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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005083-28 | EudraCT Number | ||
| CONCERT | Other Identifier | Bayer |
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This study is to assess sorafenib as second treatment for patients that have previously received only sunitinib as first-line treatment for advanced renal cell cancer, and who either responded and then progressed with sunitinib or were intolerant to sunitinib. This study is to assess if combining the usual dose of sorafenib (200mg twice-daily) with low dose interferon (3 million international unit (MIU) five times a week) can treat kidney cancer more effectively than the current approved dose alone and if it is safe. In addition, for patients that respond to treatment with sorafenib alone or in combination with interferon before progressing, patients may receive sorafenib alone at an increased dose of 300mg twice-daily, provided that toxicities are acceptable and at the discretion of the investigator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Experimental | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. |
|
| Sorafenib (Nexavar, BAY43-9006) + Interferon | Experimental | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | Drug | Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors [RECIST]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation. | From start of treatment of the first subject until 14 months later, assessed every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | Response Rate was the best tumor response (confirmed Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. | From start of treatment of the first subject until 14 months later, assessed every 8 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | State of Vienna | 1090 | Austria | |||
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| Label | URL |
|---|---|
| Click here and search for EudraCT infomation of Bayer Product | View source |
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A total of 24 subjects were screened; 16 were enrolled and randomized; 10 (63%) to sorafenib alone and 6 (37%) to sorafenib + interferon. All 16 randomized subjects received at least 1 dose of study drug and were included in the safety analysis population.
This study was conducted from 16 Apr 2008 to 26 Jun 2009 at 31 centers in 7 countries: France (11), Italy (6), Spain (5), Poland (4), Ireland (2), United Kingdom (2), and Austria (1). The planned enrollment was 120 subjects in the 2 treatment groups (60 subjects per group). The study was stopped early because of slow accrual.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sorafenib (Nexavar, BAY43-9006) | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. |
| FG001 | Sorafenib (Nexavar, BAY43-9006) + Interferon | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sorafenib (Nexavar, BAY43-9006) + Interferon | Drug | Sorafenib 400 mg (two 200 mg tablets) BID PO, continuously. IFN alpha-2a 3MIU FIW s.c., from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. |
|
| Time to Progression |
Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. |
| From start of treatment of the first subject until 14 months later, assessed every 8 Weeks |
| Duration of Response | Duration of Response was the time from date of first response (Complete Response [CR] or Partial Response [PR]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact. | From start of treatment of the first subject until 14 months later, assessed every 8 Weeks |
| Overall Survival | Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact. | From start of treatment of the first subject until 14 months later, assessed every 8 Weeks |
| Salzburg |
| 5020 |
| Austria |
| Avignon | 84000 | France |
| Bayonne | 64100 | France |
| Bordeaux | 33000 | France |
| Marseille | 13015 | France |
| Marseille | 13385 | France |
| Nantes | 44020 | France |
| Paris | 75014 | France |
| Paris | 75651 | France |
| Reims | 51100 | France |
| Strasbourg | 67000 | France |
| Toulouse | 31052 | France |
| Vandœuvre-lès-Nancy | 54000 | France |
| Dublin | Dublin | 24 | Ireland |
| Cork | Ireland |
| Aviano | Pordenone | 33081 | Italy |
| Legnago | Verona | 37045 | Italy |
| Naples | 80131 | Italy |
| Pavia | 27100 | Italy |
| Perugia | 06156 | Italy |
| Reggio Emilia | 42100 | Italy |
| Gdansk | 80-219 | Poland |
| Lublin | 20-090 | Poland |
| Warsaw | 04-141 | Poland |
| Wroclaw | 50 - 556 | Poland |
| Barcelona | Barcelona | 08035 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Madrid | Madrid | 28046 | Spain |
| Oviedo | Oviedo | 33006 | Spain |
| Pamplona | Pamplona | 31008 | Spain |
| Valencia | Valencia | 46009 | Spain |
| London | London | SW3 6JJ | United Kingdom |
| Northwood | Middlesex | HA6 2RN | United Kingdom |
| Newcastle upon Tyne | Tyne and Wear | NE4 6BE | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sorafenib (Nexavar, BAY43-9006) | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. |
| BG001 | Sorafenib (Nexavar, BAY43-9006) + Interferon | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. |
| 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 |
| ||||||||||||||||
| Memorial Sloane Kettering Cancer Center (MSKCC) score | The MSKCC score is a prognostic score obtained by adding 1 point for each of 5 risk factors: 1. Absence of prior nephrectomy, 2. Corrected serum calcium > 10 mg/dL, 3. Hemoglobin < lower limit of normal, 4. Lactate dehydrogenase (LDH) > 1.5X upper limit of normal, 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≥ 2 (The ECOG PS is a scale that measures how cancer affects a patient. The scale ranges from 0 [fully active] to 5 [dead]). A Low MSKCC score is 0 risk factors, Intermediate is 1-2 risk factors, and Poor is 3-5 risk factors. | 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 | Progression-free Survival (PFS) was the time from the first dose of combination therapy to disease progression (radiological or clinical, whichever is earlier, according to Response Evaluation Criteria in Solid Tumors [RECIST]) or death (if death occurs before progression is documented). PFS for subjects without tumor progression or death at the time of analysis were censored at the date of last tumor evaluation. | Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats. | Posted | From start of treatment of the first subject until 14 months later, assessed every 8 weeks |
