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Proton Therapy With Chemotherapy for Stage III Non-Small Cell Lung Cancer (LU02) (LU02)

This study has been terminated.
(projected enrollment rate not feasible)
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00881712
First received: April 13, 2009
Last updated: September 13, 2016
Last verified: September 2016
Results First Received: May 28, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Small Cell Lung Cancer
Interventions: Radiation: PET positive nodal disease measuring 15 mm or greater
Radiation: PET positive nodal disease measuring less than 15 mm
Radiation: Patients considered resectable

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

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.

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.


Participant Flow:   Overall Study
    PET Positive Nodal Disease Measuring 15 mm or Greater   PET Positive Nodal Disease Measuring Less Than 15 mm   Patients Considered Resectable
STARTED   15   0 [1]   0 [1] 
COMPLETED   13   0   0 
NOT COMPLETED   2   0   0 
Death                1                0                0 
Withdrawal by Subject                1                0                0 
[1] This arm was non-randomized and no enrolled patients fit the inclusion criteria for this group.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

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.

Total Total of all reporting groups

Baseline Measures
   PET Positive Nodal Disease Measuring 15 mm or Greater   PET Positive Nodal Disease Measuring Less Than 15 mm   Patients Considered Resectable   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   0   0   13 
Age 
[Units: Participants]
       
<=18 years   0         0 
Between 18 and 65 years   7         7 
>=65 years   6         6 
Age 
[Units: Years]
Median (Full Range)
 62 
 (49 to 82) 
       62 
 (49 to 82) 
Gender 
[Units: Participants]
       
Female   4         4 
Male   9         9 
Region of Enrollment 
[Units: Participants]
       
United States   13         13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities   [ Time Frame: Six months after end of radiation therapy ]

2.  Secondary:   Percentage of Patients With Disease Control   [ Time Frame: Following treatment every 6 months for 2 years, then annually for 4 years. ]

3.  Secondary:   Percentage of Patients Alive at 5 Years   [ Time Frame: Five years following radiation treatment ]

4.  Secondary:   Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy   [ Time Frame: Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually ]

5.  Secondary:   Correlation of Functional CT-PET Imaging With Treatment Outcomes   [ Time Frame: 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Bradford Hoppe, M.D.
Organization: University of Florida Proton Therapy Institute
phone: 904-588-1000
e-mail: bhoppe@floridaproton.org


Publications:
Cancer Facts and Figures 2008 - American Cancer Society http://www.cancer.org/downloads/STT/2008CAFFfinalsecured.pdf
Delaney, Kooy editors: Proton and Charged particle Radiotherapy; LWW, 2008
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
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.
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).
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.
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.
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.
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.
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.


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00881712     History of Changes
Other Study ID Numbers: UFPTI 0802-LU02
Study First Received: April 13, 2009
Results First Received: May 28, 2015
Last Updated: September 13, 2016
Health Authority: United States: Institutional Review Board