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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA032102 | U.S. NIH Grant/Contract | View source | |
| S0220 | Other Identifier | SWOG |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Eastern Cooperative Oncology Group | NETWORK |
| American College of Surgeons | OTHER |
| North Central Cancer Treatment Group |
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RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining cisplatin and etoposide with radiation therapy may shrink the tumor so it can be removed by surgery. Giving docetaxel after surgery may kill any remaining tumor cells.
PURPOSE: This phase II trial is studying how well giving chemoradiotherapy together with cisplatin and etoposide followed by surgery and docetaxel works in treating patients with newly diagnosed Pancoast tumors, a type of non-small cell lung cancer.
OBJECTIVES:
OUTLINE:
Within 2-4 weeks after completion of induction chemoradiotherapy, patients undergo disease evaluation. Patients with no evidence of local or overall disease progression undergo a thoracotomy within 3-7 weeks. Patients who do not qualify for surgery proceed to consolidation chemotherapy within 3-8 weeks after chemoradiotherapy is complete.
Patients are followed at 4-6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etoposide, Cisplatin, Thoracic RT, Surgery, Docetaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | During induction:50 mg/m2,IV on Days 1, 8, 29 & 36. In any appropriate vehicle over 60 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Treating Patients With Stage IIB/IIIB Pancoast Tumors With a Regimen of Cisplatin and Etoposide Plus Concurrent Radiotherapy Followed by Surgical Resection Followed by Consolidation Therapy With Docetaxel. | Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen. | After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxel |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Only adverse events that are possibly, probably or definitely related to study drug are reported. | Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks. |
| Overall Survival |
Not provided
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer
Any of the following stages due to involvement of the superior sulcus:
Newly diagnosed
Primary bronchogenic
Must meet 1 of the following tumor involvement criteria:
No more than 1 parenchymal lesion in the same lung or in both lungs
No involvement of the following lymph node groups as determined by mediastinal exploration* (i.e., mediastinoscopy, mediastinotomy, thoracoscopy, or thoracotomy) within the past 42 days:
Single-level or multi-level ipsilateral or contralateral mediastinal nodal (N2 or N3) disease by mediastinoscopy, thoracoscopy, mediastinotomy, thoracotomy, or transbronchial Wang needle biopsy, regardless of whether enlarged nodes are visible or not on chest x-ray or CT scan
Supraclavicular (scalene) nodes
Left upper lobe tumors with left vocal cord paralysis by indirect laryngoscopy (presumes N2 nodes in the A-P window) NOTE: *Mediastinal exploration is not required for patients whose mediastinum is negative by both positron-emission tomography (PET) and CT scan
No pleural effusions except if 1 of the following criteria are met:
No pericardial effusions or superior vena cava syndrome
No brain metastases by CT scan or MRI
No evidence of distant metastatic disease by bone scan or PET
Must be a candidate for potential future pulmonary resection
PATIENT CHARACTERISTICS:
Age
Performance status
Zubrod 0-2
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Michael J. Kraut, MD | Providence Hospital | Study Chair |
| Tien Hoang, MD | University of Wisconsin, Madison | Study Chair |
| Valerie W. Rusch, MD, FACS | Memorial Sloan Kettering Cancer Center | Study Chair |
| James R. Jett, MD | Mayo Clinic | Study Chair |
| Scott A. Laurie, MD, FRCPC | Ottawa Regional Cancer Centre | Study Chair |
| Alan P. Lyss, MD | Missouri Baptist Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile Infirmary Medical Center | Mobile | Alabama | 36652-2144 | United States | ||
| Poudre Valley Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem | Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Chemotherapy + Radiotherapy |
|
Not provided
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| NETWORK |
| NCIC Clinical Trials Group | NETWORK |
| Cancer and Leukemia Group B | NETWORK |
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Not provided
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| docetaxel | Drug | During consolidation: 75 mg/m2 IV on Day 1, every 21 days for 3 cycles over 60 minutes |
|
| etoposide | Drug | During induction: 50 mg/m2, IV on Days 1 - 5 Days 29 - 33. In 250 ml of NS over 60 minutes. |
|
| conventional surgery | Procedure | If, based upon the evaluation in Section 7.4a, there is no evidence of progression (see Section 10.2d for definition), patients will proceed to the next appropriate step: Registration #2 and surgery followed by Registration #3 and additional chemotherapy (Sections 7.5 and 7.6). Response determinations (CR,PR, SD) will be required. If criteria for progressive measurable or nonmeasurable disease (see Section 10.0) are met, the patient will then be removed from protocol treatment and receive follow-up according to the schedule. Surgery will be performed 3 - 7 weeks after completion of chemoradiotherapy. |
|
| radiation therapy | Radiation | Radiotherapy is to begin within 24 hours following the start of chemotherapy. Day 1 of radiotherapy must be a Monday, Tuesday or Wednesday, but no later in the week to insure simultaneous therapy for the majority of each chemotherapy cycle. The total dose to the prescription point will be 4,500 cGy given in 25 fractions. The patient will be treated with one fraction per day with all fields treated per day. 180 cGy will be delivered to the isocenter. |
|
The duration from the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact.
| daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter. |
| Progression-Free Survival at 3 Years | Duration from date of enrollment to date of progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact. | At the completion of induction therapy, then again 4 weeks after the completion of consolidation therapy, then every 3 months for 2 years, then every 6 months until up to a maximum of 5 years after enrollment. |
| Response | Response was defined as achieving a confirmed or unconfirmed complete or partial response as determined by RECIST. Patients who dropped out due to any cause prior to getting their response assessment were counted as non-responders. A complete response (CR) was defined as disappearance of all disease. A partial response was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was defined as confirmed if two consecutive determinations were documented at least 4 weeks apart. | After completion of induction therapy. |
| Fort Collins |
| Colorado |
| 80524 |
| United States |
| Mayo Clinic - Jacksonville | Jacksonville | Florida | 32224 | United States |
| Rush-Copley Cancer Care Center | Aurora | Illinois | 60507 | United States |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | 60435 | United States |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| Regional Cancer Center at Memorial Medical Center | Springfield | Illinois | 62781-0001 | United States |
| Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | 61801 | United States |
| CCOP - Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Saint Anthony Memorial Health Centers | Michigan City | Indiana | 46360 | United States |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City | Iowa | 52242-1002 | United States |
| Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | 67042 | United States |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | United States |
| Southwest Medical Center | Liberal | Kansas | 67901 | United States |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | United States |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas, PA - Salina | Salina | Kansas | 67042 | United States |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67203 | United States |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | 67214 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | 67156 | United States |
| Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | 49221 | United States |
| Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | 48106-0995 | United States |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | 48106 | United States |
| Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | 49017 | United States |
| Mecosta County Medical Center | Big Rapids | Michigan | 49307 | United States |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | 48123-2500 | United States |
| Genesys Hurley Cancer Institute | Flint | Michigan | 48503 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| Metro Health Hospital | Grand Rapids | Michigan | 49506 | United States |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | 48236 | United States |
| Holland Community Hospital | Holland | Michigan | 49423 | United States |
| Foote Memorial Hospital | Jackson | Michigan | 49201 | United States |
| Borgess Medical Center | Kalamazoo | Michigan | 49001 | United States |
| West Michigan Cancer Center | Kalamazoo | Michigan | 49007-3731 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan | 48144 | United States |
| Sparrow Regional Cancer Center | Lansing | Michigan | 48912-1811 | United States |
| Community Cancer Center of Monroe | Monroe | Michigan | 48162 | United States |
| Mercy Memorial Hospital - Monroe | Monroe | Michigan | 48162 | United States |
| Hackley Hospital | Muskegon | Michigan | 49442 | United States |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | 48601 | United States |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield | Michigan | 48075 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| St. John Macomb Hospital | Warren | Michigan | 48093 | United States |
| Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | 55805-1983 | United States |
| CCOP - Duluth | Duluth | Minnesota | 55805 | United States |
| Miller - Dwan Medical Center | Duluth | Minnesota | 55805 | United States |
| Mayo Clinic Cancer Center | Rochester | Minnesota | 55905 | United States |
| Willmar Cancer Center at Rice Memorial Hospital | Willmar | Minnesota | 56201 | United States |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216 | United States |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | Columbia | Missouri | 65201 | United States |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia | Missouri | 65203 | United States |
| Missouri Baptist Cancer Center | St Louis | Missouri | 63131 | United States |
| Arch Medical Services, Incorporated at Center for Cancer Care and Research | St Louis | Missouri | 63141 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59101 | United States |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | United States |
| Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | United States |
| St. James Healthcare Cancer Care | Butte | Montana | 59701 | United States |
| Big Sky Oncology | Great Falls | Montana | 59405-5309 | United States |
| Great Falls Clinic - Main Facility | Great Falls | Montana | 59405 | United States |
| Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | 59405 | United States |
| Great Falls | Montana | 59405 | United States |
| St. Peter's Hospital | Helena | Montana | 59601 | United States |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | United States |
| Kalispell Medical Oncology at KRMC | Kalispell | Montana | 59901 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Community Medical Center | Missoula | Montana | 59801 | United States |
