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| Name | Class |
|---|---|
| Sanofi-Synthélabo (Schweiz) AG | UNKNOWN |
The purpose of this study is to determine the pathological complete tumor response rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine+Oxaliplatin | Experimental | Eligible participants received capecitabine 1000 milligrams per square meter (mg/m^2) on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Capecitabine is available as 50 mg and 500 mg tablets. It will be administered as a 1000mg/m^2 bid orally on Days 1-14, and at a dose of 825mg/m^2 bid on Days 22-35 and 43-56. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pathological Complete Tumor Response | Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response). | Up to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sphincter-preservation | Percentage of participants with sphincter-preservation is reported. | Up to Week 16 |
| Number of Participants With Marked Laboratory Abnormalities |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Basel | 4031 | Switzerland | ||||
Not provided
A total of 60 participants were enrolled in this study conducted from 30 March 2005 to 28 November 2006 at 6 centers in Switzerland.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Capecitabine + Oxaliplatin | Eligible participants received capecitabine 1000 milligrams per square meter (mg/m^2) on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all the participants who received at least one dose of any of the study treatments and who had a baseline assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Capecitabine + Oxaliplatin | Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Tumor Response | Pathological complete tumor response was defined as grade 3 or 4 in the histological grading of regression according to Dworak classification. Grade 0 is no regression; Grade 1 is dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2 is dominantly fibrotic changes with few tumor cells or groups; Grade 3 is defined as very few (difficult to find microscopically) tumor cells in fibrotic tissue with or without mucous substance; Grade 4 is defined as no tumor cells, only fibrotic mass (total regression or response). | The intent to treat (ITT) population included all participants, who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 16 |
|
Up to Week 16
AE is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalisation or prolongation of hospitalisation or results in disability/incapacity, and congenital anomaly/birth defect.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Capecitabine + Oxaliplatin | Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roche Trial Information Hotline | F. Hoffmann-La Roche AG | +41 61 6878333 | global.trial_information@roche.com |
Not provided
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Oxaliplatin | Drug | Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m^2/d intravenously on Day 1 and 50mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy up to Week 9 followed by surgery period. |
|
|
Number of participants with marked laboratory abnormalities is reported.
| Up to Week 16 |
| Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer | R0 resection was defined as complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation as confirmed by pathology after pre-operative chemotherapy plus capecitabine + oxaliplatin therapy. | Up to Week 16 |
| Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes | Downstaging of primary tumor (T) and/or lymph nodes (N) was defined as decrease by 1 point in T-value and/or N-value (comparing at screening and after treatment). It was assessed by colonoscopy, pathology, endosonography of rectum, chest X-ray, abdominopelvic Computed Tomography and Magnetic Resonance Imaging. Staging for tumor are: TX (primary tumor cannot be assessed), T0 (no evidence of primary tumor), Tis (carcinoma in situ), T1 (tumor invades submucosa), T2 (tumor invades muscularis propria), T3 (tumor invades through muscularis propria into subserosa/into non-peritonealized pericolic/perirectal tissues, T4 (tumor directly invades other organs or structures). Staging for lymph nodes are: NX (regional lymph nodes cannot be assessed), N0 (no regional lymph node metastasis), N1 (metastasis in 1 to 3 regional lymph nodes), N2 (metastasis in 4 or more regional lymph nodes). | From screening to Week 16 |
| Percentage of Participants With Pathological Incomplete Tumor Response | Pathological incomplete tumor response was defined as grade 1 or 2 in the histological grading of regression according to Dworak grading of regression. Pathological incomplete tumor response rate, Grade 1: dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2: dominantly fibrotic changes with few tumor cells or groups (easy to find) were assessed. | Up to Week 16 |
