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| ID | Type | Description | Link |
|---|---|---|---|
| ET-B-028-06 | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
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| Name | Class |
|---|---|
| PharmaMar | INDUSTRY |
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The purpose of this study is to evaluate the safety and efficacy of trabectedin for the treatment of localized (non-metastatic) myxoid / round cell liposarcoma (malignant tumor derived from primitive or embryonal lipoblastic cells).
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multicenter (when more than one hospital or medical school team work on a medical research study) study of trabectedin for the treatment of localized myxoid / round cell liposarcoma (MRCL). Trabectedin will be given at 1.5 milligram per meter square (mg/m^2) over a 24-hour intravenous (iv) infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles along with dexamethasone 20 mg iv which will be given within 30 minutes before start of each trabectedin iv infusion. Participants whose myxoid/round cell liposarcoma (MRCL) do not progress at the end of the neoadjuvant treatment will be followed every 6 weeks for disease progression or until 6 months post definitive surgery, in the absence of unacceptable toxicity and/or disease progression. Efficacy will be assessed by determining the pathologic Complete Response (pCR) rate assessed in the tumor surgical specimen by a central pathology review. Participants' safety will be monitored throughout the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trabectedin | Experimental | Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) will be given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv will also be administered within 30 minutes before start of each trabectedin infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabectedin | Drug | Trabectedin 1.5 mg/m^2 over a 24-hour iv infusion every 3 weeks for a minimum of 3 and a maximum of 6 cycles of trabectedin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pathological Complete Response (pCR) | Complete pathological response is complete disappearance of the tumor tissue up to the molecular level. | Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST) | The objective tumor response is defined as the percentage of participants achieving partial response (PR) on tumor response assessed by RECIST. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coeur d'Alene | Idaho | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21642514 | Derived | Gronchi A, Bui BN, Bonvalot S, Pilotti S, Ferrari S, Hohenberger P, Hohl RJ, Demetri GD, Le Cesne A, Lardelli P, Perez I, Nieto A, Tercero JC, Alfaro V, Tamborini E, Blay JY. Phase II clinical trial of neoadjuvant trabectedin in patients with advanced localized myxoid liposarcoma. Ann Oncol. 2012 Mar;23(3):771-776. doi: 10.1093/annonc/mdr265. Epub 2011 Jun 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trabectedin | Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Dexamethasone | Drug | Dexamethasone 20 mg iv will be administered within 30 minutes before start of each trabectedin iv infusion |
|
| Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery. |
| Park Ridge |
| Illinois |
| United States |
| Iowa City | Iowa | United States |
| Boston | Massachusetts | United States |
| Bourdeaux | France |
| Lyon | France |
| Villejuif | France |
| Mannheim | Germany |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trabectedin | Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Percentage of Participants With Pathological Complete Response (pCR) | Complete pathological response is complete disappearance of the tumor tissue up to the molecular level. | Participants who received at least one cycle of trabectedin and have adequate pre and post trabectedin pathologic specimens available. Six participants were non evaluable for pCR assessment. | Posted | Number | percentage of participants | Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery. |
|
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| Secondary | Percentage of Participants With Objective Tumor Response Based on Response Evaluation Criteria In Solid Tumors (RECIST) | The objective tumor response is defined as the percentage of participants achieving partial response (PR) on tumor response assessed by RECIST. The PR is at least 30 percent decrease in sum of the longest diameter of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. | Participants who received at least one cycle of trabectedin and have at least one post baseline disease assessment. | Posted | Number | percentage of participants | Every 6 weeks until disease progression (up to Week 33) or 6 months post surgery. |
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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 | Trabectedin | Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion. | 6 | 29 | 28 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version 6.1 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA version 6.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 6.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 6.1 | Non-systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA version 6.1 | Non-systematic Assessment |
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| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA version 6.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 6.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 6.1 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Reflux gastritis | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Infusion site pain | General disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Oedema | General disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Hepatotoxicity | Hepatobiliary disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 6.1 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA version 6.1 | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA version 6.1 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA version 6.1 | Non-systematic Assessment |
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| Injection site infection | Infections and infestations | MedDRA version 6.1 | Non-systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA version 6.1 | Non-systematic Assessment |
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| Thrombosis in device | Injury, poisoning and procedural complications | MedDRA version 6.1 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA version 6.1 | Non-systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA version 6.1 | Non-systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA version 6.1 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA version 6.1 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA version 6.1 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA version 6.1 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Thrombophlebitis superficial | Vascular disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 6.1 | Non-systematic Assessment |
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| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 6.1 | Non-systematic Assessment |
|
Before submitting the paper or abstract or disclose information to public concerning trabectedin (YONDELIS®), PharmaMar must be provided of 15 days in case of abstract and 30 days in case of full paper, to review and approve the publication to assure that confidential and proprietary data are protected. Primary authorship for publication is hold by the coordinating investigator of this project. Following authors will be named according to the number of patients treated under this protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Specialist, Clinical Oncology | PharmaMar SA, Av de los Reyes 1 Mine Industrial Estate, 28770 Colmenar Viejo, Madrid, Spain | +34 91 646-6087 |
| ID | Term |
|---|---|
| D018208 | Liposarcoma, Myxoid |
| D008080 | Liposarcoma |
| ID | Term |
|---|---|
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
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| ID | Term |
|---|---|
| D000077606 | Trabectedin |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D004149 | Dioxoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| Title | Measurements |
|---|---|
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|