Trial Outcomes & Findings for Proton Radiotherapy for Patients With Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00495040)
NCT ID: NCT00495040
Last Updated: 2019-01-14
Results Overview
Chest CT with contrast (if possible) was used for evaluation of Local control. If is suspicious for recurrence by CT image, PET or PET/CT scan is required and biopsy is recommended to confirm the recurrence. Continuing CT or PET images follow up for un-confirmed recurrent disease. Timing of recurrence: at the time of first image (PET and/or CT) showing abnormalities. PET will use for progression free survival (PFS). Participants were followed up at 6 weeks after the completion of RT, every 3 months (±1 month) for 2 years, every 6 months (±1 month) for 3 years, and then annually. The Overall survival: time of registration to the last follow-up (f/u), or lost to f/u, or death. The PFS: time of registration to any local-regional recurrence or distant metastasis. Free local recurrence rate: time of registration to local recurrence. Free regional recurrence rate: time of registration to regional recurrence. Free distant metastasis rate: time of registration to distant metastasis.
COMPLETED
PHASE2
38 participants
The Overall survival (OS): time of registration to the last follow-up (f/u), or lost to f/u, or death up to 5 years. The progression free survival (PFS): time of registration to any local-regional recurrence or distant metastasis up to 5 years.
2019-01-14
Participant Flow
(1)Inoperable NSCLC;(2)T1N0M0 (stage IA) that was centrally or superiorly located ≤ 2 cm in all directions of any critical mediastinal structure; T2N0M0 in any location (stage IB, tumor size\>3 cm, with no upper size limit), or selected T3N0M0 (stage II,chest wall, mediastinal pleura, or parietal pericardium involvement) in any location (3)ECOG≤2
Participant milestones
| Measure |
Dose-escalated Proton Therapy for Early-stage NSCLC
35 patients were treated with 87.5 Gy at 2.5 Gy/fraction of proton therapy, with fraction given once a day, 5 days per week. The biological effective dose was 109.4 Gy using α/β of 10
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|---|---|
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Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
35
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|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Dose-escalated Proton Therapy for Early-stage NSCLC
35 patients were treated with 87.5 Gy at 2.5 Gy/fraction of proton therapy, with fraction given once a day, 5 days per week. The biological effective dose was 109.4 Gy using α/β of 10
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|---|---|
|
Overall Study
Withdrawal by Subject
|
3
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Baseline Characteristics
There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
Baseline characteristics by cohort
| Measure |
Dose-escalated Proton Therapy for Early-stage Non-small Cell l
n=35 Participants
35 patients were treated with 87.5 Gy at 2.5 Gy/fraction of proton therapy, with fraction given once a day, 5 days per week. The biological effective dose was 109.4 Gy using α/β of 10
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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33 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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35 Participants
n=5 Participants
|
|
Age
|
73 years
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
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|
Karnofsky Performance Status (KPS) Score
|
80 units on a scale (%)
n=5 Participants • The Karnofsky Performance Score (KPS) ranking runs from 100 to 0, where 100 is "perfect" Normal health and 0 is death. Practitioners occasionally assign performance scores in between standard intervals of 10. The KPS was to allow physicians to evaluate a patient's survival. The higher KPS scores, the better treatment outcome.
|
|
Gross Tumor Volume (GTV)
|
42.9 cubic centimeters
n=5 Participants • In this study, Gross tumor volume is all known gross disease as demonstrated on end ventilation data set (30% phase as determined by Varian RPM or equivalent respiratory monitoring system) of the planning 4DCT using a lung window, and modified as deemed necessary based on PET/CT, diagnostic CT and other clinical studies.
|
|
iCTV (internal Clinical Target Volume)
|
123 cubic centimeters
n=5 Participants • iCTV (internal Clinical Target Volume): Volume encompassing the Clinical Target Volume (CTV) and Internal Margin (IM). (iCTV = CTV + IM). In this study, the iCTV is envelope of motion of the CTV estimated by an 8-mm isotropic expansion of the iGTV to encompase microextensions of the tumor (iCTV = iGTV+8mm);
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Pre-Treatment Pulmonary Function - FEV1
|
48 percentage of predicted (%)
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
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|
Pre-Treatment Pulmonary Function - DLCO
|
49 percentage of predicted (%)
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
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|
Smoking History
Yes
|
31 Participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
|
|
Smoking History
No
|
4 Participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
|
|
Chronic Pulmonary Disease
COPD
|
16 Participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
|
|
Chronic Pulmonary Disease
Emphysema
|
3 Participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
|
|
Chronic Pulmonary Disease
Pulmonary Fibrosis
|
1 Participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
|
|
Chronic Pulmonary Disease
Normal
|
15 Participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
|
|
Tumor Histological Type
Squamous cell carcinoma
|
17 Participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
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Tumor Histological Type
Adenocarcinoma
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11 Participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
|
|
Tumor Histological Type
Squamous cell carcinoma + adenocarcinoma
|
1 Participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
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|
Tumor Histological Type
Neuroendocrine carcinoma
|
1 Participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
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|
Tumor Histological Type
Non-small cell carcinoma
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5 Participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
|
|
Number of Participants with Tumor Location
Central or Superior
|
25 Participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
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|
Number of Participants with Tumor Location
Peripheral
|
10 Participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
|
|
Number of Participants with Tumor size
≤3 cm
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13 participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
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|
Number of Participants with Tumor size
>3 cm ≤ 5 cm
|
16 participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
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|
Number of Participants with Tumor size
>5 cm
|
6 participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
|
|
Number of Participants with Primary Tumor (T) Stage
T1:Tumor ≤3 cm in greatest dimension
|
12 participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
|
|
Number of Participants with Primary Tumor (T) Stage
T2:tumor>3 cm; involve: main bronchus, the viscera
|
20 participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
|
|
Number of Participants with Primary Tumor (T) Stage
T3
|
3 participants
n=5 Participants • There were 35 out of 38 patients treated under the protocol and evaluable for data analysis.
