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| ID | Type | Description | Link |
|---|---|---|---|
| LYMHD0002 | Other Identifier | OnCore |
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RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: This phase 2 trial is studying how well giving combination chemotherapy together with low-dose radiation therapy works in treating patients with stage I or stage IIA Hodgkin's lymphoma.
OBJECTIVES:
Participants receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30 to 60 minutes weekly on weeks 1 and 5; doxorubicin IV and vinblastine IV over 5 minutes once weekly on weeks 1, 3, 5, and 7; oral prednisone every other day on weeks 1 to 8; vincristine IV, and bleomycin IV over 5 minutes once weekly on weeks 2, 4, 6, and 8; and etoposide IV over 60 minutes on days 1 and 2 of weeks 3 and 7. Prior to protocol amendment, participants were assigned to treatment on the basis of tumor size (< 5 cm vs 5 to 10 cm), with only the participants with larger tumors receiving RT. Beginning 2 to 3 weeks after completion of chemotherapy, participants in the +RT group will receive low-dose radiotherapy 5 days a week for approximately 3 weeks. Subsequent to amendment, all participants received RT.
Participants are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stanford V-C + Low-dose Radiotherapy | Experimental | "Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide. Radiotherapy = 20 Gy modified involved field radiotherapy |
|
| Stanford V-C only | Experimental | "Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vincristine | Drug | 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression. | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Complete Response | The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as "complete regression of all palpable and radiographic demonstrable disease" by computed tomography (CT) scan or positron emission tomography-CT (PET-CT). | 5 weeks |
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INCLUSION CRITERIA:
Diagnosis of previously untreated stage I or IIA Hodgkin's lymphoma, eligible subtypes
Age ≥ 18 years and ≤ 70 years
Granulocytes ≥ 2 x 10e6/µL
Platelets ≥ 150 x 10e6/µL
Bilirubin ≤ 2.5 mg/dL
Serum creatinine ≤ 2 mg/dL
Patients > 50 years or those with a history of cardiac disease should have an ejection fraction ≥ 50%
All scans, X-rays, laboratory tests must be performed within 6 weeks of enrollment
Pathologic material reviewed at Stanford University
Evaluation by Stanford Medical Oncology and Radiation Oncology with review at the Hodgkin's Disease Staging Conference
Written informed consent
EXCLUSION CRITERIA:
Lymphocytic predominance Hodgkin's disease
Prior treatment for Hodgkin's disease
Mediastinal mass equal to or greater than one-third the maximum intrathoracic diameter on a standing posteroanterior chest x-ray
Any lymph node mass > 10 cm in greatest trans-axial diameter
Two or more extranodal sites of disease
Constitutional (B) symptoms present at diagnosis
Prior or concurrent malignancies within 5 years (EXCEPTION: basal cell carcinoma of the skin)
Any medical contraindication to the planned treatment, including:
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| Name | Affiliation | Role |
|---|---|---|
| Ranjana H Advani, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States | ||
| Kaiser Permanente Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stanford V-C + Low-dose Radiotherapy | "Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Patients with tumors 5 to 10 cm were to be assigned to concurrent radiotherapy, and participants with tumors less than 5 cm were initially planned to not receive radiotherapy.
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| Cyclophosphamide | Drug | 650 mg/m², on week 1 and 5 |
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| Doxorubicin | Drug | 25 mg/m², on week 1, 3, 5, 7 |
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| Prednisone | Drug | 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy |
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| Bleomycin | Drug | 5 u/m² intravenously (IV) on week 2, 4, 6, 8 |
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| Etoposide | Drug | 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44) |
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| Low-dose radiotherapy (RT) | Radiation | 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen. |
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| Early Treatment-related Toxicity | Early treatment-related toxicity was assessed as the number of treatment-related, non-serious adverse events that occurred during treatment or within 30 days of the completion of treatment. | Within 30 days of treatment |
| Late Treatment-related Toxicity | Late treatment-related toxicity was assessed as the overall number of late-appearing toxicities (ie, related adverse events, after treatment completion) including but not limited to diagnosis of a 2nd cancer; hypothyroidism; infertility; pulmonary toxicity; or cardiac toxicity, at up to 16 years from date of diagnosis. | 16 years |
| Second Hodgkin's Disease Progression | Second Hodgkin's disease progression is reported as the number of participants experiencing 2 instances of progression of the underlying Hodgkin's disease, assessed at up to 16 years from date of diagnosis. | 16 years |
| Overall Survival (OS) | Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation. | 16 years |
| Survival at 5 and 10 Years | Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints. | 5 and 10 years |
| Vallejo |
| California |
| 94589 |
| United States |
| FG001 | Stanford V-C Only | "Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
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| COMPLETED |
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| NOT COMPLETED |
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Prior to amendment, participants with tumor size < 5 cm received Stanford V-C only. Subsequent to amendment, all participants received Stanford V-C + low-dose radiotherapy (RT)
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| ID | Title | Description |
|---|---|---|
| BG000 | Stanford V-C + Low-dose Radiotherapy | "Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen. |
| BG001 | Stanford V-C Only | "Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
|
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Progression-free Survival (PFS) | Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression. | Does not include those participants whose treatment was significantly modified due to accidental injury; or who were lost-to-follow-up. | Posted | Number | percentage of participants | up to 3 years |
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| |||||||||||||||||||||||||||||
| Secondary | Frequency of Complete Response | The frequency of complete response (CR) is reported as the number (proportion) of subjects in complete response, as assessed during weeks 4 to 5 of chemotherapy. Per protocol, CR is defined as "complete regression of all palpable and radiographic demonstrable disease" by computed tomography (CT) scan or positron emission tomography-CT (PET-CT). | Participants, for whom a PET-CT scan was not conducted in week 4 to 5 of treatment, were not included. | Posted | Count of Participants | Participants | 5 weeks |
