Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U10CA076001 | U.S. NIH Grant/Contract | View source | |
| CALGB-39904 | |||
| CDR0000068409 | Registry Identifier | NCI Physician Data Query |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks.
Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity.
Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy | Experimental | Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks. Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity. Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| accelerated conformational radiotherapy | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Up to 5 years | |
| Failure-free survival | Up to 5 years |
Not provided
Not provided
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC)
Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows)
No metastatic disease or hilar or mediastinal lymphadenopathy
Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan
Poor surgical risk, as defined by 1 of the following:
High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy
Pulmonary dysfunction indicated by one or more of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Other:
Chemotherapy:
Radiotherapy:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Bogart, MD | State University of New York - Upstate Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19933904 | Result | Bogart JA, Hodgson L, Seagren SL, Blackstock AW, Wang X, Lenox R, Turrisi AT 3rd, Reilly J, Gajra A, Vokes EE, Green MR. Phase I study of accelerated conformal radiotherapy for stage I non-small-cell lung cancer in patients with pulmonary dysfunction: CALGB 39904. J Clin Oncol. 2010 Jan 10;28(2):202-6. doi: 10.1200/JCO.2009.25.0753. Epub 2009 Nov 23. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Memorial Cancer Institute at Memorial Regional Hospital |
| Hollywood |
| Florida |
| 33021 |
| United States |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter | Florida | 33458 | United States |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637-1470 | United States |
| Fairview University Medical Center - University Campus | Minneapolis | Minnesota | 55455 | United States |
| Saint Luke's Hospital | Chesterfield | Missouri | 63017 | United States |
| Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | Grand Island | Nebraska | 68803 | United States |
| Great Plains Regional Medical Center | North Platte | Nebraska | 69103 | United States |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Veterans Affairs Medical Center - Buffalo | Buffalo | New York | 14215 | United States |
| Oswego Hospital | Oswego | New York | 13126 | United States |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York | 13057 | United States |
| St. Joseph's Hospital Health Center - Syracuse | Syracuse | New York | 13203 | United States |
| SUNY Upstate Medical University Hospital | Syracuse | New York | 13210 | United States |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Comprehensive Cancer Center at Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus | Ohio | 43210 | United States |
| Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | 15224-1791 | United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| 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 |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided