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| ID | Type | Description | Link |
|---|---|---|---|
| NCT01390584 | Registry Identifier | ClinicalTrials.gov | |
| U01CA079778 | U.S. NIH Grant/Contract | View source | |
| U01CA080098 | U.S. NIH Grant/Contract | View source |
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slow accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine, dacarbazine, cyclophosphamide, etoposide, procarbazine hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells. Comparing results of imaging procedures, such as PET scans and CT scans, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II clinical trial studies how well chemotherapy based on PET/CT scan works in treating patients with stage I or stage II Hodgkin lymphoma.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study.
Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are then assigned to an intervention arm according to fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT) results (negative vs positive).
NOTE: *HIV-positive patients whose 18FDG-PET/CT scans are positive after two courses of induction ABVD receive 4 courses of standard BEACOPP followed by INRT.
Patients undergo 18FDG-PET scans at baseline, and within 8-10 days after 2 courses of ABVD induction chemotherapy. Patients also undergo 18FDG-PET/CT** scan within 3-8 weeks after completion of 4 courses of BEACOPP and 6 courses of ABVD, and 3 months after completion of INRT.
NOTE: **If PET/CT remains positive, then a biopsy may be performed if medically appropriate or clinically feasible at the discretion of the treating physician. If biopsy is positive, patients will be followed for survival and secondary malignancies or new primaries.
Patients may undergo blood sample collection for correlative studies.
After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABVD + INRT | Experimental | Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses. PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment. ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks. |
|
| ABVD + BEACOPP + INRT | Experimental | Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses. PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment. BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxorubicin | Drug | IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival Rate | Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. | Assessed at 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Are PET Negative After Induction Treatment | Assessed at end of Cycle 2 | |
| Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment | Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. |
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Inclusion Criteria:
Histologically proven classical Hodgkin lymphoma subclassified according to the World Health Organization (WHO) Classification of Tumors, 4th edition (2008)
Patients must have clinical stage IA, IB, IIA, or IIB disease
Patients must have a mediastinal mass > 0.33-cm maximum intrathoracic diameter on standing postero-anterior chest x-ray or measuring > 10 cm in its largest diameter on axial CT images
Bone marrow biopsy is required
ECOG performance status 0-2
ANC ≥ 1,000/μL
Platelet count ≥ 100,000/μL
Hemoglobin ≥ 10 g/dL
Serum creatinine ≤ 2 mg/dL
Direct bilirubin ≤ 2 mg/dL
AST/ALT ≤ 2 times upper limit of normal
Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
LVEF by ECHO or MUGA normal unless thought to be disease related
DLCO ≥ 60% with no symptomatic pulmonary disease unless thought to be disease related
Patients with a history of intravenous drug abuse, or any behavior associated with an increased risk of HIV infection, should be tested for exposure to the HIV virus, and an HIV test is required for entry on this protocol
HIV-positive patients are eligible if they have CD4 counts ≥ 400/mm³ and are on concurrent antiretrovirals
Concurrent antiretroviral therapy for HIV-positive patients (CD4 counts ≥ 400/mm³) allowed
Exclusion Criteria:
Nodular lymphocyte-predominant Hodgkin lymphoma
Pregnant or nursing
"Currently active" second malignancy other than non-melanoma skin cancers
Prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma
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| Name | Affiliation | Role |
|---|---|---|
| Ranjana Advani, MD | Stanford University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Stanford | California | 94305-5824 | United States | ||
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center |
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
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This study was activated on April 2, 2012, accrued its first patient on May 24, 2013, and closed on January 24, 2014 with a final accrual of 6 patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABVD + INRT | Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses. PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment. ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Step 1: Induction Tx (ABVD Then PET/CT) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
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| Bleomycin | Drug | IV |
|
|
| Vinblastine | Drug | IV |
|
|
| PET | Diagnostic Test | fludeoxyglucose F 18 Imaging exam |
|
|
| INRT | Radiation | selective external radiation therapy |
|
| Dacarbazine | Drug | IV |
|
|
| Etoposide | Drug | IV |
|
|
| Cyclophosphamide | Drug | May be given orally, IV push, or by IV infusion |
|
|
| Vincristine | Drug | IV |
|
|
| Procarbazine | Drug | PO |
|
|
| Prednisone | Drug | PO |
|
|
| Assessed at 36 months |
| Complete Response (CR) Rate After Induction Treatment | Complete response (CR) is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. | Assessed at end of Cycle 2 |
| Overall Survival | Overall survival is defined as the time from study entry to death or date last known alive. | Assessed at 36 months |
| Sites of Relapse Following Combined Modality Treatment | Assessed at 3, 12, 18, 24 and 36 months after INRT |
| Serum and Plasma Banking | To bank serum and plasma at baseline and follow-up time point to assess the prognostic value of various markers, such as but not limited to, SCD30, IL10, CCL17, CCL22, and MDC. | Baseline and post cycle 2 |
| Biomarker Assessment Using Tissue Microarrays (TMAs) | To create TMAs from patient tumor blocks for future biomarker assessment including but not limited to bcl-2, FOXP3, and macrophage content. | Baseline and relapse/progression |