| Guardian Oncology and Center for Wellness | Missoula | Montana | 59804 | United States |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | United States |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59807 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Kinston Medical Specialists | Kinston | North Carolina | 28501 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | United States |
| Bismarck Cancer Center | Bismarck | North Dakota | 58501 | United States |
| Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | 58501 | United States |
| Mid Dakota Clinic, PC | Bismarck | North Dakota | 58501 | United States |
| St. Alexius Medical Center Cancer Center | Bismarck | North Dakota | 58502 | United States |
| Wood County Oncology Center | Bowling Green | Ohio | 43402 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210-1240 | United States |
| Fremont Memorial Hospital | Fremont | Ohio | 43420 | United States |
| St. Rita's Medical Center | Lima | Ohio | 45801 | United States |
| Lima Memorial Hospital | Lima | Ohio | 45804 | United States |
| Northwest Ohio Oncology Center | Maumee | Ohio | 43537 | United States |
| St. Luke's Hospital | Maumee | Ohio | 43537 | United States |
| St. Charles Mercy Hospital | Oregon | Ohio | 43616 | United States |
| Toledo Clinic - Oregon | Oregon | Ohio | 43616 | United States |
| Firelands Regional Medical Center | Sandusky | Ohio | 44870 | United States |
| North Coast Cancer Care, Incorporated | Sandusky | Ohio | 44870 | United States |
| Flower Hospital Cancer Center | Sylvania | Ohio | 43560 | United States |
| Mercy Hospital of Tiffin | Tiffin | Ohio | 44883 | United States |
| Toledo Hospital | Toledo | Ohio | 43606 | United States |
| St. Vincent Mercy Medical Center | Toledo | Ohio | 43608 | United States |
| Medical University of Ohio Cancer Center | Toledo | Ohio | 43614 | United States |
| CCOP - Toledo Community Hospital | Toledo | Ohio | 43617 | United States |
| Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | 43623 | United States |
| Fulton County Health Center | Wauseon | Ohio | 43567 | United States |
| Northwest Cancer Specialists at Rose Quarter Cancer Center | Portland | Oregon | 97227 | United States |
| AnMed Cancer Center | Anderson | South Carolina | 29621 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| MBCCOP - Meharry Medical College - Nashville | Nashville | Tennessee | 37208-3599 | United States |
| American Fork Hospital | American Fork | Utah | 84003 | United States |
| Sandra L. Maxwell Cancer Center | Cedar City | Utah | 84720 | United States |
| Logan Regional Hospital | Logan | Utah | 84321 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray | Utah | 84157 | United States |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| LDS Hospital | Salt Lake City | Utah | 84103 | United States |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | United States |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | United States |
| Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia | 22401 | United States |
| Auburn Regional Center for Cancer Care | Auburn | Washington | 98002 | United States |
| St. Joseph Cancer Center | Bellingham | Washington | 98225 | United States |
| Olympic Hematology and Oncology | Bremerton | Washington | 98310 | United States |
| Providence Centralia Hospital | Centralia | Washington | 98531-9027 | United States |
| St. Francis Hospital | Federal Way | Washington | 98003 | United States |
| Columbia Basin Hematology | Kennewick | Washington | 99336 | United States |
| Providence St. Peter Hospital Regional Cancer Center | Olympia | Washington | 98506-5166 | United States |
| Good Samaritan Cancer Center | Puyallup | Washington | 98372 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98104 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Minor and James Medical, PLLC | Seattle | Washington | 98104 | United States |
| Group Health Central Hospital | Seattle | Washington | 98112 | United States |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | 98122-4307 | United States |
| Polyclinic First Hill | Seattle | Washington | 98122 | United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | United States |
| Franciscan Cancer Center at St. Joseph Medical Center | Tacoma | Washington | 98405-3004 | United States |
| Allenmore Hospital | Tacoma | Washington | 98405 | United States |
| CCOP - Northwest | Tacoma | Washington | 98405 | United States |
| MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma | Washington | 98405 | United States |
| St. Clare Hospital | Tacoma | Washington | 98499 | United States |
| Northwest Cancer Specialists at Vancouver Cancer Center | Vancouver | Washington | 98684 | United States |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801-2028 | United States |
| Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg | West Virginia | 26102 | United States |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison | Wisconsin | 53792-6164 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Post Chemoradiation Assessment |
|
|
| Surgery |
|
|
| Consolidation Chemotherapy |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem | Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | 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 | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Adverse Events | Only adverse events that are possibly, probably or definitely related to study drug are reported. | Eligible patients who received the study intervention. | Posted | Number | Participants | Weekly for the first 13 weeks, then every 3 weeks for the next 6 weeks. |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Feasibility of Treating Patients With Stage IIB/IIIB Pancoast Tumors With a Regimen of Cisplatin and Etoposide Plus Concurrent Radiotherapy Followed by Surgical Resection Followed by Consolidation Therapy With Docetaxel. | Feasibility was assessed by estimating the percentage of participants who would be able to complete the entire treatment regimen. | Eligible patients who began the treatment regimen were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | After completion of 5 weeks of radiotherapy given concurrently with cisplatin+etoposide, surgery + 8 weeks of recovery time, and 6 weeks of consolidation therapy with docetaxel |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | The duration from the date of enrollment until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. | Eligible patients who began the treatment regimen were included in the analysis. | Posted | Median | 95% Confidence Interval | years | daily for 12 weeks then every 3 weeks for 12 weeks, then every 6 months thereafter. |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival at 3 Years | Duration from date of enrollment to date of progression (per RECIST), symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free were censored at the date of last contact. | Eligible patients who began the treatment regimen were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of patients | At the completion of induction therapy, then again 4 weeks after the completion of consolidation therapy, then every 3 months for 2 years, then every 6 months until up to a maximum of 5 years after enrollment. |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Response | Response was defined as achieving a confirmed or unconfirmed complete or partial response as determined by RECIST. Patients who dropped out due to any cause prior to getting their response assessment were counted as non-responders. A complete response (CR) was defined as disappearance of all disease. A partial response was defined as a >= 30% decrease in the sum of longest diameters of target lesions. A CR or PR was defined as confirmed if two consecutive determinations were documented at least 4 weeks apart. | Eligible patients who began the treatment regimen and who had measurable disease (per RECIST) at baseline were included in the analysis of response. | Posted | Number | 95% Confidence Interval | percentage of participants | After completion of induction therapy. |
|
|
Weekly for the first 12 weeks, then every 3 weeks for the next 6 weeks.
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 | Induction Cisplatin/Etoposide + XRT | 1 | 44 | 43 | 44 | |||
| EG001 | Surgery | 3 | 29 | 26 | 29 | |||
| EG002 | Consolidation Docetaxel | 0 | 22 | 21 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mucositis/stomatitis (clinical exam) - Esophagus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Inf (clin/microbio) w/Gr 3-4 neuts - Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC - Wound | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Adult respiratory distress syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| SVT and nodal arrhythmia - Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| SVT and nodal arrhythmia - Atrial flutter | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| SVT and nodal arrhythmia - SVT arrhythmia NOS | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastrointestinal-Other (Specify) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: head and neck | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever in absence of neutropenia, ANC lt1.0x10e9/L | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-Other (Specify) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Inf (clin/microbio) w/Gr 3-4 neuts - Wound | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Inf w/normal ANC or Gr 1-2 neutrophils - Wound | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: dermatitis associated w/radiation | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Chest wall | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration (dysgeusia) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Chylothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory-Other (Specify) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Voice changes/dysarthria | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hair loss/Alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lung Committee Statistician | SWOG Statistical Center | 206-667-4623 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D005047 | Etoposide |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |
Not provided
Not provided
| Physician Decision |
|
| Not eligible to continue to surgery |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Chylothorax |
|
| Dehydration |
|
| Diarrhea |
|
| Dyspnea (shortness of breath) |
|
| Esophagitis |
|
| Fatigue (asthenia, lethargy, malaise) |
|
| Febrile neutropenia |
|
| Fistula, pulmonary/upper respiratory - Bronchus |
|
| Fistula, pulmonary/upper respiratory - Lung |
|
| Glucose, serum-high (hyperglycemia) |
|
| Hemoglobin |
|
| Hemorrhage/bleeding w/surgery, intra- or post-op |
|
| Hypoxia |
|
| Inf (clin/microbio) w/Gr 3-4 neuts - Blood |
|
| Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus |
|
| Inf (clin/microbio) w/Gr 3-4 neuts - Lung |
|
| Inf (clin/microbio) w/Gr 3-4 neuts - Wound |
|
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung |
|
| Inf w/normal ANC or Gr 1-2 neutrophils - Meninges |
|
| Inf w/normal ANC or Gr 1-2 neutrophils - Wound |
|
| Infection with unknown ANC - Lung (pneumonia) |
|
| Infection with unknown ANC - Wound |
|
| Leak, cerebrospinal fluid (CSF) |
|
| Leukocytes (total WBC) |
|
| Lymphopenia |
|
| Metabolic/Laboratory-Other (Specify) |
|
| Mucositis/stomatitis (clinical exam) - Esophagus |
|
| Nausea |
|
| Neutrophils/granulocytes (ANC/AGC) |
|
| Pain - Chest wall |
|
| Pain - Extremity-limb |
|
| Pain-Other (Specify) |
|
| Platelets |
|
| Pulmonary/Upper Respiratory-Other (Specify) |
|
| SVT and nodal arrhythmia - Atrial fibrillation |
|
| Sodium, serum-low (hyponatremia) |
|
| Thrombosis/thrombus/embolism |
|
| Ventricular arrhythmia - Ventricular fibrillation |
|
| Vomiting |
|
| Weight loss |
|
|
|
|
|