Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to explore and compare the efficacy of Cetuximab (ERBITUX®) added to two concurrent chemoradiotherapy platforms of different intensity in locally advanced head and neck cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Cetuximab+FHX | Experimental | Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. |
|
| B: Cetuximab + PX | Experimental | Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Drug | 250mg/m2(day 1, weekly x 10); |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 1 years |
| Progression Free Survival (PFS) | Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years. | 2 years |
| Objective Response Rate to Induction | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Everett E Vokes, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | A: Cetuximab+FHX | Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 5-FU | Drug | 600 mg/m2/day; days 0-5 (120 h total) every other week x 5 |
|
| Hydroxyurea | Drug | 500 mg PO BID, days 0-5 every other week x 5 |
|
| Twice-daily radiation | Radiation | 150 cGy per fraction, days 1-5, every other week x 5 (total duration 10 weeks) |
|
| Cisplatin | Drug | 100 mg/m2, week 1 and 4 on day 1 (or 2) |
|
| Accelerated fraction radiotherapy with concomitant boost | Radiation | 72 Gy/42 F/6 W (3-D or IMRT based). Total duration 7 weeks. |
|
| Post-Induction (8 weeks) |
| Objective Response Rate to CRT | Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination. | From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks |
| Residual Lymph Node Disease | Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (>1.5 cm) or focally abnormal lymph node. | Up to 10 weeks |
| FG001 | B: Cetuximab + PX | Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A: Cetuximab+FHX | Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7) |
| BG001 | B: Cetuximab + PX | Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7) |
| 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 | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Progression Free Survival (PFS) | Kaplan-Meier estimate of PFS at 1 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Posted | Number | 95% Confidence Interval | Probability (%) | 1 years |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression Free Survival (PFS) | Time from randomization until disease progression or death from any cause. Kaplan-Meier estimate of PFS at 2 years. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. | Posted | Number | 95% Confidence Interval | Probability (%) | 2 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Time from randomization until death from any cause. Kaplan-Meier estimate of OS at 2 years. | Posted | Number | 95% Confidence Interval | Probability (%) | 2 years |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate to Induction | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Posted | Count of Participants | Participants | Post-Induction (8 weeks) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Objective Response Rate to CRT | Response to CRT was assessed by determining whether there was evidence of residual disease in the primary site via radiographic and clinical examination. | Posted | Count of Participants | Participants | From date of chemoradiotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Residual Lymph Node Disease | Response to CRT was also assessed by determining if there was evidence of residual lymph node disease by neck dissection, if warranted by the presence of any radiographically large (>1.5 cm) or focally abnormal lymph node. | Posted | Count of Participants | Participants | Up to 10 weeks |
|
24 months
Not provided
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 | A: Cetuximab+FHX | Cetuximab [250mg/m2 (day 1, weekly x10)] + FHX (5-FU [CI: 600mg/m2/day; days 0-5 (120h total) every other week x5], Hydroxyurea [500 mg PO BID, days 0-5 (=11 doses), every other week x5] and twice-daily radiation [150 cGy per fraction - days 1-5, every other week x5 (70-72 Gy total dose)]). Total duration is 10 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7) | 14 | 57 | 7 | 57 | 57 | 57 |
| EG001 | B: Cetuximab + PX | Cetuximab [250 mg/m2 (day 1, weekly x7)] + PX (Cisplatin [100mg/m2 (week 1 & 4 on day 1 (or 2))], Accelerated fraction radiotherapy with concomitant boost [AFX-CB (72 Gy/42 F/6 W) (3-D or IMRT based)]). Total duration: 7 weeks. Cetuximab: Cetuximab - Arm A:250mg/m2(day 1, weekly x 10); Cetuximab - Arm B:250mg/m2(day 1, weekly x 7) | 9 | 53 | 14 | 53 | 53 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mucositis oral | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| G-tube placement | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Malnourished | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Presyncopal episode | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight loss | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Hemoglobin increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| White blood cell decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dermatitis radiation | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Nervous system disorders - Other, specify | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Pain | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infections and infestations - Other, specify | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Everett E Vokes, MD | University of Chicago | (773) 702-9306 | evokes@medicine.bsd.uchicago.edu |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D005472 | Fluorouracil |
| D006918 | Hydroxyurea |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|