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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA021115 | U.S. NIH Grant/Contract | View source | |
| E4298 | Other Identifier | Eastern Cooperative Oncology Group (ECOG) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor.
PURPOSE: Phase II trial to study the effectiveness of chemoembolization in treating patients who have primary liver cancer or metastases to the liver that cannot be surgically removed.
OBJECTIVES:
OUTLINE: Patients are stratified according to disease (hepatocellular carcinoma vs neuroendocrine hepatic metastases).
Patients undergo placement of a visceral arterial catheter. Patients receive doxorubicin, mitomycin, and cisplatin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only. Immediately following delivery of the chemoemulsion, particulate embolization is performed. The opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe.
In the absence of unacceptable toxicity, each involved lobe is treated separately a second time, in the same sequence, beginning 8 weeks after the last lobular chemoembolization. After completion of all protocol therapy, retreatment on study of either lobe is allowed for regrowth, recurrence, or new disease, provided at least 3 months have elapsed since the initial treatment of that lobe.
Patients are followed for 5 years.
PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study within 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hepatocellular carcinoma | Experimental | Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. |
|
| Neuroendocrine hepatic metastases | Experimental | Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression | Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) >=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions | Assessed every 3 months for 2 years, then every 6 months for 3 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | Clinical complete response was defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response was defined as >= 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. Tumor response was defined as complete response + partial response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith E. Stuart, MD | Beth Israel Deaconess Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Front Range Cancer Specialists | Fort Collins | Colorado | 80524 | United States | ||
| Baptist Cancer Institute - Jacksonville |
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Participants were recruited from ECOG membership institution between August 6, 1999 and September 15, 2006. The first patient was accrued on December 15, 1999.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hepatocellular Carcinoma | Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. |
| FG001 | Neuroendocrine Hepatic Metastases |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| doxorubicin | Drug | Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray). |
|
|
| mitomycin | Drug | Doxorubicin 30 mg, mitomycin 30 mg, and cisplatin 100 mg (all in powdered form) should be dissolved in 10-15 cc of contrast agent (such as isovue or optiray). |
|
|
| embolization | Procedure | Immediately following delivery of the chemoemulsion, particulate embolization is performed. The particulate embolic material is prepared on a separate table or tray, using absorbable gelatin sponge (Gelfoam, Upjohn, Kalamazoo, MI), in either powder or pledget form. Approximately 1 g of this temporary occlusive agent is dissolved in 20-30 cc of full-strength contrast with 2.4 cc of absolute alcohol. |
|
|
| Assessed every 6 weeks |
| Overall Survival | Overall survival was defined as time from registration to death from any causes. | Assessed every 3 months for 2 years, then every 6 months for 3 year. |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | United States |
| Veterans Affairs Medical Center - Atlanta (Decatur) | Decatur | Georgia | 30033 | United States |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60507 | United States |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
| Hematology and Oncology Associates | Chicago | Illinois | 60611 | United States |
| Veterans Affairs Medical Center - Lakeside Chicago | Chicago | Illinois | 60611 | United States |
| Mercy Hospital and Medical Center | Chicago | Illinois | 60616 | United States |
| Swedish Covenant Hospital | Chicago | Illinois | 60625 | United States |
| Hinsdale Hematology Oncology Associates | Hinsdale | Illinois | 60521 | United States |
| Midwest Center for Hematology/Oncology | Joliet | Illinois | 60432 | United States |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | United States |
| North Shore Oncology and Hematology Associates, Limited - Libertyville | Libertyville | Illinois | 60048 | United States |
| Hematology Oncology Associates - Skokie | Skokie | Illinois | 60076 | United States |
| Hematology/Oncology of the North Shore at Gross Point Medical Center | Skokie | Illinois | 60076 | United States |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | United States |
| Mercy Capitol Hospital | Des Moines | Iowa | 50307 | United States |
| CCOP - Iowa Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | 50309 | United States |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | 50314 | United States |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | 50316-2301 | United States |
| Medical Oncology and Hematology Associates - West Des Moines | West Des Moines | Iowa | 50266 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Carol G. Simon Cancer Center at Morristown Memorial Hospital | Morristown | New Jersey | 07962 | United States |
| Somerset Medical Center | Somerville | New Jersey | 08876 | United States |
| Overlook Hospital | Summit | New Jersey | 07902 | United States |
| Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
| St. Rita's Medical Center | Lima | Ohio | 45801 | United States |
| Fox Chase Cancer Center - Philadelphia | Philadelphia | Pennsylvania | 19111-2497 | United States |
| Albert Einstein Cancer Center | Philadelphia | Pennsylvania | 19141 | United States |
Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. |
| Eligible |
|
| Received Protocol Therapy (Treated) |
|
| Eligible and Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hepatocellular Carcinoma | Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. |
| BG001 | Neuroendocrine Hepatic Metastases | Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. |
| 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 |
| ||||||||||||||||
| 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 | Time to Progression | Time to progression was defined as time from embolization to documented disease progression. Patients without documented progression were censored at the time of the last documented disease evaluation or of the last treatment ended, whichever was more recent.Disease progression was defined as significant increase in size of lesions or appearance of new metastatic lesions. Specifically, 1) >=25% increase in the area of any malignant lesions greater than 2 cm² or in the sum of the products of the individual lesions in a given organ site; 2)>=50% increase in the size of the product of diameters if only one lesion is available for measurement and was less than or equal to 2 cm² in size at the initiation of therapy; 3)>=25% increase in the sum of the liver measurements below the costal margins and xyphoid; 4)Appearance of new malignant lesions | All eligible and treated patients | Posted | Median | 90% Confidence Interval | Months | Assessed every 3 months for 2 years, then every 6 months for 3 year. |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Tumor Response | Clinical complete response was defined as complete disappearance of all clinically detectable malignant disease for at least 4 weeks. Partial response was defined as >= 50% decrease in tumor size for at least 4 weeks without increase in size of any area of known malignant disease of greater than 25%, or appearance of new areas of malignant disease. Tumor response was defined as complete response + partial response. | all eligible and treated patients | Posted | Number | 90% Confidence Interval | Proportion of participants | Assessed every 6 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival was defined as time from registration to death from any causes. | all eligible and treated patients | Posted | Median | 90% Confidence Interval | Months | Assessed every 3 months for 2 years, then every 6 months for 3 year. |
|
|
Assessed every cycle (each chemo-embolization procedure is considered a cycle) while on treatment and for 30 days after the end of treatment.
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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 | Hepatocellular Carcinoma | Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. | 18 | 18 | 18 | 18 | ||
| EG001 | Neuroendocrine Hepatic Metastases | Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization. | 30 | 31 | 31 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Neutropenia (Neutrophils, decreased) | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombocytopenia (Platelets, decreased) | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Transfusion: pRBCs | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Supraventricular arrhythmias | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Acute vascular leak syndrome | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Cardiac-ischemia | Cardiac disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Operative injury of vein/artery | Injury, poisoning and procedural complications | CTCAE (2.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| PT | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hemorrhage with grade 3 or 4 platelets | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| GI-other | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Melena/GI bleeding | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Bilirubin | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hepatic enlargement | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Liver dysfunction/failure | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| SGOT | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| SGPT | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hepatic-other | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infection w/o neutropenia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Hypercholesterolemia | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Arachnoiditis | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Confusion | Psychiatric disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dizziness/lightheadedness | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Infection-other | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Tumor pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Leukopenia (Leukocytes, decreased) | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Neutropenia (Neutrophils, decreased) | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Thrombocytopenia (Platelets, decreased) | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Edema | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Fever | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| PT | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Diarrhea w/o prior colostomy | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Bilirubin | Investigations | CTCAE (2.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Hepatic pain | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Pain-other | General disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (2.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Statistician | ECOG Statistical Office | 617-632-3012 |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D009362 | Neoplasm Metastasis |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D010984 | Platinum |
| D004317 | Doxorubicin |
| D016685 | Mitomycin |
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
| 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 |
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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| Male |
|
|
|
|