| |||||||||||||||||||||||||||||||
| Secondary | Early Treatment-related Toxicity | Early treatment-related toxicity was assessed as the number of treatment-related, non-serious adverse events that occurred during treatment or within 30 days of the completion of treatment. | Posted | Number | treatment-related adverse events | Within 30 days of treatment |
| ||||||||||||||||||||||||||||||||
| Secondary | Late Treatment-related Toxicity | Late treatment-related toxicity was assessed as the overall number of late-appearing toxicities (ie, related adverse events, after treatment completion) including but not limited to diagnosis of a 2nd cancer; hypothyroidism; infertility; pulmonary toxicity; or cardiac toxicity, at up to 16 years from date of diagnosis. | Posted | Number | treatment-related adverse events | 16 years |
| ||||||||||||||||||||||||||||||||
| Secondary | Second Hodgkin's Disease Progression | Second Hodgkin's disease progression is reported as the number of participants experiencing 2 instances of progression of the underlying Hodgkin's disease, assessed at up to 16 years from date of diagnosis. | Data to confirm Hodgkin's disease 2nd progression was not available for some participants. | Posted | Count of Participants | Participants | 16 years |
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival was assessed at up to 16 years from date of diagnosis, and reported as the median years of survival with standard deviation. | Includes all participants, except those whose treatment was significantly modified due to accidental injury. Subjects who became lost-to-follow-up were censored at their last known value. | Posted | Median | Full Range | years | 16 years |
| ||||||||||||||||||||||||||||||
| Secondary | Survival at 5 and 10 Years | Survival at 5 and 10 years is expressed at the percentage of subjects known to remain alive at those timepoints. | For overall survival at 5 and 10 years, this analysis does not include those participants known to be alive, but whose diagnosis was less than 5 or 10 years prior to current date or last date known alive, respectively. | Posted | Count of Participants | Participants | 5 and 10 years |
|
16 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 | Stanford V-C + Low-dose Radiotherapy | "Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
"Low-dose radiotherapy (RT)" = 20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen. | 7 | 72 | 25 | 72 | 72 | 72 |
| EG001 | Stanford V-C Only | "Stanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.
| 0 | 4 | 2 | 4 | 4 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
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| Second cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
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| Crush injury, automobile accident | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Secondary to automobile accident |
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| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Fatigue/Malaise | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea and Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Metallic Taste in Mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Infection with grade 3 ANC grade 2 ATT (no hospitalization) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Oral Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Mild Oral Sensitivity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Oral Toxicity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Epigastric pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Acute Pulmonary Embolism | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Febrile Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Insomnia | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Tenderness at the PICC site | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Discomfort, burning & increased sensitivity | General disorders | CTCAE (4.0) | Systematic Assessment |
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| PICC line removed | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Peripheral Sensory Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Peripheral Motor Neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Mood Alteration | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Chest soreness and tightness | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fungal rash | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Rectal ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Blood spotting | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Gross hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Diaphoresis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Syncopal episode with brief loss of consciousness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Altered taste sensation | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Vein Pain | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain, bilateral arms | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain, inflammation of left arm above IV site | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Aches and pains | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain, axilla & breast | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Sorness in upper and lower extremities | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Myalgias | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Substernal chest pressure | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain, bone and muscle | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain, abdominal | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain, jaw | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain, hips and legs | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Gas pains | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Joint pains, back and hips | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Ache and heaviness in left arm | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Phlebitis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain, right groin | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Generalized achiness | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Flu-like symptoms | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain, related to PICC | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Muscle aches | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Pain, lower back | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Arthralgias | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Skin toxicity | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Swelling | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Weight loss | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica C Lam, BS | Stanford Univeristy Medical Center | 650-723-0437 | jclam11@stanford.edu |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D014750 | Vincristine |
| D014747 | Vinblastine |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| D001761 | Bleomycin |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D013812 | Therapeutics |
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| >=65 years |
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| Male |
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