| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00947 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 59109 | Other Identifier | Wake Forest University Health Sciences |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase II trial is studying the side effects and how well giving oxaliplatin or mitomycin C directly into the abdomen after surgery works in treating patients with tumors of the appendix. Drugs used in chemotherapy, such as oxaliplatin and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
PRIMARY OBJECTIVES:
I. To compare the toxicity profiles within 4 weeks of surgery of oxaliplatin and mitomycin C delivered via Hyperthermic Intraperitoneal Chemotherapy in patients with peritoneal surface malignancies from primary appendiceal tumors.
SECONDARY OBJECTIVES:
I. To compare the time to progression in patients treated with oxaliplatin vs. mitomycin C delivered via Hyperthermic Intraperitoneal Chemotherapy for surface malignancies from primary appendiceal tumors.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients undergo surgical cytoreduction and receive mitomycin C by hyperthermic intraperitoneal chemotherapy (HIPEC).
Arm II: Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC.
After completion of study treatment, patients are followed up at 6, 12, 18, 24, 30, and 36 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (mitomycin C) | Experimental | Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC. |
|
| Arm II (oxaliplatin) | Experimental | Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mitomycin C | Drug | Given by HIPEC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments | If a patient has a grade 3 or 4 standard hematologic toxicity (leukopenia, thrombocytopenia, and neutropenia), the patient will be considered to be an event. The observed rates of the 2 treatments will be the primary outcome, and the rates will be analyzed using a 2-sided chi-square test. | Within 4 weeks of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years | Time to first progression unless the patient's resection status is R2b or 2c, regardless of toxicity or response to study drug, assessed up to 3 years | |
| The Difference in Percentage of Overall Survival Between the Two Treatment Arms up to 3 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Levine | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States | ||
| UPMC Hillman Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Mitomycin C) | Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC. mitomycin C: Given by HIPEC therapeutic conventional surgery: Undergo surgery quality-of-life assessment: Ancillary studies hyperthermic intraperitoneal chemotherapy: Undergo HIPEC |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| oxaliplatin | Drug | Given by HIPEC |
|
|
| therapeutic conventional surgery | Procedure | Undergo surgery |
|
| quality-of-life assessment | Other | Ancillary studies |
|
|
| hyperthermic intraperitoneal chemotherapy | Drug | Undergo HIPEC |
|
| Interval between surgery and death or date of last contact, assessed up to 3 years |
| Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G) | The FACT-G (Functional Assessment of Cancer Therapy - General) consists of 27 core items assessing patient well-being in four components: Physical (7 items), Social/Family (7 items), Emotional (6 items), and Functional (7 items). Items are rated on a five-point scale: 0-"not at all", 1- "a little bit", 2-"somewhat", 3- "quite a bit" and 4-"very much". The score of each component is the mean times the number of items in the component. The range of the physical, social/family, and functional components I 0-28 and the range of the emotional component is 0-24. The sum of the component scores creates the overall score which has a range of 0-108. For all component scores and overall score, the higher the score the better the QOL. | Throughout study completion, up to 3 years |
| Pittsburgh |
| Pennsylvania |
| 15232 |
| United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Arm II (Oxaliplatin) |
Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC. oxaliplatin: Given by HIPEC therapeutic conventional surgery: Undergo surgery quality-of-life assessment: Ancillary studies hyperthermic intraperitoneal chemotherapy: Undergo HIPEC |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Mitomycin C) | Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC. mitomycin C: Given by HIPEC therapeutic conventional surgery: Undergo surgery quality-of-life assessment: Ancillary studies hyperthermic intraperitoneal chemotherapy: Undergo HIPEC |
| BG001 | Arm II (Oxaliplatin) | Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC. oxaliplatin: Given by HIPEC therapeutic conventional surgery: Undergo surgery quality-of-life assessment: Ancillary studies hyperthermic intraperitoneal chemotherapy: Undergo HIPEC |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | 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 | The Difference in the Number of Grade 3 or 4 Hematologic Toxicities (Leukopenia, Thrombocytopenia, and Neutropenia) Between the Mitomycin C and Oxaliplatin Treatments | If a patient has a grade 3 or 4 standard hematologic toxicity (leukopenia, thrombocytopenia, and neutropenia), the patient will be considered to be an event. The observed rates of the 2 treatments will be the primary outcome, and the rates will be analyzed using a 2-sided chi-square test. | Posted | Number | number of patients with toxicities | Within 4 weeks of surgery |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | The Difference in Percentage of Disease-free Survival Between the Two Treatment Arms up to 3 Years | Posted | Mean | Standard Error | disease-free survival rate (%) | Time to first progression unless the patient's resection status is R2b or 2c, regardless of toxicity or response to study drug, assessed up to 3 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | The Difference in Percentage of Overall Survival Between the Two Treatment Arms up to 3 Years | Posted | Mean | Standard Error | overall survival rate (%) | Interval between surgery and death or date of last contact, assessed up to 3 years |
|
| |||||||||||||||||||||||||||||||
| Secondary | Quality of Life as Assessed by Functional Assessment of Cancer Therapy: General (FACT-G) | The FACT-G (Functional Assessment of Cancer Therapy - General) consists of 27 core items assessing patient well-being in four components: Physical (7 items), Social/Family (7 items), Emotional (6 items), and Functional (7 items). Items are rated on a five-point scale: 0-"not at all", 1- "a little bit", 2-"somewhat", 3- "quite a bit" and 4-"very much". The score of each component is the mean times the number of items in the component. The range of the physical, social/family, and functional components I 0-28 and the range of the emotional component is 0-24. The sum of the component scores creates the overall score which has a range of 0-108. For all component scores and overall score, the higher the score the better the QOL. | Posted | Mean | Standard Error | units on a scale | Throughout study completion, up to 3 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 | Arm I (Mitomycin C) | Patients undergo surgical cytoreduction and receive mitomycin C by HIPEC. mitomycin C: Given by HIPEC therapeutic conventional surgery: Undergo surgery quality-of-life assessment: Ancillary studies hyperthermic intraperitoneal chemotherapy: Undergo HIPEC | 1 | 58 | 51 | 58 | 58 | 58 |
| EG001 | Arm II (Oxaliplatin) | Patients undergo surgical cytoreduction and receive oxaliplatin by HIPEC. oxaliplatin: Given by HIPEC therapeutic conventional surgery: Undergo surgery quality-of-life assessment: Ancillary studies hyperthermic intraperitoneal chemotherapy: Undergo HIPEC | 1 | 61 | 54 | 61 | 61 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low WBC | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| low Platelets | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Low Hemoglobin | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Anorexia | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Obstruction, GI: Small bowel | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Low ANC | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| hyperglycemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hypocalcemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hyponatremia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hypokalemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hypoalbuminemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hyperbilirubinemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| serum glutamic pyruvic transaminase | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hypophosphatemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| serum glutamic oxaloacetic transaminase | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Dehydration | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Confusion | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Mood alteration: Agitation | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Anxiety | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Depression | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Pain: Abdomen | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Acidosis | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Infection Bladder | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| creatine phosphokinase | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Pain: Chest/thorax | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| disseminated intravascular coagulation | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Prolonged QTc interval | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| functional obstruction of bowel | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Malabsorption | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Death not associated with CTCAE term: Multi-organ failure | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Pain: Muscle | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| infection associated with Lymphopenia | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Pain: Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| International Normalized Ratio of prothrombin time | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Pain: Scrotum | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Urinary with low grade neutropenia | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Mental status | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Hemorrhage, GI: Lower GI | Vascular disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Hemorrhage/bleeding associated with surgery, intra-operative or postoperative | Vascular disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Abdomen | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Peritoneal cavity | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Cardiac troponin I | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Fistula, GI: Abdomen | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Leak (including anastomotic), GI: Leak | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Leak (including anastomotic), GI: Small bowel | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Necrosis, GI: Small bowel | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Lung Infection with high grade neutropenia | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Pelvis | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Wound | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Infection with unknown ANC: Peritoneal cavity | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy): Left-sided | Musculoskeletal and connective tissue disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Prolonged intubation after pulmonary resection (>24 hrs after surgery) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Infection with high grade neutropenia | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Blood Infection with high grade neutropenia | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low WBC | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| low Platelets | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Low Hemoglobin | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Anorexia | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Proteinuria | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Hypertension | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Neuropathy: sensory | Cardiac disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Low ANC | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Taste alteration | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Insomnia | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Dermatology/Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Sweating | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| hyperglycemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hypocalcemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hypomagnesemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hyponatremia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hypokalemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Bicarbonate serum-low | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hypoalbuminemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hyperbilirubinemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| serum glutamic pyruvic transaminase | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hypophosphatemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0 | Systematic Assessment |
| |
| serum glutamic oxaloacetic transaminase | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hypermagnesemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hyperkalemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| hypernatremia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Dysphagia | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Fever without neutropenia | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Constitutional Symptoms - Other | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Cardiac Arrhythmia - Other | Cardiac disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Edema: limb | Vascular disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Edema: trunk/genital | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Edema: viscera | Vascular disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Dehydration | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Confusion | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Mood alteration: Agitation | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Anxiety | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Depression | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Distension bloating, abdominal | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Pain: Abdomen | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Pain: Joint | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Ascites (non-malignant) | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Conduction abnormality/atrioventricular heart block | Cardiac disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Pain: Back | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Infection Bladder | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Pain Bladder | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Right ventricular dysfunction | Cardiac disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Wound complication, non-infectious | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Hematoma | Blood and lymphatic system disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Hiccoughs (hiccups, singultus) | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| hypertriglyceridemia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| functional obstruction of bowel | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Watery eye (epiphora, tearing) | Eye disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Pain: Muscle | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Pain: Neuralgia/peripheral nerve | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Pain Oral cavity | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| International Normalized Ratio of prothrombin time | Investigations | CTCAE (3.0 | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia: Sinus bradycardia | Cardiac disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Pain: Stomach | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia: Supraventricular tachycardia | Cardiac disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Pain: Urethra | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Urinary with low grade neutropenia | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Hemorrhage GU: Urinary | Vascular disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Leak (including anastomotic), GI: Pancreas | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Cognitive disturbance | General disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Leak (including anastomotic), GI: Leak | Gastrointestinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Mucositis/stomatitis Oral cavity | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils: Wound | Infections and infestations | CTCAE (3.0 | Systematic Assessment |
| |
| Infection with unknown ANC Lung (pneumonia) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Prolonged chest tube drainage or air leak after pulmonary resection | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0 | Systematic Assessment |
| |
| Intra-operative injury: NERVES: Peripheral sensory | General disorders | CTCAE (3.0 | Systematic Assessment |
|
The worst adverse event of each type was recorded for the course of treatment.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Edward Levine | Wake Forest University Health Sciences | 336-716-2763 | elevine@wakehealth.edu |
| ID | Term |
|---|---|
| D001063 | Appendiceal Neoplasms |
| ID | Term |
|---|---|
| D002430 | Cecal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016685 | Mitomycin |
| D000077150 | Oxaliplatin |
| D000084262 | Hyperthermic Intraperitoneal Chemotherapy |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D056831 | Coordination Complexes |
| D017024 | Chemotherapy, Adjuvant |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D006979 | Hyperthermia, Induced |
Not provided
Not provided
| >=65 years |
|
| 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 |
|
|
|
|
|