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Slow enrollment
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The purpose of this trial is to determine the maximum tolerated dose (MTD) of hypofractionated IMPT for the reirradiation of locoregionally recurrent rectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) | Experimental |
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| Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) | Experimental |
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| Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy | Radiation | When feasible it is strongly recommended that radiotherapy begin on a Monday |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Reirradiation Using Hypofractionated IMPT |
| From start of treatment through 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Complete Response Rate | -DRE, endoscopy, and cross-sectional imaging will be used to measure clinical complete response rate | Within 6 weeks to 3 months post-completion of radiation therapy (range 7-14 weeks) |
| Median Freedom From Locoregional Progression (FFLP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Waters, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2025 |
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| Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) | Experimental |
|
|
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| MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine | Device | -The device that will administer the IMPT |
|
-Defined as time from end of radiation therapy to date of first instance of local or regional tumor progression |
| Through completion of follow-up (full range 1.81 months-13.87 months) |
| Median Overall Survival (OS) | Defined as time from end of radiation therapy to date that at least 50% of patients died | Through completion of follow-up (full range 4.4 months to 13.87 months) |
| Median Progression-free Survival (PFS) | -Defined as time from end of radiation therapy to the earliest date of locoregional progression, distant progression, or death from any cause | Through completion of follow-up (full range 1.81 months-13.87 months) |
| Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | 30 question survey which assesses patient well-being with 5 functional scales, 9 symptom scales, & global health scale. Scores for each scale range from 0-100. Higher score for the functional scale & global health represent high functioning, while high score for symptom scale represents high symptomatology. Median scores were taken for each scale for each dose level and the different between pre-treatment and post-treatment scores were calculated to determine change in score over time. For functional scales and global health status, negative values represent improved functionality/quality of life, while positive values represent diminished functionality. For symptom scales, the opposite is true. If patients did not complete the the survey at each time point, their data was censored. Data values were averaged prior to 3 months. Differences were taken between baseline values and the average value calculated of post-RT up to 3 months. | Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment |
| Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | 30 question survey which assesses patient well-being with 5 functional scales, 9 symptom scales, & global health scale. Scores for each scale range from 0-100. Higher score for the functional scale & global health represent high functioning, while high score for symptom scale represents high symptomatology. Median scores were taken for each scale for each dose level and the different between pre-treatment and post-treatment scores were calculated to determine change in score over time. For functional scales and global health status, negative values represent improved functionality/quality of life, while positive values represent diminished functionality. For symptom scales, the opposite is true. If patients did not complete the survey at each time point, their data was censored. Data values were averaged from 3-12 months. Differences were taken between baseline values and the average value calculated of post-RT from 3-12 months. | Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment |
| Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29) | 29 question survey which assesses quality of life for patients with colorectal cancer including functional & symptom status. The survey includes 4 multi-item scales & 19 single-item scales. Scores are linearly transformed to provide a score from 0-100. A high score for functional scales represents high level of functioning, while a high score for symptom scale represents high level of symptoms. Median scores were taken for each scale & the difference between baseline & varying time points was reported. Negative value represents improved function for a functional scale item, & worsening symptoms for symptom scale items. Positive values represent the converse. If patients did not complete the survey at each time point, their data was censored. Data values were averaged prior to 3 months. Differences were taken between pre-treatment (baseline) values and the average value calculated of post-RT up to 3 months. | Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment |
| Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29) | 29 question survey which assesses quality of life for patients with colorectal cancer including functional & symptom status. The survey includes 4 multi-item scales & 19 single-item scales. Scores are linearly transformed to provide a score from 0-100. A high score for functional scales represents high level of functioning, while a high score for symptom scale represents high level of symptoms. Median scores were taken for each scale & the difference between baseline & varying time points was reported. Negative value represents improved function for a functional scale item, & worsening symptoms for symptom scale items. Positive values represent the converse. If patients did not complete the survey at each time point, their data was censored. Data values were averaged from 3-12 months. Differences were taken between baseline values and the average value calculated of post-RT from 3-12 months | Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment |
| Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0 | From start of treatment through 3 months after completion of radiation therapy (estimated to be 3 months and 1 week) |
| Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0 | From 3 month post-completion of radiation therapy to 12 months post-completion of radiation therapy |
| FG001 | Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| FG002 | Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
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| FG003 | Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
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| BG001 | Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
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| BG002 | Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
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| BG003 | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
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| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | Maximum Tolerated Dose (MTD) of Reirradiation Using Hypofractionated IMPT |
