post-op | 43 score on a scale | Standard Deviation 6.82 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 12 Months post-op | 42 score on a scale | Standard Deviation 6.78 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 16 Months post-op | 41.22 score on a scale | Standard Deviation 5.36 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 20 Months post-op | 35.56 score on a scale | Standard Deviation 6.78 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 24 Months post-op | 40.2 score on a scale | Standard Deviation 11.56 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 30 Months post-op | 39.71 score on a scale | Standard Deviation 12.72 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 36 Months post-op | 43.5 score on a scale | Standard Deviation 6.95 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 42 Months post-op | 38.5 score on a scale | Standard Deviation 6.56 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire (EORTC QLQ-CR29) Scores | 48 Months post-op | 30.75 score on a scale | Standard Deviation 8.18 |
Secondary
Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-CR38 form is a self-assessment completed by patients and examine current symptoms and functionality. Each item is scored from 1 to 4. Total score range is from 38-152. A higher score represents better quality of life.
Time frame: Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 week post-op, every 4 months for 2 years and every 6 months for years 3 and 4
Population: Not all participants could be assessed at all the time points therefore data was not collected for some participants at some points as shown by participants for those time points being less than 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | Pre-HDRBT | 40.63 score on a scale | Standard Deviation 7.37 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | During HDRBT | 36.8 score on a scale | Standard Deviation 8.77 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | 1 week Post-HDRBT Treatment | 42.08 score on a scale | Standard Deviation 11.24 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | 2 Weeks Post-HDRBT Treatment | 42 score on a scale | Standard Deviation 8.19 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | weeks 3-6 Post-HDRBT Treatment | 48.72 score on a scale | Standard Deviation 17.62 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | 3-6 weeks post-op | 47.8 score on a scale | Standard Deviation 12.14 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | 4 Months post-op | 45.6 score on a scale | Standard Deviation 4.34 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | 8 Months post-op | 50 score on a scale | Standard Deviation 7.78 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | 12 Months post-op | 43.6 score on a scale | Standard Deviation 11.53 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | 16 Months post-op | 47.67 score on a scale | Standard Deviation 5.12 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | 20 Months post-op | 45 score on a scale | Standard Deviation 6.54 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | 24 Months post-op | 47.3 score on a scale | Standard Deviation 9.74 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | 30 Months post-op | 38.86 score on a scale | Standard Deviation 20.76 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | 36 Months post-op | 49.75 score on a scale | Standard Deviation 10.47 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | 42 Months post-op | 46 score on a scale | Standard Deviation 2.16 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CR38) Scores | 48 Months post-op | 38.75 score on a scale | Standard Deviation 3.4 |
Secondary
Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores
The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 form is a self-assessment completed by patients which examines current symptoms and functionality. Total score ranges from 0 to 100, a higher score represents a higher (better) quality of life.
Time frame: Pre-HDRBT, during HDRBT, post HDRBT week 1, week 2, weeks 3-6, 3-6 weeks post-op, every 4 months for 2 years and every 6 months for years 3 and 4
Population: Not all participants could be assessed at all the time points therefore data was not collected for some participants at some points as shown by participants for those time points being less than 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | Pre-HDRBT | 47.5 score on a scale | Standard Deviation 8.53 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | During HDRBT | 50 score on a scale | Standard Deviation 12.45 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 1 week Post-HDRBT Treatment | 52.23 score on a scale | Standard Deviation 7.2 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 2 Weeks Post-HDRBT Treatment | 64.33 score on a scale | Standard Deviation 10.69 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 3-6 weeks Post-HDRBT Treatment | 62.03 score on a scale | Standard Deviation 13.09 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 3-6 weeks post-op | 59.27 score on a scale | Standard Deviation 8.9 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 4 Months post-op | 60.4 score on a scale | Standard Deviation 13.11 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 8 Months post-op | 53 score on a scale | Standard Deviation 8.28 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 12 Months post-op | 54 score on a scale | Standard Deviation 9.48 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 16 Months post-op | 49.89 score on a scale | Standard Deviation 12.54 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 20 Months post-op | 52.11 score on a scale | Standard Deviation 6.27 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 24 Months post-op | 56.5 score on a scale | Standard Deviation 15.96 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 30 Months post-op | 54.29 score on a scale | Standard Deviation 13 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 36 Months post-op | 56.5 score on a scale | Standard Deviation 10.3 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 42 Months post-op | 59.5 score on a scale | Standard Deviation 7.23 |
| HDRBT (High Dose Rectal Brachytherapy) | Patient-reported Quality of Life (QOL) as Assessed by the EORTC QLQ-C30 Scores | 48 Months post-op | 53.75 score on a scale | Standard Deviation 13.45 |