| Number of Participants With Any Adverse Events and Serious Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. | Up to Week 16 |
| Chur |
| 7000 |
| Switzerland |
| Lucerne | 6004 | Switzerland |
| Sankt Gallen | 9007 | Switzerland |
| Zurich | 8037 | Switzerland |
| Zurich | 8063 | Switzerland |
| years |
|
| Gender | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants With Sphincter-preservation | Percentage of participants with sphincter-preservation is reported. | ITT population included all participants, who received at least one dose of study drug. Two participants from the ITT population did not undergo surgery (one died, one withdrew consent). | Posted | Number | Percentage of participants | Up to Week 16 |
|
|
|
| Secondary | Number of Participants With Marked Laboratory Abnormalities | Number of participants with marked laboratory abnormalities is reported. | Safety population included all the participants who received at least one dose of any of the study treatments and who had a baseline assessment. | Posted | Number | Participants | Up to Week 16 |
|
|
|
| Secondary | Percentage of Participants With Resection (R0) in Participants With T4 Rectal Cancer | R0 resection was defined as complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation as confirmed by pathology after pre-operative chemotherapy plus capecitabine + oxaliplatin therapy. | The ITT consists of all included participants, who received at least one dose of study drug. Five participants from ITT population with T4 rectal cancer underwent surgery. | Posted | Number | Percentage of participants | Up to Week 16 |
|
|
|
| Secondary | Percentage of Participants With Downstaging of Primary Tumor and/or Lymph Nodes | Downstaging of primary tumor (T) and/or lymph nodes (N) was defined as decrease by 1 point in T-value and/or N-value (comparing at screening and after treatment). It was assessed by colonoscopy, pathology, endosonography of rectum, chest X-ray, abdominopelvic Computed Tomography and Magnetic Resonance Imaging. Staging for tumor are: TX (primary tumor cannot be assessed), T0 (no evidence of primary tumor), Tis (carcinoma in situ), T1 (tumor invades submucosa), T2 (tumor invades muscularis propria), T3 (tumor invades through muscularis propria into subserosa/into non-peritonealized pericolic/perirectal tissues, T4 (tumor directly invades other organs or structures). Staging for lymph nodes are: NX (regional lymph nodes cannot be assessed), N0 (no regional lymph node metastasis), N1 (metastasis in 1 to 3 regional lymph nodes), N2 (metastasis in 4 or more regional lymph nodes). | ITT population included all participants, who received at least one dose of study drug. | Posted | Number | Percentage of participants | From screening to Week 16 |
|
|
|
| Secondary | Percentage of Participants With Pathological Incomplete Tumor Response | Pathological incomplete tumor response was defined as grade 1 or 2 in the histological grading of regression according to Dworak grading of regression. Pathological incomplete tumor response rate, Grade 1: dominant tumor mass with obvious fibrosis and/or vasculopathy; Grade 2: dominantly fibrotic changes with few tumor cells or groups (easy to find) were assessed. | ITT population included all participants, who received at least one dose of study medication. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Week 16 |
|
|
|
| Secondary | Number of Participants With Any Adverse Events and Serious Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in participants or clinical investigation participants administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. | Safety population included all the participants who received at least one dose of any of the study treatments and who had a baseline assessment. | Posted | Number | Participants | Up to Week 16 |
|
|
|
| 8 |
| 60 |
| 57 |
| 60 |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Anal Haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Subileus | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Proctitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Painful Defaecation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Temperature Intorlerance | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Weight Decrease | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Peripheral Sensory Neropathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hand and Foot Syndrome | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | 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.
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| Title | Measurements |
|---|---|
|
| Leucocytes total |
|
| Neutrophils |
|
| Basophils |
|
| Eosinophils |
|
| Monocytes |
|
| Lymphocytes |
|
| Platelets |
|
| ASAT/SGOT |
|
| ALAT/SGPT |
|
| Serum albumin |
|
| Total protein |
|
| Serum creatinine |
|
| Glucose |
|
| Sodium |
|
| Potassium |
|
| Calcium |
|
| Title | Measurements |
|---|
|