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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00029263 | Other Identifier | JHMIRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDRBT (High Dose Rectal Brachytherapy) | Experimental | 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. A daily dose of 6.5 Gy over four consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-dose endorectal brachytherapy (HDRBT) | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amol K Narang, M.D. | Johns Hopkins Department of Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medical Institutions | Baltimore | Maryland | 21231 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-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. Daily dose of 6.5 Gy over four consecutive days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 8 weeks |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-Dose-Rate 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. Daily dose of 6.5 Gy over four consecutive days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amol Narang, MD | SKCCC at Johns Hopkinis | (410) 955-7390 | anarang2@jhmi.edu |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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High-Dose-Rate Endorectal Brachytherapy (HDRBT)
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|
| 3 to 6 weeks post-treatment |
| 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. | 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 |
| 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. | 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 |
| 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. | 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 |
| 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. | 3-6 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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. | One patient had to go into surgery and it was not possible to do the imaging necessary for this assessment. | Posted | Count of Participants | Participants | 3 to 6 weeks post-treatment |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
| 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. | Posted | Count of Participants | Participants | 3-6 weeks |
|
|
|
| 0 |
| 16 |
| 3 |
| 16 |
| 16 |
| 16 |
| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Proctitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Fecal Incontinence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| GI - hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| WBC count decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Lymphocyte count decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| ALT increase | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Urinary Frequency/urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Erectile dysfunction | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Neutrophil count decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Platelet count deceased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Alkaline phosphatase increased | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Aspartate Amino Transferase increased | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| AST increased | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyponatremia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Alanine Amino Transferase Increased | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Blood bilirubin increased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Rectal Obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Rectal stenosis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Vaginal dryness | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting | General disorders | CTCAE (4.0) | Systematic Assessment |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| Title | Measurements |
|---|---|
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| Stable disease |
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| 1 week Post-HDRBT Treatment |
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| 2 Weeks Post-HDRBT Treatment |
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| 3-6 weeks Post-HDRBT Treatment |
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| 3-6 weeks post-op |
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| 4 Months post-op |
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| 8 Months post-op |
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| 12 Months post-op |
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| 16 Months post-op |
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| 20 Months post-op |
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| 24 Months post-op |
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| 30 Months post-op |
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| 36 Months post-op |
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| 42 Months post-op |
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| 48 Months post-op |
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| 1 week Post-HDRBT Treatment |
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| 2 Weeks Post-HDRBT Treatment |
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| weeks 3-6 Post-HDRBT Treatment |
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| 3-6 weeks post-op |
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| 4 Months post-op |
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| 8 Months post-op |
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| 12 Months post-op |
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| 16 Months post-op |
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| 20 Months post-op |
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| 24 Months post-op |
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| 30 Months post-op |
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| 36 Months post-op |
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| 42 Months post-op |
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| 48 Months post-op |
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| 1 week Post-HDRBT Treatment |
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| 2 Weeks Post-HDRBT Treatment |
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| 3-6 weeks Post-HDRBT Treatment |
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| 3-6 weeks post-op |
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| 4 Months post-op |
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| 8 Months post-op |
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| 12 Months post-op |
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| 16 Months post-op |
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| 20 Months post-op |
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| 24 Months post-op |
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| 30 Months post-op |
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| 36 Months post-op |
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| 42 Months post-op |
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| 48 Months post-op |
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