| 3 participants are not evaluable for this outcome measure. 2 participants did not start treatment. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol. | Posted | Number | GY in 5 fractions | From start of treatment through 6 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Clinical Complete Response Rate | -DRE, endoscopy, and cross-sectional imaging will be used to measure clinical complete response rate | 1 participant is not evaluable in Dose Level 1 because they did not start treatment. 1 participant is not evaluable in Dose Level 3 because they did not start treatment. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the patient. | Posted | Count of Participants | Participants | Within 6 weeks to 3 months post-completion of radiation therapy (range 7-14 weeks) |
| ||||||||||||||||||||||||||||
| Secondary | Median Freedom From Locoregional Progression (FFLP) | -Defined as time from end of radiation therapy to date of first instance of local or regional tumor progression | 1 participant is not evaluable in Dose Level 1 because they did not start treatment. 1 participant is not evaluable in Dose Level 3 because they did not start treatment. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the patient. | Posted | Median | Full Range | months | Through completion of follow-up (full range 1.81 months-13.87 months) |
| |||||||||||||||||||||||||||
| Secondary | Median Overall Survival (OS) | Defined as time from end of radiation therapy to date that at least 50% of patients died | 1 participant is not evaluable in Dose Level 1 because they did not start treatment. 1 participant is not evaluable in Dose Level 3 because they did not start treatment. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the patient. | Posted | Median | Full Range | months | Through completion of follow-up (full range 4.4 months to 13.87 months) |
| |||||||||||||||||||||||||||
| Secondary | Median Progression-free Survival (PFS) | -Defined as time from end of radiation therapy to the earliest date of locoregional progression, distant progression, or death from any cause | 1 participant is not evaluable in Dose Level 1 because they did not start treatment. 1 participant is not evaluable in Dose Level 3 because they did not start treatment. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the patient. | Posted | Median | Full Range | months | Through completion of follow-up (full range 1.81 months-13.87 months) |
| |||||||||||||||||||||||||||
| Secondary | Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | 30 question survey which assesses patient well-being with 5 functional scales, 9 symptom scales, & global health scale. Scores for each scale range from 0-100. Higher score for the functional scale & global health represent high functioning, while high score for symptom scale represents high symptomatology. Median scores were taken for each scale for each dose level and the different between pre-treatment and post-treatment scores were calculated to determine change in score over time. For functional scales and global health status, negative values represent improved functionality/quality of life, while positive values represent diminished functionality. For symptom scales, the opposite is true. If patients did not complete the the survey at each time point, their data was censored. Data values were averaged prior to 3 months. Differences were taken between baseline values and the average value calculated of post-RT up to 3 months. | This outcome measure includes data for participants who completed the questionnaire. If a participant did not complete the questionnaire at a specific time point, then the participant is not included in the number analyzed at that time point. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the participant. | Posted | Median | Full Range | score on a scale | Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment |
| |||||||||||||||||||||||||||
| Secondary | Median Change in Quality of Life (QoL) Score as Measured by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) | 30 question survey which assesses patient well-being with 5 functional scales, 9 symptom scales, & global health scale. Scores for each scale range from 0-100. Higher score for the functional scale & global health represent high functioning, while high score for symptom scale represents high symptomatology. Median scores were taken for each scale for each dose level and the different between pre-treatment and post-treatment scores were calculated to determine change in score over time. For functional scales and global health status, negative values represent improved functionality/quality of life, while positive values represent diminished functionality. For symptom scales, the opposite is true. If patients did not complete the survey at each time point, their data was censored. Data values were averaged from 3-12 months. Differences were taken between baseline values and the average value calculated of post-RT from 3-12 months. | This outcome measure includes data for participants who completed the questionnaire. If a participant did not complete the questionnaire at a specific time point, then the participant is not included in the number analyzed at that time point. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the participant. | Posted | Median | Full Range | score on a scale | Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment |
| |||||||||||||||||||||||||||
| Secondary | Median Change in Quality of Life (QoL) Score as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29) | 29 question survey which assesses quality of life for patients with colorectal cancer including functional & symptom status. The survey includes 4 multi-item scales & 19 single-item scales. Scores are linearly transformed to provide a score from 0-100. A high score for functional scales represents high level of functioning, while a high score for symptom scale represents high level of symptoms. Median scores were taken for each scale & the difference between baseline & varying time points was reported. Negative value represents improved function for a functional scale item, & worsening symptoms for symptom scale items. Positive values represent the converse. If patients did not complete the survey at each time point, their data was censored. Data values were averaged prior to 3 months. Differences were taken between pre-treatment (baseline) values and the average value calculated of post-RT up to 3 months. | This outcome measure includes data for participants who completed the questionnaire. If a participant did not complete the questionnaire at a specific time point, then the participant is not included in the number analyzed at that time point. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the participant. | Posted | Median | Full Range | score on a scale | Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment |
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| Secondary | Median Change in Quality of Life (QoL) Score as Measured by the by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer Module 29 (EORTC QLQ-CR29) | 29 question survey which assesses quality of life for patients with colorectal cancer including functional & symptom status. The survey includes 4 multi-item scales & 19 single-item scales. Scores are linearly transformed to provide a score from 0-100. A high score for functional scales represents high level of functioning, while a high score for symptom scale represents high level of symptoms. Median scores were taken for each scale & the difference between baseline & varying time points was reported. Negative value represents improved function for a functional scale item, & worsening symptoms for symptom scale items. Positive values represent the converse. If patients did not complete the survey at each time point, their data was censored. Data values were averaged from 3-12 months. Differences were taken between baseline values and the average value calculated of post-RT from 3-12 months | This outcome measure includes data for participants who completed the questionnaire. If a participant did not complete the questionnaire at a specific time point, then the participant is not included in the number analyzed at that time point. 1 participant was erroneously treated with dose level -1 (25 Gy) which is not part of the dose levels defined in the protocol and was excluded from this outcome measure as data was not collected on the participant. | Posted | Median | Full Range | score on a scale | Assessed at pre-treatment (baseline), 1-2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment |
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| Secondary | Frequency of Treatment-related Acute Adverse Events as Measured by CTCAE v 5.0 | 1 participant is not evaluable in Dose Level 1 because they did not start treatment. 1 participant is not evaluable in Dose Level 3 because they did not start treatment. | Posted | Count of Participants | Participants | From start of treatment through 3 months after completion of radiation therapy (estimated to be 3 months and 1 week) |
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| Secondary | Frequency of Treatment-related Late Adverse Events as Measured by CTCAE v 5.0 | 1 participant is not evaluable in Dose Level 1 because they did not start treatment. 1 participant is not evaluable in Dose Level 3 because they did not start treatment. 1 participants in Dose Level -1 is not evaluable as patient did not have follow-up to evaluate for late adverse effects. | Posted | Count of Participants | Participants | From 3 month post-completion of radiation therapy to 12 months post-completion of radiation therapy |
|
All-cause mortality was collected through completion of follow-up (full range 4.4 months through 13.87 months). Adverse events were collected from start of treatment through 12 months after completion of radiation therapy.
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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 | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
| 0 | 1 | 1 | 1 | 1 | 1 |
| EG001 | Dose Level 1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
| 2 | 6 | 4 | 6 | 6 | 6 |
| EG002 | Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
| 2 | 3 | 2 | 3 | 3 | 3 |
| EG003 | Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
| 1 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Ischemic bowel | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Rectal perforation | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Redness and drainage around buttocks wound | General disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Chronic abscess | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pelvic infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pelvic abscess (complication from surgery) | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
| |
| Death due to disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Scleral disorder | Eye disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Anal fissure | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Full feeling | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Gastric hemorrhage | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Mouth sore | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Rectal bleeding | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Rectal fistula | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Rectal frequency and urgency | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Rectal pain | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Stool leakage | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Chills | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Cold sensitivity | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Fever | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Pain | General disorders | CTCAE (Unspecified) | Systematic Assessment |
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| COVID-19 infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| Mass or abscess with leaking | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (Unspecified) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE (Unspecified) | Systematic Assessment |
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| Blood lactacte dehydrogenase increased | Investigations | CTCAE (Unspecified) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (Unspecified) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Hypermagnesemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Hypokalemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Buttock pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Muscle ache/tightness | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Muscle cramp | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Sciatic pain | Musculoskeletal and connective tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Tumor reopened after radiation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (Unspecified) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Peripheral motor neutropathy | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Seizure | Nervous system disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Bladder spasm | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Renal colic | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Urinary hesitancy | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Urinary urgency | Renal and urinary disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Dyspareunia | Reproductive system and breast disorders | CTCAE (Unspecified) | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Pelvic pressure | Reproductive system and breast disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Scrotal pain | Reproductive system and breast disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Skin tingling | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Waters | Washington University School of Medicine | 314-747-7236 | m.r.waters@wustl.edu |
| Sep 12, 2025 |
| Prot_SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG003 | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
|
|
| OG002 | Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG003 | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
|
|
| OG002 | Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG003 | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
|
|
| OG002 | Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG003 | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
|
|
|
| OG001 | Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG002 | Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG003 | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
|
|
|
| OG001 | Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG002 | Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG003 | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
|
|
|
| OG001 | Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG002 | Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG003 | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
|
|
|
| OG001 | Dose Level 2: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG002 | Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG003 | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
|
|
| OG002 |
| Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG003 | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
|
|
| OG002 | Dose Level 3: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
| OG003 | Dose Level -1: Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy (IMPT) |
|
|
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