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Slow accrual and loss of sponsor
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Primary goal of the study is to assess the overall survival of the addition of hypofractionated image guided radiotherapy concurrently with Docetaxel and cisplatin. Survival will be assessed at 1 year from the date of study enrollment to date of death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | Chemotherapy only |
|
| 2 | Active Comparator | Chemotherapy and hypofractionated image guided radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel and cisplatin | Drug | Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV repeated every 21 days for 2 additional cycles. For patients randomized to group 1, the chemotherapy is identical to that administered for the first 2 cycles |
| Measure | Description | Time Frame |
|---|---|---|
| 1-Year Overall Survival | Overall survival is assessed at 1 year from the date of study enrollment to date of death. | Baseline to death from any cause, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall PFS and CT Rate | Overall PFS and CT rate is assessed response with PET and CT. Toxicity of addition of high dose focused RT to systemic therapy.Late (>90 day) radiotherapy toxicity will be assessed with RTOG/EORTC late RT toxicity guidelines | >90 days |
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Inclusion Criteria:
Age 18 years or older
Life expectancy > 6 months
Histologically or cytologically confirmed diagnosis of NSCLC
Patients with AJCC stage IV cancer with distant metastases and without malignant pleural or pericardial effusion at diagnosis and before start of study
Primary and regional nodal disease that is encompassable in a reasonable radiotherapy portal:
Patients with 1-5 sites of disease and amenable to RT therapy as seen on standard imaging (CT, MRI, bone scan, PET scan)
Unidimensionally measurable disease (based on RECIST) is desirable but not strictly required.
Patients with brain metastases are allowed as long as they meet all other inclusion criteria. Brain metastases must be treated with whole brain radiotherapy and stereotactic radiosurgery or surgical resection followed by whole brain radiotherapy.
ECOG performance status <2
No prior RT to currently involved tumor sites
Baseline peripheral neuropathy < grade 1
Room air saturation (SaO2) > 90%
Patients must have normal organ and marrow function
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Signed Informed consent
Inclusion of Women and Minorities
RT: Patient must have a completed treatment plan approved by the protocol review team
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Everett E Vokes, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
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Funding was withdrawn before conclusions were reached so the study was terminated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemo Only | Chemotherapy only |
| FG001 | Chemo and Radiation | Chemotherapy and hypofractionated image guided radiotherapy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Docetaxel and cisplatin Plus Hypofractionated Radiotherapy | Radiation | Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV for 2 cycles along with hypofractionated radiotherapy to all known sites of disease |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Chemo Only | Chemotherapy only |
| BG001 | Chemo and Radiation | Chemotherapy and radiotherapy |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| 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 | 1-Year Overall Survival | Overall survival is assessed at 1 year from the date of study enrollment to date of death. | The study was terminated before conclusions were reached so no data was analyzed. | Posted | Baseline to death from any cause, 1 year |
|
| ||||||||||||||||||||||
| Secondary | Overall PFS and CT Rate | Overall PFS and CT rate is assessed response with PET and CT. Toxicity of addition of high dose focused RT to systemic therapy.Late (>90 day) radiotherapy toxicity will be assessed with RTOG/EORTC late RT toxicity guidelines | The study was terminated before conclusions were reached so no data was analyzed. | Posted | >90 days |
|
|
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The adverse event data were not collected due to the study termination
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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 | Chemo Only | Chemotherapy only | 0 | 0 | 0 | 0 | ||
| EG001 | Chemo and Radiation | Chemotherapy and hypofractionated image guided radiotherapy | 0 | 0 | 0 | 0 |
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Funding was withdrawn before conclusions were reached so the study was terminated and no data was collected and analyzed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sang Mee Lee | Department of Health Studies, University of Chicago | 773-834-6765 | slee@health.bsd.uchicago.edu |
| 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 |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| >=65 years |
|
| Male |
|