Not provided
Not provided
Not provided
Not provided
projected enrollment rate not feasible
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to find out what effects, good and/or bad, proton radiation at a higher tumor dose (and lower normal surrounding lung dose) combined with standard chemotherapy has on lung cancer. The dose you receive to the tumor will be higher than the standard dose. This may be able to increase the control of the tumor. Due to the accuracy of radiation given with protons, the dose to the normal lung tissue that surrounds the tumor will be lower than standard. This may be able to reduce the frequency and severity of the usual radiation side effects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET positive nodal disease measuring 15 mm or greater | Experimental | Proton radiation with concomitant chemotherapy |
|
| PET positive nodal disease measuring less than 15 mm | Experimental | Proton radiation |
|
| Patients considered resectable | Experimental | Proton radiation plus surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PET positive nodal disease measuring 15 mm or greater | Radiation | Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities | Six months after end of radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Disease Control | Disease control rate is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). As per RECIST version 1.1, Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."), as accurate. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bradford S Hoppe, MD, MPH | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Proton Therapy Institute | Jacksonville | Florida | 32206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Cancer Facts and Figures 2008 - American Cancer Society http://www.cancer.org/downloads/STT/2008CAFFfinalsecured.pdf | ||
| Background | Delaney, Kooy editors: Proton and Charged particle Radiotherapy; LWW, 2008 | ||
| 16682145 | Background | Chang JY, Zhang X, Wang X, Kang Y, Riley B, Bilton S, Mohan R, Komaki R, Cox JD. Significant reduction of normal tissue dose by proton radiotherapy compared with three-dimensional conformal or intensity-modulated radiation therapy in Stage I or Stage III non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1087-96. doi: 10.1016/j.ijrobp.2006.01.052. Epub 2006 May 6. | |
| 18166995 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PET Positive Nodal Disease Measuring 15 mm or Greater | Proton radiation with concomitant chemotherapy PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy. |
| FG001 | PET Positive Nodal Disease Measuring Less Than 15 mm | Proton radiation PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy. |
| FG002 | Patients Considered Resectable | Proton radiation plus surgery Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PET Positive Nodal Disease Measuring 15 mm or Greater | Proton radiation with concomitant chemotherapy PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy. |
| BG001 |
| 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 |
| 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 | Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities | Posted | Number | participants | Six months after end of radiation therapy |
|
Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
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 | PET Positive Nodal Disease Measuring 15 mm or Greater | Proton radiation with concomitant chemotherapy PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bradford Hoppe, M.D. | University of Florida Proton Therapy Institute | 904-588-1800 | bhoppe@floridaproton.org |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D061766 | Proton Therapy |
| ID | Term |
|---|---|
| D063193 | Heavy Ion Radiotherapy |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| PET positive nodal disease measuring less than 15 mm | Radiation | Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy. |
|
|
| Patients considered resectable | Radiation | Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed. |
|
|
| Following treatment every 6 months for 2 years, then annually for 4 years. |
| Percentage of Patients Alive at 5 Years | Five years following radiation treatment |
| Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy | Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually |
| Correlation of Functional CT-PET Imaging With Treatment Outcomes | Prestudy, before surgery (if applicable) between days 18-22 if needed, then during follow-up every 6 months for 2 years, then annually for 4 years |
| Background |
| Auberger T, Seydl K, Futschek T, Sztankay A, Sweeney RA, Lukas P. Photons or protons: precision radiotherapy of lung cancer. Strahlenther Onkol. 2007 Dec;183 Spec No 2:3-6. doi: 10.1007/s00066-007-2002-9. No abstract available. |
