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| ID | Type | Description | Link |
|---|---|---|---|
| B9E-BX-JHSQ | Other Identifier | Eli Lilly and Company |
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The purpose of the study is to evaluate the response rate of patients with non small lung cancer to gemcitabine in combination with radiotherapy. The tolerability and safety of this combination will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemcitabine + Cisplatin | Experimental | Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5). Cisplatin: 80 mg/m2, IV, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine | Drug | 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5) |
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| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response at End of Treatment | Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progressive Disease | Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression. Patients who have not had disease progression will be censored at the date of the last follow-up visit. Patients dying because of reasons other than tumor progression are not included. | Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years); |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Aalst | 9300 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemcitabine + Cisplatin | Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5). Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| cisplatin | Drug | 80 mg/m2, IV, every 21 days x 5 cycles |
|
| radiation | Radiation | 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5 |
|
| Overall Survival | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. | Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years) |
| Safety of Induction Chemotherapy | A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported. Grade 3 events are severe and Grade 4 events are life-threatening. | every cycle (21 days) for 3 cycles (up to 10 weeks) |
| Safety of Chemo-radiotherapy | A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to NCI-CTC Version 2.0 grading scales. For specific radiation events, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation toxicity scale was used. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant acute Grade 3 and Grade 4 toxicities (worst severity) occurring during chemo-radiation and up to 49 days (8 weeks) after are reported. Grade 3 events are severe and Grade 4 events are life-threatening. | Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy |
| Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Charleroi | 6000 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gilly | 6060 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Haine-St.- Paul | 7100 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Herentals | 2200 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mechelen | 2800 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ottignies | 1340 | Belgium |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Turnhout | 2300 | Belgium |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemcitabine + Cisplatin | Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5). Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Basis for Pathological Diagnosis | Number | participants |
| |||||||||||||||||||||||
| Disease Stage | Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage IIIA - the cancer has spread to nearby tissue or spread to near by lymph nodes. Stage IIIB - cancer spread to opposite side of chest, more than one tumor within same lobe of lung. | Number | participants |
| ||||||||||||||||||||||
| Karnofsky Performance Status Scale | Classifies patients according to their functional impairment. Scores range from 0-100, the lower the score, the worse the survival for most serious illnesses. | Number | participants |
| ||||||||||||||||||||||
| Pathological Diagnosis | Number | participants |
| |||||||||||||||||||||||
| Time Since Diagnosis | Mean | Standard Deviation | months |
|
| 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 | Tumor Response at End of Treatment | Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. | All enrolled participants. | Posted | Number | participants | baseline to first follow-up visit (up to 8 weeks after end of chemo-radiation) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Time to Progressive Disease | Time to progressive disease is the time from the date of enrollment to the first date of documented disease progression. Patients who have not had disease progression will be censored at the date of the last follow-up visit. Patients dying because of reasons other than tumor progression are not included. | All enrolled participants. | Posted | Median | Full Range | months | Preliminary: baseline to measured progressive disease (up to 3.5 years); Final: baseline to measured progressive disease (up to 5 years); |
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. | All enrolled participants. | Posted | Median | Full Range | months | Preliminary: baseline to date of death from any cause (up to 3.5 years); Final: baseline to date of death from any cause (up to 5 years) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Safety of Induction Chemotherapy | A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 2.0 grading scales. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant Grade 3 and Grade 4 toxicities occurring during induction chemotherapy are reported. Grade 3 events are severe and Grade 4 events are life-threatening. | All enrolled participants. | Posted | Number | participants | every cycle (21 days) for 3 cycles (up to 10 weeks) |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Safety of Chemo-radiotherapy | A grading (severity) scale is provided for each adverse event term. Toxicities were graded according to NCI-CTC Version 2.0 grading scales. For specific radiation events, Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer late radiation toxicity scale was used. Grades range from 0 (none) to 5 (death). Number of participants with clinically significant acute Grade 3 and Grade 4 toxicities (worst severity) occurring during chemo-radiation and up to 49 days (8 weeks) after are reported. Grade 3 events are severe and Grade 4 events are life-threatening. | All enrolled participants receiving chemo-radiotherapy (Cycle 4). | Posted | Number | participants | Cycles 4 and 5 up to 8 weeks after the end of chemo-radiotherapy |
|
|
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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 | Gemcitabine + Cisplatin | Gemcitabine: 1250 mg/m2, IV, day 1 and day 8 q 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5) Cisplatin: 80 mg/m2, IV, q 21 days x 5 cycles Radiation: 63 Gy in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5 | 13 | 49 | 48 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Hyperthermia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Tracheal haemorrhage | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
Enrollment was stopped early due to difficulties with patient recruitment. Given the number of missing/unknown tumor assessments, care should be taken when interpreting the primary outcome measure. An identified error was corrected in the results.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 1-800-545-5979 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D055585 | Physical Phenomena |
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| 100 - Normal no complaints; no evidence of disease |
|
| Other Pathological Diagnosis |
|
| Squamous Cell |
|
| Title | Measurements |
|---|---|
|
| Progressive Disease |
|
| Unknown |
|
| Missing |
|
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