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This observational study will evaluate the efficacy and safety of different capecitabine based chemotherapies, alone or in combination with other therapies, as first line treatment of metastatic colorectal cancer in participants during everyday clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic Colorectal Carcinoma (mCRC) Participants | Newly diagnosed mCRC participants, who will receive first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, will be observed. The choice of therapy is based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also do not specify any treatment regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | First line capecitabine based oral tablet treatment in line with the effective Summary of Product Characteristics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-free Survival (PFS) | PFS was assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and is defined as the time from the first dose of indicated treatment to disease progression (PD) or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. Participants without post-baseline tumor assessments were conservatively censored on the date of first study medication, which is PFS was assigned a value of 1 day. PD: at least 20 percent (%) increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm); progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method. | Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254 |
| PFS by Therapeutic Regimens | PFS was assessed using RECIST v1.1 and is defined as the time from the first dose of indicated treatment to PD or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm; progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method. | Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1 | Overall response is defined as a complete response (CR) or a partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. Participants were evaluated for tumor response per RECIST v1.1 and assessed by computed tomography (CT) or magnetic resonance imaging (MRI):CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions.PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with newly diagnosed colorectal cancer who have started first-line capecitabine based chemotherapy alone or in combination with other therapies.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szent Margit Hospital | Budapest | 1032 | Hungary | |||
| Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metastatic Colorectal Carcinoma (mCRC) Participants | Newly diagnosed metastatic colorectal carcinoma (mCRC) participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Chemotherapy | Drug | First line chemotherapy according to effective official Summary of Product Characteristics. The study protocol does not specify any particular therapy. |
|
| Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254 |
| Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1 | Clinical benefit was defined as having a confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST v1.1.CR: complete disappearance of all target lesions and non-target disease,with the exception of nodal disease.All nodes,both target and non-target, must decrease to normal (short axis <10 mm).No new lesions.PR: >=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes,while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters while on study.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions,or presence of new lesions. | Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254 |
| Percentage of Participants Who Underwent Metastasectomy | Metastasectomy is the surgical removal of metastases, which are secondary cancerous growths that have spread from cancer originating in another organ in the body. | Baseline up to 1254 days |
| Mean Duration of Capecitabine Therapy | Baseline up to 1254 days |
| Percentage of Participants With Dose Modification of Capecitabine | Baseline up to 1254 days |
| Budapest |
| 1076 |
| Hungary |
| Semmelweis Egyetem, II. Belgyógyászati Klinika | Budapest | 1088 | Hungary |
| Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika | Budapest | 1125 | Hungary |
| Fövárosi Önkormányzat uzsoki utcai Kórház | Budapest | 1145 | Hungary |
| Kenezy Korhaz Rendelointezet | Debrecen | 4031 | Hungary |
| Petz Aladar Megyei Oktato Korhaz | Győr | 9024 | Hungary |
| Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek | Gyula | 5700 | Hungary |
| Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont | Kecskemét | 6000 | Hungary |
| Pest Megyei Flor Korhaz; Oncology | Kistarcsa | 2143 | Hungary |
| Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly | Miskolc | 3501 | Hungary |
| Josa Andras Korhaz; Dept of Oncoradiology | Nyíregyháza | 4400 | Hungary |
| Pécsi Tudományegyetem Áok; Onkoterapias Intezet | Pécs | 7623 | Hungary |
| Szent Lázár Kórház | Salgótarján | 3100 | Hungary |
| Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika | Szeged | 6720 | Hungary |
| Tolna Megyei Onkormanyzat Balassa Janos Korhaz | Szekszárd | 7100 | Hungary |
| Dr. Bugyi Istvan Korhaz | Szentes | 6600 | Hungary |
| Szent Gyorgy Korhaz;Fejer Megyei | Székesfehérvár | 8000 | Hungary |
| Vas Megyei Markusovszky Korhaz X; Oncoradiology | Szombathely | 9700 | Hungary |
| Szent Borbala Korhaz | Tatabanuya | 2800 | Hungary |
| Veszprem Megyei Csolnoky; Ferenc Korhaz | Veszprém | 8200 | Hungary |
| Zala megyei Önkormányzat Kórház és Rendelõintézet | Zalaegerszeg | 8900 | Hungary |
| COMPLETED |
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| NOT COMPLETED |
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|
Intent to treat (ITT) population included all enrolled participants who provided evaluable data for efficacy variables.
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| ID | Title | Description |
|---|---|---|
| BG000 | mCRC Participants | Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| 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 | Median Progression-free Survival (PFS) | PFS was assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and is defined as the time from the first dose of indicated treatment to disease progression (PD) or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. Participants without post-baseline tumor assessments were conservatively censored on the date of first study medication, which is PFS was assigned a value of 1 day. PD: at least 20 percent (%) increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm); progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method. | ITT Population | Posted | Median | 95% Confidence Interval | Days | Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254 |
|
|
| |||||||||||||||||||||||||
| Primary | PFS by Therapeutic Regimens | PFS was assessed using RECIST v1.1 and is defined as the time from the first dose of indicated treatment to PD or death, whichever occurred first. Participants who did not progress or died while being followed were censored on the date of the last visit. PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm; progression of existing non-target lesions; or presence of new lesions. Median PFS was estimated using Kaplan-Meier method. | ITT Population. Here, number (n)= number of participants evaluable for the specified therapeutic regimen. | Posted | Median | 95% Confidence Interval | Days | Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1 | Overall response is defined as a complete response (CR) or a partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart. Participants were evaluated for tumor response per RECIST v1.1 and assessed by computed tomography (CT) or magnetic resonance imaging (MRI):CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm). No new lesions.PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. | ITT population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1 | Clinical benefit was defined as having a confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST v1.1.CR: complete disappearance of all target lesions and non-target disease,with the exception of nodal disease.All nodes,both target and non-target, must decrease to normal (short axis <10 mm).No new lesions.PR: >=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes,while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters while on study.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions,or presence of new lesions. | ITT Population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254 |
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Underwent Metastasectomy | Metastasectomy is the surgical removal of metastases, which are secondary cancerous growths that have spread from cancer originating in another organ in the body. | ITT Population. Here, N (number of participants analyzed) indicates the total number of participants who provided evaluable data for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline up to 1254 days |
|
| ||||||||||||||||||||||||||
| Secondary | Mean Duration of Capecitabine Therapy | ITT Population. Here, N (number of participants analyzed) indicates the total number of participants who provided evaluable data for this outcome measure. | Posted | Mean | Standard Deviation | Days | Baseline up to 1254 days |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Dose Modification of Capecitabine | ITT Population. | Posted | Number | Percentage of participants | Baseline up to 1254 days |
|
|
Baseline up to Day 1254
Safety Population included all enrolled participants.
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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 | mCRC Participants | Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen. | 55 | 882 | 140 | 882 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Heart failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bowel movement irregularity | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Large intestine perforatio | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombosis mesenteric vessel | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Peripheral neuropathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Cutaneous symptom | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndroma | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Nephrostomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| thrombosis | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013812 | Therapeutics |
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|
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| Units | Counts |
|---|---|
| Participants |
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