| Background | Nichols RC, Henderson RH, Huh SN, Flampouri S, Cury JD, Pham DC, D'Agostino HJ, Louis D, Li Z, Mendenhall NP. Proton Radiotherapy Offers Reduced Bone Marrow and Normal Lung Exposure for Patients Receiving Dose Escalated Radiotherapy with Concomitant Chemotherapy for Regionally Advanced Non-Small Cell Lung Cancer. Presented at the LALCa 2008 - 3rd Latin American Conference on Lung Cancer - Tercera Conferencia Latinoamericana sobre Cancer Pulmonar - Vina del Mar, Chile - October 9 and 10, 2008 |
| 10487552 | Background | Graham MV, Purdy JA, Emami B, Harms W, Bosch W, Lockett MA, Perez CA. Clinical dose-volume histogram analysis for pneumonitis after 3D treatment for non-small cell lung cancer (NSCLC). Int J Radiat Oncol Biol Phys. 1999 Sep 1;45(2):323-9. doi: 10.1016/s0360-3016(99)00183-2. |
| 14630268 | Background | Lee HK, Vaporciyan AA, Cox JD, Tucker SL, Putnam JB Jr, Ajani JA, Liao Z, Swisher SG, Roth JA, Smythe WR, Walsh GL, Mohan R, Liu HH, Mooring D, Komaki R. Postoperative pulmonary complications after preoperative chemoradiation for esophageal carcinoma: correlation with pulmonary dose-volume histogram parameters. Int J Radiat Oncol Biol Phys. 2003 Dec 1;57(5):1317-22. doi: 10.1016/s0360-3016(03)01373-7. |
| Background | Komaki R, Sejpal S, Wei X, et al. Reduction of Bone Marrow Suppression for Patients with Stage III NSCLC Treated by Proton and Chemotherapy Compared with IMRT and Chemotherapy. Proceedings of the PTCOG 47, May 19-24, 2008. |
| Background | Curran W, Scott C, Langer C, et al. Long term benefit is observed in a phase III comparison of sequential vs. concurrent chemo-radiation for patients with unresectable NSCLC: RTOG 9410. Proc Am Soc Clin Oncol 2003;61(abstr). |
| 10561343 | Background | Furuse K, Fukuoka M, Kawahara M, Nishikawa H, Takada Y, Kudoh S, Katagami N, Ariyoshi Y. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 1999 Sep;17(9):2692-9. doi: 10.1200/JCO.1999.17.9.2692. |
| 11395236 | Background | Rosenzweig KE, Sim SE, Mychalczak B, Braban LE, Schindelheim R, Leibel SA. Elective nodal irradiation in the treatment of non-small-cell lung cancer with three-dimensional conformal radiation therapy. Int J Radiat Oncol Biol Phys. 2001 Jul 1;50(3):681-5. doi: 10.1016/s0360-3016(01)01482-1. |
| Background | Martel MK, et al. Incidental doses to clinically negative nodes from conformal treatment fields for non-small cell lung cancer. Int J Rad Oncol Biol Phys. 45(3 (supplement)): 244, 1999. |
| Background | Nichols RC, Huh SN, Hoppe BS, Henderson RH, Li Z, Mendenhall NP. Protons Safely Allow Coverage of High Risk Nodes for Patients with Regionally Advanced NSCLC, University of Florida Proton Therapy Institute. Submitted for consideration. American Radium Society, 2009. |
| 12243807 | Background | Rosenman JG, Halle JS, Socinski MA, Deschesne K, Moore DT, Johnson H, Fraser R, Morris DE. High-dose conformal radiotherapy for treatment of stage IIIA/IIIB non-small-cell lung cancer: technical issues and results of a phase I/II trial. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):348-56. doi: 10.1016/s0360-3016(02)02958-9. |
| 3032394 | Background | Perez CA, Pajak TF, Rubin P, Simpson JR, Mohiuddin M, Brady LW, Perez-Tamayo R, Rotman M. Long-term observations of the patterns of failure in patients with unresectable non-oat cell carcinoma of the lung treated with definitive radiotherapy. Report by the Radiation Therapy Oncology Group. Cancer. 1987 Jun 1;59(11):1874-81. doi: 10.1002/1097-0142(19870601)59:113.0.co;2-z. |
| 4630323 | Background | Fletcher GH. Clinical dose-response curves of human malignant epithelial tumours. Br J Radiol. 1973 Jan;46(541):1-12. doi: 10.1259/0007-1285-46-541-1. No abstract available. |
| Background | Albain KS, Swann RS, Rusch VR, et al. Phase III study of concurrent chemotherapy and radiotherapy (CT/RT) vs. CT/RT followed by surgical resection for stage IIIA (pN2) non-small cell lung cancer (NSCLC): Outcomes update of North American Intergroup 0139 (RTOG 9309). Proc Am Soc Clin Oncol, abstract 7014, 2005. |
| 11208837 | Background | Lau D, Leigh B, Gandara D, Edelman M, Morgan R, Israel V, Lara P, Wilder R, Ryu J, Doroshow J. Twice-weekly paclitaxel and weekly carboplatin with concurrent thoracic radiation followed by carboplatin/paclitaxel consolidation for stage III non-small-cell lung cancer: a California Cancer Consortium phase II trial. J Clin Oncol. 2001 Jan 15;19(2):442-7. doi: 10.1200/JCO.2001.19.2.442. |
| 9779707 | Background | Choy H, Akerley W, Safran H, Graziano S, Chung C, Williams T, Cole B, Kennedy T. Multiinstitutional phase II trial of paclitaxel, carboplatin, and concurrent radiation therapy for locally advanced non-small-cell lung cancer. J Clin Oncol. 1998 Oct;16(10):3316-22. doi: 10.1200/JCO.1998.16.10.3316. |