| The Association Between Thymus and Activation-related Chemokine (TARC) Levels and PET-CT Findings as Well as 3-year PFS | To measure serum TARC levels pre-treatment and after two cycles of ABVD and evaluate the associations between TARC levels and PET-CT findings as well as 3-year PFS. | Baseline and cycle 2 for TARC assessments; 3 years for PFS |
| Reading |
| Pennsylvania |
| 19612-6052 |
| United States |
| FG001 | ABVD + BEACOPP + INRT | Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses. PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment. BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks. |
| FG002 | Induction ABVD | Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Step 2: ABVD or BEACOPP Then INRT |
|
Only eligible and treated patients are included.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A (ABVD + INRT) | Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses. PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment. ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks. |
| BG001 | Arm B (ABVD + BEACOPP + INRT) | Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses. PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment. BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks. |
| 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, Continuous | Median | Full Range | 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 | Progression-free Survival Rate | Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. | Only eligible and treated patients are included in this analysis | Posted | Number | 95% Confidence Interval | proportion of participants | Assessed at 36 months |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Proportion of Patients Who Are PET Negative After Induction Treatment | Only eligible and treated patients are included in this analysis | Posted | Number | 90% Confidence Interval | proportion of participants | Assessed at end of Cycle 2 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment | Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. | Only patients who are PET positive are included in this analysis | Posted | Number | 90% Confidence Interval | proportion of participants | Assessed at 36 months |
| ||||||||||||||||||||||||||||||
| Secondary | Complete Response (CR) Rate After Induction Treatment | Complete response (CR) is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy. | Only eligible and treated patients are included in this analysis | Posted | Number | 90% Confidence Interval | proportion of participants | Assessed at end of Cycle 2 |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is defined as the time from study entry to death or date last known alive. | Only eligible and treated patients are included in this analysis | Posted | Median | 95% Confidence Interval | months | Assessed at 36 months |
| ||||||||||||||||||||||||||||||
| Secondary | Sites of Relapse Following Combined Modality Treatment | The study was terminated early due to slow accrual. Relapse data were not collected. | Posted | Assessed at 3, 12, 18, 24 and 36 months after INRT |
| ||||||||||||||||||||||||||||||||||
| Secondary | Serum and Plasma Banking | To bank serum and plasma at baseline and follow-up time point to assess the prognostic value of various markers, such as but not limited to, SCD30, IL10, CCL17, CCL22, and MDC. | The study was terminated early due to slow accrual. Biomarker data were not collected. | Posted | Baseline and post cycle 2 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Biomarker Assessment Using Tissue Microarrays (TMAs) | To create TMAs from patient tumor blocks for future biomarker assessment including but not limited to bcl-2, FOXP3, and macrophage content. | The study was terminated early due to slow accrual. Biomarker data were not collected. | Posted | Baseline and relapse/progression |
|
| ||||||||||||||||||||||||||||||||
| Secondary | The Association Between Thymus and Activation-related Chemokine (TARC) Levels and PET-CT Findings as Well as 3-year PFS | To measure serum TARC levels pre-treatment and after two cycles of ABVD and evaluate the associations between TARC levels and PET-CT findings as well as 3-year PFS. | The study was terminated early due to slow accrual. TARC data were not collected. | Posted | Baseline and cycle 2 for TARC assessments; 3 years for PFS |
|
|
Assessed every 4 weeks while on treatment and for 30 days after the end of treatment
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Step 1: Induction Treatment | Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses. PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). Patients will be assigned to Step 2 treatments (either ABVD + INRT or BEACOPP + INRT) depending on the scan results (negative or positive). | 0 | 6 | 5 | 6 | 6 | 6 |
| EG001 | Step 2: ABVD + INRT | ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks. | 0 | 4 | 3 | 4 | 4 | 4 |
| EG002 | Step 2: BEACOPP + INRT | BEACOPP + INRT: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks. | 0 | 1 | 1 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Chills | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Fever | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Allergic reaction | Immune system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | CTCAE 4.0 | Systematic Assessment |
| |
| Carbon monoxide diffusing capacity decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE 4.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
| |
| Superficial thrombophlebitis | Vascular disorders | CTCAE 4.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG-ACRIN Biostatistics Center | 617-632-3012 | eatrials@jimmy.harvard.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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D001761 | Bleomycin |
| D014747 | Vinblastine |
| D000072078 | Positron Emission Tomography Computed Tomography |
| D003606 | Dacarbazine |
| D005047 | Etoposide |
| D011034 | Podophyllotoxin |
| D003520 | Cyclophosphamide |
| D014750 | Vincristine |
| D011344 | Procarbazine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| 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 |
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D017705 | Lignans |
| D001593 | Benzyl Compounds |
| D001555 | Benzene Derivatives |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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