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German Hodgkin Study Group Study HD16/HD17/HD18 Chemotherapy regimen G6C DRKS00003455 - Deutsche Hodgkin Studiengruppe: G6C Chemotherapiebogen

- 1/11/18 - 1 form, 5 itemgroups, 73 items, 1 language
Itemgroups: Form Header, Chemotherapy regimen, Laboratory prior to treatment start, Toxic side effects, Treatment changes
HD16 NCT Nr.: NCT00736320 HD16 for Early Stages - Treatment Optimization Trial in the First-line Treatment of Early Stage Hodgkin Lymphoma; Treatment Stratification by Means of FDG-PET. This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of Progression free survival (PFS). HD17 NCT Nr.: NCT01356680 HD17 for Intermediate Stages - Treatment Optimization Trial in the First-Line Treatment of Intermediate Stage Hodgkin Lymphoma.This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS). HD18 NCT Nr.: NCT00515554 HD18 for Advanced Stages in Hodgkins Lymphoma. This study is designed to test: in patients with negative positron-emission tomography (PET) after 2 cycles of BEACOPPesc chemotherapy: whether the number of cycles can be reduced without compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles) for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc chemotherapy by adding Rituximab improves PFS. Permission granted by: Andreas Engert, M.D. Chairman, German Hodgkin Study Group Professor for Internal Medicine Hematology & Oncology University Hospital of Cologne Department of Internal Medicine I Kerpener Str. 62 D-50924 Köln Phone: +49-221-478-5933/5966 Fax: +49-221-478-3778 a.engert@uni-koeln.de

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 11 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 11

- 24/5/17 - 1 form, 22 itemgroups, 135 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 10 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 10

- 24/5/17 - 1 form, 22 itemgroups, 135 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 9 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 9

- 24/5/17 - 1 form, 22 itemgroups, 135 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 8 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 8

- 24/5/17 - 1 form, 22 itemgroups, 135 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 7 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 7

- 24/5/17 - 1 form, 22 itemgroups, 135 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 6 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 6

- 24/5/17 - 1 form, 22 itemgroups, 139 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 4 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 4

- 24/5/17 - 1 form, 23 itemgroups, 136 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Circulating free plasma DNA - Blood Sampling, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 5 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 5

- 24/5/17 - 1 form, 22 itemgroups, 135 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 3 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 3

- 18/5/17 - 1 form, 22 itemgroups, 135 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 2 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 2

- 18/5/17 - 1 form, 24 itemgroups, 139 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, ECG, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Circulating free plasma DNA - Blood Sampling, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

CRFs Cabazitaxel Prostate Cancer DRKS00006520 NCT01308580 Cycle 1 - CRFs Cabazitaxel Prostate Cancer NCT01308580 Cycle 1

- 18/5/17 - 1 form, 24 itemgroups, 142 items, 1 language
Itemgroups: Visit Information, Vital Signs, Laboratory Tests Hematology, Laboratory Tests Biochemistry, Premedication, Investigational Product Administration - Prednisone, Investigational Product Administration - Cabazitaxel, Interruption - Cabazitaxel, Cabazitaxel Pharmacokinetic - Blood Sampling, Cabazitaxel Pharmacogenomic - Blood Sampling, Macroscopic Hematuria, Tumor Assessment - Target Lesion, Tumor Assessment - Non-target lesion, Tumor Assessment - New Lesion, Bone Scan, Tumor Markers, Cancer Pain Questionnaire, Disease Status, FACT P Questionnaire, FACT P Questionnaire - Physical Well-Being, FACT P Questionnaire - Social/ Family Well-Being, FACT P Questionnaire - Emotional Well-Being, FACT P Quesionnaire - Functional Well-Being, FACT P Questionnaire - Additional Concerns
Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen Other drug name: Jevtana® Study Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT01308580 Sponsor: Sanofi

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