| Background | Vokes E, Herndon J, Turrisi A. Induction chemotherapy followed by concomitant chemoradiotherapy (CT/XRT) versus CT/XRT alone for regionally advanced unresectable non-small cell lung cancer (NSCLC): Initial analysis of a randomized phase III trial. Pro Amer Soc Clin Oncol. 23(616A), 2004. |
| Background | Bradley J, et al. Phase I results of RTOG 0117; A phase I/II dose intensification study using 3DCRTand concurrent chemotherapy for patients with inoperable non-small cell lung cancer. Pro Amer Soc Clin Oncol. 24: p. 7063A, 2005. |
| Background | Blackstock A. Cancer and Leukemia Group B: Induction plus concurrent chemotherapy with high dose (74 Gy) 3 dimensional (3-D) thoracic radiotherapy in stage III non-small cell lung cancer. Preliminary report of CALGB 30105. Pro Amer Soc Clin Oncol. 24(1): 7042, 2006. |
| 9792048 | Background | Roth JA, Atkinson EN, Fossella F, Komaki R, Bernadette Ryan M, Putnam JB Jr, Lee JS, Dhingra H, De Caro L, Chasen M, Hong WK. Long-term follow-up of patients enrolled in a randomized trial comparing perioperative chemotherapy and surgery with surgery alone in resectable stage IIIA non-small-cell lung cancer. Lung Cancer. 1998 Jul;21(1):1-6. doi: 10.1016/s0169-5002(98)00046-4. |
| 16087941 | Background | Belani CP, Choy H, Bonomi P, Scott C, Travis P, Haluschak J, Curran WJ Jr. Combined chemoradiotherapy regimens of paclitaxel and carboplatin for locally advanced non-small-cell lung cancer: a randomized phase II locally advanced multi-modality protocol. J Clin Oncol. 2005 Sep 1;23(25):5883-91. doi: 10.1200/JCO.2005.55.405. Epub 2005 Aug 8. |
| 18421118 | Background | Chvetsov AV, Palta JJ, Nagata Y. Time-dependent cell disintegration kinetics in lung tumors after irradiation. Phys Med Biol. 2008 May 7;53(9):2413-23. doi: 10.1088/0031-9155/53/9/013. Epub 2008 Apr 17. |
| 16111586 | Background | Chapet O, Kong FM, Quint LE, Chang AC, Ten Haken RK, Eisbruch A, Hayman JA. CT-based definition of thoracic lymph node stations: an atlas from the University of Michigan. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):170-8. doi: 10.1016/j.ijrobp.2004.12.060. |
| PET Positive Nodal Disease Measuring Less Than 15 mm |
Proton radiation PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy. |
| BG002 | Patients Considered Resectable | Proton radiation plus surgery Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Patients Considered Resectable | Proton radiation plus surgery Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed. |
|
|
| Secondary | Percentage of Patients With Disease Control | Disease control rate is defined as Complete Response (CR) + Partial Response (PR) + Stable Disease (SD). As per RECIST version 1.1, Complete Response (CR): Disappearance of all target lesions, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."), as accurate. | Thirteen enrolled patients that completed treatment | Posted | Number | percentage of participants | Following treatment every 6 months for 2 years, then annually for 4 years. |
|
|
|
| Secondary | Percentage of Patients Alive at 5 Years | Thirteen enrolled patients that completed treatment. | Posted | Number | percentage of patients | Five years following radiation treatment |
|
|
|
| Secondary | Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy | This data was not collected as study was terminated early. | Posted | Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually |
|
|
| Secondary | Correlation of Functional CT-PET Imaging With Treatment Outcomes | This data was not collected as study was terminated early. | Posted | Prestudy, before surgery (if applicable) between days 18-22 if needed, then during follow-up every 6 months for 2 years, then annually for 4 years |
|
|
| 2 |
| 13 |
| 13 |
| 13 |
| EG001 | PET Positive Nodal Disease Measuring Less Than 15 mm | Proton radiation PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy. | 0 | 0 | 0 | 0 |
| EG002 | Patients Considered Resectable | Proton radiation plus surgery Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed. | 0 | 0 | 0 | 0 |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 |
|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 |
|
| Weight loss | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Grade 3 |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Radiation dermatitis | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| White blood cell count | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bronchial stricture | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fibrosis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Esophageal stenosis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelet count | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |