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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003980-38 |
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This single arm study will assess the efficacy and safety of treatment with Xeloda plus standard pelvic radiotherapy in participants with locally advanced rectal cancer. Eligible participants will receive Xeloda 825mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. The anticipated time on study treatment is < 3 months, and the target sample size is < 100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine | Experimental | Capecitabine orally twice daily plus standard radiotherapy for 5 weeks, followed by surgery within 6 weeks after completion of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard radiotherapy | Radiation | Administered as prescribed according to normal clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pathological Complete Response | Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures. | Up to 11 weeks (assessed at the time of post-treatment surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment) | Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banská Bystrica | 975 17 | Slovakia | ||||
A total of 62 participants were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Capecitabine | Capecitabine 825 milligrams per meter square (mg/m^2) orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Capecitabine | Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Pathological complete response was defined as the absence of viable tumor cells in the tumor specimen, including regional lymph nodes determined with standard histological procedures. | Participants with available data. | Posted | Number | percentage of participants | Up to 11 weeks (assessed at the time of post-treatment surgery) |
|
|
Up to 15 weeks
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 | Capecitabine | Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular fibrillation | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800-821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Capecitabine [Xeloda] | Drug | 825 milligrams per meter square (mg/m^2) orally twice daily for 5 weeks. |
|
|
| Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy) |
| Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment) | Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD. | Up to 15 weeks (assessed 1 month after surgery) |
| Percentage of Participants With Adverse Events | An adverse event was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment. | Up to 15 weeks |
| Bratislava |
| 833 10 |
| Slovakia |
| Withdrawal by Informed Consent |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Percentage of Participants With Response to Treatment Assessed 4-6 Weeks After the Completion of Radiochemotherapy (Complete Response, Partial Remission or No Response to the Treatment) | Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD. | Participants with available data. | Posted | Number | percentage of participants | Up to 11 weeks (assessed 4-6 weeks after the completion of radiochemotherapy) |
|
|
|
| Secondary | Percentage of Participants With Response to the Treatment Assessed 1 Month After Surgery (Complete Response, Partial Remission or No Response to the Treatment) | Complete response was defined as the disappearance of all target and non-target lesions. Partial remission was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of target lesions, taking as reference the baseline SLD, or the persistence of 1 or more non-target lesions. No response to treatment was defined as neither sufficient shrinkage to qualify for partial remission nor sufficient increase to qualify for progressive disease, compared to the baseline SLD. | Participants with available data. | Posted | Number | percentage of participants | Up to 15 weeks (assessed 1 month after surgery) |
|
|
|
| Secondary | Percentage of Participants With Adverse Events | An adverse event was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment. | All enrolled participants. | Posted | Number | percentage of participants | Up to 15 weeks |
|
|
|
| 4 |
| 62 |
| 49 |
| 62 |
| Diarrhea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hemorrhoidal inflammation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (19.0) | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Cyst in the liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (19.0) | 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.
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|