|
| ||||||||||||||||||||||
| Secondary | Response Rate | Response Rate was the best tumor response (confirmed Complete Response [CR], Partial Response [PR] or Stable Disease [SD]) observed according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. | Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats. | Posted | From start of treatment of the first subject until 14 months later, assessed every 8 Weeks |
|
| ||||||||||||||||||||||
| Secondary | Time to Progression | Time to progression was the time from treatment start date to disease progression. Subjects without progression at the time of analysis were censored at their last date of tumor evaluation. | Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats. | Posted | From start of treatment of the first subject until 14 months later, assessed every 8 Weeks |
|
| ||||||||||||||||||||||
| Secondary | Duration of Response | Duration of Response was the time from date of first response (Complete Response [CR] or Partial Response [PR]) to the date when Progressive Disease (PD) is first documented or to the date of death, whichever occurs first. Subjects still having CR or PR at the time of analysis were censored at their last date of last contact. | Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats. | Posted | From start of treatment of the first subject until 14 months later, assessed every 8 Weeks |
|
| ||||||||||||||||||||||
| Secondary | Overall Survival | Overall Survival was the time from treatment start date to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact. | Efficacy analysis was not performed due to low accrual. For details, please see Limitation and Caveats. | Posted | From start of treatment of the first subject until 14 months later, assessed every 8 Weeks |
|
|
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Acronyms in Adverse Event section: not otherwise specified (NOS), Alanine transaminase (ALT), Aspartate transaminase (AST)
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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 | Sorafenib (Nexavar, BAY43-9006) | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously. | 5 | 10 | 9 | 10 | ||
| EG001 | Sorafenib (Nexavar, BAY43-9006) + Interferon | Sorafenib 400 mg (two 200 mg tablets) twice daily (bid) per os (po), continuously plus Interferon (IFN) alpha-2a 3 millions of international unit (MIU) five times a week (FIW) subcutaneous (s.c.), from Monday to Friday (total weekly dose 15 MIU) s.c., to start one week after commencing sorafenib. | 3 | 6 | 5 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection (documented clinically), bronchus | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, bone | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, back | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rhinitis | Immune system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Neutrophils | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Leukocytes | Blood and lymphatic system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypertension | Cardiac disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Weight loss | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Mucositis (functional/symptomatic), esophagus | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Mucositis (functional/symptomatic), oral cavity | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Mucositis (functional/symptomatic), pharynx | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Taste alteration | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection (documented clinically), bronchus | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection (documented clinically), dental-tooth | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dermal change | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Extremity-upper (function) | Musculoskeletal and connective tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Metabolic/lab - other | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Mood alteration, depression | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, back | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, chest/thorax NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, chest wall | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, abdomen NOS | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, head/headache | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, joint | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, bone | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Voice changes | Respiratory, thoracic and mediastinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hand-foot skin reaction | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dermatology - other | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Photosensitivity | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Libido | Reproductive system and breast disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Auditory/ear - ohter | Ear and labyrinth disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Fever | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Insomnia | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Constitutional symptoms - other | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dehydration | Gastrointestinal disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hematoma | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hemorrhage pulmonary, nose | Vascular disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection (documented clinically), bladder (urinary) | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Infection (documented clinically), mucosa | Infections and infestations | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| ALT | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| AST | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Pain, muscle | General disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | NCI-CTCAE v.3.0 | Non-systematic Assessment |
|
The study was terminated early by the Sponsor due to low accrual. No efficacy analyses were performed.
Protocol and PI clinical trial agreements.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D007372 | Interferons |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
Not provided
Not provided
| Male |
|
| intermediate MSKCC score |
|