Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    10487552 [PUBMED-IDS]
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00881712
Recruitment Status : Terminated (projected enrollment rate not feasible)
First Posted : April 15, 2009
Results First Posted : June 16, 2015
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PET Positive Nodal Disease Measuring 15 mm or Greater PET Positive Nodal Disease Measuring Less Than 15 mm Patients Considered Resectable
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 15 0 [1] 0 [1]
Completed 13 0 0
Not Completed 2 0 0
Reason Not Completed
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.
Arm/Group Title PET Positive Nodal Disease Measuring 15 mm or Greater PET Positive Nodal Disease Measuring Less Than 15 mm Patients Considered Resectable Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 13 0 0 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 0 participants 0 participants 13 participants
<=18 years
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  53.8%
7
  53.8%
>=65 years
6
  46.2%
6
  46.2%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants 0 participants 0 participants 13 participants
62
(49 to 82)
62
(49 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 0 participants 0 participants 13 participants
Female
4
  30.8%
4
  30.8%
Male
9
  69.2%
9
  69.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 0 participants 0 participants 13 participants
13 13
1.Primary Outcome
Title Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities
Hide Description [Not Specified]
Time Frame Six months after end of radiation therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PET Positive Nodal Disease Measuring 15 mm or Greater PET Positive Nodal Disease Measuring Less Than 15 mm Patients Considered Resectable
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 13 0 0
Measure Type: Number
Unit of Measure: participants
1
2.Secondary Outcome
Title Percentage of Patients With Disease Control
Hide Description 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.
Time Frame Following treatment every 6 months for 2 years, then annually for 4 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Thirteen enrolled patients that completed treatment
Arm/Group Title PET Positive Nodal Disease Measuring 15 mm or Greater PET Positive Nodal Disease Measuring Less Than 15 mm Patients Considered Resectable
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 13 0 0
Measure Type: Number
Unit of Measure: percentage of participants
69
3.Secondary Outcome
Title Percentage of Patients Alive at 5 Years
Hide Description [Not Specified]
Time Frame Five years following radiation treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Thirteen enrolled patients that completed treatment.
Arm/Group Title PET Positive Nodal Disease Measuring 15 mm or Greater PET Positive Nodal Disease Measuring Less Than 15 mm Patients Considered Resectable
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 13 0 0
Measure Type: Number
Unit of Measure: percentage of patients
69
4.Secondary Outcome
Title Feasibility, Safety and Efficacy of Delivering Proton Radiotherapy With Concomitant Chemotherapy
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
This data was not collected as study was terminated early.
Arm/Group Title PET Positive Nodal Disease Measuring 15 mm or Greater PET Positive Nodal Disease Measuring Less Than 15 mm Patients Considered Resectable
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Correlation of Functional CT-PET Imaging With Treatment Outcomes
Hide Description [Not Specified]
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
Hide Outcome Measure Data
Hide Analysis Population Description
This data was not collected as study was terminated early.
Arm/Group Title PET Positive Nodal Disease Measuring 15 mm or Greater PET Positive Nodal Disease Measuring Less Than 15 mm Patients Considered Resectable
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PET Positive Nodal Disease Measuring 15 mm or Greater PET Positive Nodal Disease Measuring Less Than 15 mm Patients Considered Resectable
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
PET Positive Nodal Disease Measuring 15 mm or Greater PET Positive Nodal Disease Measuring Less Than 15 mm Patients Considered Resectable
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PET Positive Nodal Disease Measuring 15 mm or Greater PET Positive Nodal Disease Measuring Less Than 15 mm Patients Considered Resectable
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      0/0      0/0    
Gastrointestinal disorders       
Nausea  1 [1]  1/13 (7.69%)  1 0/0  0 0/0  0
General disorders       
Pain  1 [1]  1/13 (7.69%)  1 0/0  0 0/0  0
Metabolism and nutrition disorders       
Weight loss  1 [1]  1/13 (7.69%)  1 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders       
Pneumonitis  1 [1]  1/13 (7.69%)  1 0/0  0 0/0  0
Hypoxia  1 [1]  1/13 (7.69%)  1 0/0  0 0/0  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Grade 3
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PET Positive Nodal Disease Measuring 15 mm or Greater PET Positive Nodal Disease Measuring Less Than 15 mm Patients Considered Resectable
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/13 (100.00%)      0/0      0/0    
Blood and lymphatic system disorders       
White blood cell count  1  4/13 (30.77%)  4 0/0  0 0/0  0
Platelet count  1  1/13 (7.69%)  1 0/0  0 0/0  0
Gastrointestinal disorders       
Esophageal stenosis  1  1/13 (7.69%)  1 0/0  0 0/0  0
General disorders       
Pain  1  7/13 (53.85%)  7 0/0  0 0/0  0
Radiation dermatitis  1  4/13 (30.77%)  4 0/0  0 0/0  0
Fatigue  1  2/13 (15.38%)  2 0/0  0 0/0  0
Weight loss  1  2/13 (15.38%)  2 0/0  0 0/0  0
Alopecia  1  1/13 (7.69%)  1 0/0  0 0/0  0
Respiratory, thoracic and mediastinal disorders       
Dyspnea  1  5/13 (38.46%)  5 0/0  0 0/0  0
Cough  1  4/13 (30.77%)  4 0/0  0 0/0  0
Bronchial stricture  1  2/13 (15.38%)  2 0/0  0 0/0  0
Hypoxia  1  2/13 (15.38%)  2 0/0  0 0/0  0
Fibrosis  1  2/13 (15.38%)  2 0/0  0 0/0  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: 904-588-1800
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
First Submitted: April 13, 2009
First Posted: April 15, 2009
Results First Submitted: May 28, 2015
Results First Posted: June 16, 2015
Last Update Posted: September 11, 2017