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To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy.
Our principal objectives in this trial will be to determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU (oral capecitabine if 5FU is unavailable), oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy. If we can establish a T stage downstaging rate that is significantly better than 50% and if acute tolerance is acceptable, then we would consider this study as having provided sufficient pilot data to support including this approach as an arm in a multi-institution phase III trial. The long-term goal is improved overall control of disease by delivering better chemotherapy earlier.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant radiation followed by FOLFOX | Experimental | Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week. FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks). If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External beam radiation | Radiation |
| ||
| Oxaliplatin |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of T Stage Downstaging | T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT). | Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks) |
| Preoperative Gastrointestinal Morbidity | As measured by participants who experience grade 3 or higher gastrointestinal morbidity | Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Any Late Grade 3 or Higher Morbidity | Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks) | |
| Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity | 1 year (completion of all treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parag Parikh, 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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The study opened to participant enrollment on 11/10/2009 and closed to participant enrollment on 04/18/2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Neoadjuvant Radiation Followed by FOLFOX | Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week. FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks). If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
|
| Leucovorin | Drug |
|
| 5-FU | Drug |
|
|
| Capecitabine | Drug |
|
|
| Local Control |
| 30 months |
| Rate of Overall Control | 1 year |
| Rate of Locoregional Control | 1 year |
| Freedom From Disease Relapse | Kaplan-Meier projections. | 30 months |
| Determine Quality of Anorectal Function | Anorectal function was measured by the participant's response to the FACT-C questionnaire question "I have control of my bowels". The answers ranged from 0=not at all to 4=very much. | Up to 1 year |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Neoadjuvant Radiation Followed by FOLFOX | Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week. FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks). If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Clinical T stage |
| Number | participants |
| ||||||||||||||||||||||
| Clinical N stage |
| Number | participants |
| ||||||||||||||||||||||
| Clinical M stage |
| Number | participants |
|
| 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 | Rate of T Stage Downstaging | T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT). | Posted | Number | percentage of participants | Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks) |
|
|
| |||||||||||||||||||||||||||
| Primary | Preoperative Gastrointestinal Morbidity | As measured by participants who experience grade 3 or higher gastrointestinal morbidity | One patient was inevaluable for primary objectives because patient withdrew consent after completing radiation therapy, refused chemotherapy, and underwent a lesion resection 7 weeks after radiation therapy. | Posted | Number | participants | Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks) |
|
| |||||||||||||||||||||||||||
| Secondary | Incidence of Any Late Grade 3 or Higher Morbidity | One patient was inevaluable for primary objectives because patient withdrew consent after completing radiation therapy, refused chemotherapy, and underwent a lesion resection 7 weeks after radiation therapy. | Posted | Number | participants | Preoperative (mean time from start of radiation to surgery 17.3 weeks (SD +/- 2.9 weeks) |
|
| ||||||||||||||||||||||||||||
| Secondary | Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity | Posted | Number | participants | 1 year (completion of all treatment) |
|
| |||||||||||||||||||||||||||||
| Secondary | Local Control |
| Posted | Number | 95% Confidence Interval | percentage of participants | 30 months |
|
| |||||||||||||||||||||||||||
| Secondary | Rate of Overall Control | Posted | Number | percentage of participants | 1 year |
|
| |||||||||||||||||||||||||||||
| Secondary | Rate of Locoregional Control | Posted | Number | percentage of participants | 1 year |
|
| |||||||||||||||||||||||||||||
| Secondary | Freedom From Disease Relapse | Kaplan-Meier projections. | These include all cMO evaluable cases only. | Posted | Number | 95% Confidence Interval | percentage of participants | 30 months |
|
| ||||||||||||||||||||||||||
| Secondary | Determine Quality of Anorectal Function | Anorectal function was measured by the participant's response to the FACT-C questionnaire question "I have control of my bowels". The answers ranged from 0=not at all to 4=very much. | Participants who had an ostomy were not included in this outcome measure. Participants who did not complete FACT-C questionnaire at a specific timepoint were not included in that timepoint. | Posted | Count of Participants | Participants | Up to 1 year |
|
|
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Adverse events listed in the "Other" area have the word acute or late after the event name. Acute adverse events are followed from start of treatment until Day 90. Adverse events that occurred after Day 90 are referred to as late adverse events.
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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 | Neoadjuvant Radiation Followed by FOLFOX | Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week. FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks). If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days. | 4 | 79 | 79 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AST | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest pain | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema (axilla) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypercholesteremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| INR | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle spasm - bladder | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain, Dysuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Port-A-Cath Pain | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT (acute) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| ALT, SGPT (late) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT (acute) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT (late) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal pain (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Abdominal pain (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase (acute) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase (late) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity (late) | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anal incontinence (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anal incontinence (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia (acute) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia (late) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back pain (acute) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Back pain (late) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bladder pain (acute) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Buttock pain (acute) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chest pain (acute) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough (acute) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough (late) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine (acute) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine (late) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration (late) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness (acute) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness (late) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin (acute) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (acute) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (late) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: limb (acute) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: limb (late) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Erectile dysfunction (late) | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (acute) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (late) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever (acute) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever (late) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fistula, GI (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flatulence (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GI Leak (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hair loss/alopecia (acute) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Headache (acute) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Headache (late) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn/dyspepsia (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn/dyspepsia (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin (acute) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin (late) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI, Rectum (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI: melena (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hot flashes/flushes (acute) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperbilirubinemia (acute) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperbilirubinemia (late) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Hypercalcemia (late) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia (acute) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperglycemia (late) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia (acute) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperkalemia (late) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia (acute) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoalbuminemia (late) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia (acute) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypocalcemia (late) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoglycemia (acute) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia (acute) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypokalemia (late) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia (acute) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypomagnesemia (late) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia (acute) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyponatremia (late) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypophosphatemia (acute) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| INR (acute) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| INR (late) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Ileus, GI (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ileus, GI (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - UTI (acute) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils (acute) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1/2 neutrophils: abdomen (acute) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1/2 neutrophils: skin (late) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia (acute) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia (late) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Jaw pain (acute) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint pain (acute) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leak, GI (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leg pain (late) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukopenia (acute) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukopenia (late) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia (acute) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia (late) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - anxiety (acute) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - depression (acute) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration-anxiety (late) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration-depression (late) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic) (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic) (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle pain (acute) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness (late) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy-sensory (late) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory (acute) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (acute) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (late) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Nose bleed (acute) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| PTT (acute) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Pain: Dysuria (acute) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Perianal skin pain (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets (acute) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets (late) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching (acute) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation (acute) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation (late) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: dermatitis associated with radiation (acute) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: hand-foot skin reaction (acute) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rectal pain (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills (acute) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills (late) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Small bowel NOS obstruction (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating (acute) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism (acute) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urgency, GI (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary frequency/urgency (acute) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary frequency/urgency (late) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary retention (acute) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary retention (late) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss (acute) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss (late) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Wound complication, non-infectious (acute) | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Wound complication, non-infectious (late) | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Parag Parikh, M.D. | Washington University School of Medicine | 314-362-9703 | pparikh@radonc.wustl.edu |
| 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
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
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