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|
Number of Participants with Clinical Stage
IA
|
12 participants
n=5 Participants
|
|
Number of Participants with Clinical Stage
IB
|
16 participants
n=5 Participants
|
|
Number of Participants with Clinical Stage
IIA
|
4 participants
n=5 Participants
|
|
Number of Participants with Clinical Stage
IIB
|
3 participants
n=5 Participants
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PRIMARY outcome
Timeframe: The Overall survival (OS): time of registration to the last follow-up (f/u), or lost to f/u, or death up to 5 years. The progression free survival (PFS): time of registration to any local-regional recurrence or distant metastasis up to 5 years.Population: Kaplan-Meier curves used for overall survival, progression-free survival, local recurrence-free survival, regional recurrence-free survival, and distant metastasis-free survival. Differences between pairs of Kaplan-Meier curves were using the log-rank test. The Fisher's exact test was used to compare local, regional, and distant recurrence rates.
Chest CT with contrast (if possible) was used for evaluation of Local control. If is suspicious for recurrence by CT image, PET or PET/CT scan is required and biopsy is recommended to confirm the recurrence. Continuing CT or PET images follow up for un-confirmed recurrent disease. Timing of recurrence: at the time of first image (PET and/or CT) showing abnormalities. PET will use for progression free survival (PFS). Participants were followed up at 6 weeks after the completion of RT, every 3 months (±1 month) for 2 years, every 6 months (±1 month) for 3 years, and then annually. The Overall survival: time of registration to the last follow-up (f/u), or lost to f/u, or death. The PFS: time of registration to any local-regional recurrence or distant metastasis. Free local recurrence rate: time of registration to local recurrence. Free regional recurrence rate: time of registration to regional recurrence. Free distant metastasis rate: time of registration to distant metastasis.
Outcome measures
| Measure |
Dose-escalated Proton Therapy for Early-stage Non-small Cell l
n=35 Participants
35 patients were treated with 87.5 Gy at 2.5 Gy/fraction of proton therapy, with fraction given once a day, 5 days per week. The biological effective dose was 109.4 Gy using α/β of 10
|
|---|---|
|
Overall Survival and Progression Free Survival
Overall Survival rate : 1 year
|
85.70 percentage of participants (%)
|
|
Overall Survival and Progression Free Survival
Overall Survival rate : 2 year
|
60 percentage of participants (%)
|
|
Overall Survival and Progression Free Survival
Overall Survival rate : 3 year
|
42.90 percentage of participants (%)
|
|
Overall Survival and Progression Free Survival
Overall Survival rate : 5 year
|
28.10 percentage of participants (%)
|
|
Overall Survival and Progression Free Survival
Progression Free Survival rate : 1 year
|
80 percentage of participants (%)
|
|
Overall Survival and Progression Free Survival
Progression Free Survival rate : 2 year
|
64.40 percentage of participants (%)
|
|
Overall Survival and Progression Free Survival
Progression Free Survival rate : 3 year
|
53.60 percentage of participants (%)
|
|
Overall Survival and Progression Free Survival
Progression Free Survival rate : 5 year
|
53.60 percentage of participants (%)
|
|
Overall Survival and Progression Free Survival
free local recurrence rate 5-year
|
85 percentage of participants (%)
|
|
Overall Survival and Progression Free Survival
free from regional recurrence rate: 5-year
|
89.20 percentage of participants (%)
|
|
Overall Survival and Progression Free Survival
free from distant metastasis rate: 5-year
|
56 percentage of participants (%)
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Adverse Events
Dose-escalated Proton Therapy for Early-stage Non-small Cell l
Serious adverse events
| Measure |
Dose-escalated Proton Therapy for Early-stage Non-small Cell l
n=35 participants at risk
35 patients were treated with 87.5 Gy at 2.5 Gy/fraction of proton therapy, with fraction given once a day, 5 days per week. The biological effective dose was 109.4 Gy using α/β of 10
|
|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
2.9%
1/35 • From the time of registration to the time of the adverse event start date, up to 5 years.
Grade \> 3 acute and chronic toxicities by Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE 3.0) will be analyzed.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.9%
1/35 • From the time of registration to the time of the adverse event start date, up to 5 years.
Grade \> 3 acute and chronic toxicities by Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE 3.0) will be analyzed.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/35 • From the time of registration to the time of the adverse event start date, up to 5 years.
Grade \> 3 acute and chronic toxicities by Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE 3.0) will be analyzed.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/35 • From the time of registration to the time of the adverse event start date, up to 5 years.
Grade \> 3 acute and chronic toxicities by Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE 3.0) will be analyzed.
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
0.00%
0/35 • From the time of registration to the time of the adverse event start date, up to 5 years.
Grade \> 3 acute and chronic toxicities by Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE 3.0) will be analyzed.
|
|
General disorders
Chest wall pain
|
0.00%
0/35 • From the time of registration to the time of the adverse event start date, up to 5 years.
Grade \> 3 acute and chronic toxicities by Common Terminology Criteria for Adverse Events, version 3.0 (CTCAE 3.0) will be analyzed.
|
Other adverse events
Adverse event data not reported
Additional Information
Chang,Joe Y.,M.D. / Radiation Oncology
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place