Trial Outcomes & Findings for Proton Therapy With Chemotherapy for Stage III Non-Small Cell Lung Cancer (LU02) (NCT NCT00881712)

NCT ID: NCT00881712

Last Updated: 2017-09-11

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

Six months after end of radiation therapy

Results posted on

2017-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	15	0	0
Overall Study COMPLETED	13	0	0
Overall Study NOT COMPLETED	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	1	0	0
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PET Positive Nodal Disease Measuring 15 mm or Greater n=13 Participants 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 n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	—	—	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=99 Participants	—	—	7 Participants n=7 Participants
Age, Categorical >=65 years	6 Participants n=99 Participants	—	—	6 Participants n=7 Participants
Age, Continuous	62 Years n=99 Participants	—	—	62 Years n=7 Participants
Sex: Female, Male Female	4 Participants n=99 Participants	—	—	4 Participants n=7 Participants
Sex: Female, Male Male	9 Participants n=99 Participants	—	—	9 Participants n=7 Participants
Region of Enrollment United States	13 participants n=99 Participants	—	—	13 participants n=7 Participants

PRIMARY outcome

Timeframe: Six months after end of radiation therapy

Outcome measures

Outcome measures
Measure	PET Positive Nodal Disease Measuring 15 mm or Greater n=13 Participants 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.
Grade 3 or Higher Rate of Non-hematologic, Acute Treatment-related Toxicities	1 participants	—	—

SECONDARY outcome

Timeframe: Following treatment every 6 months for 2 years, then annually for 4 years.

Population: Thirteen enrolled patients that completed treatment

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.

Outcome measures

Outcome measures
Measure	PET Positive Nodal Disease Measuring 15 mm or Greater n=13 Participants 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.
Percentage of Patients With Disease Control	69 percentage of participants	—	—

SECONDARY outcome

Timeframe: Five years following radiation treatment

Population: Thirteen enrolled patients that completed treatment.

Outcome measures

Outcome measures
Measure	PET Positive Nodal Disease Measuring 15 mm or Greater n=13 Participants 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.
Percentage of Patients Alive at 5 Years	69 percentage of patients	—	—

SECONDARY outcome

Timeframe: Weekly during treatment, then every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, then annually

Population: This data was not collected as study was terminated early.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Population: This data was not collected as study was terminated early.

Outcome measures

Outcome data not reported

Adverse Events

PET Positive Nodal Disease Measuring 15 mm or Greater

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

PET Positive Nodal Disease Measuring Less Than 15 mm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients Considered Resectable

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PET Positive Nodal Disease Measuring 15 mm or Greater n=13 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.7% 1/13 • Number of events 1 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.7% 1/13 • Number of events 1 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
General disorders Pain	7.7% 1/13 • Number of events 1 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
Gastrointestinal disorders Nausea	7.7% 1/13 • Number of events 1 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
Metabolism and nutrition disorders Weight loss	7.7% 1/13 • Number of events 1 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.

Other adverse events

Other adverse events
Measure	PET Positive Nodal Disease Measuring 15 mm or Greater n=13 participants at risk 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.
General disorders Pain	53.8% 7/13 • Number of events 7 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
Respiratory, thoracic and mediastinal disorders Dyspnea	38.5% 5/13 • Number of events 5 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
Respiratory, thoracic and mediastinal disorders Cough	30.8% 4/13 • Number of events 4 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
General disorders Radiation dermatitis	30.8% 4/13 • Number of events 4 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
Blood and lymphatic system disorders White blood cell count	30.8% 4/13 • Number of events 4 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
General disorders Fatigue	15.4% 2/13 • Number of events 2 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
Respiratory, thoracic and mediastinal disorders Bronchial stricture	15.4% 2/13 • Number of events 2 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
Respiratory, thoracic and mediastinal disorders Hypoxia	15.4% 2/13 • Number of events 2 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
General disorders Weight loss	15.4% 2/13 • Number of events 2 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
Respiratory, thoracic and mediastinal disorders Fibrosis	15.4% 2/13 • Number of events 2 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
General disorders Alopecia	7.7% 1/13 • Number of events 1 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
Gastrointestinal disorders Esophageal stenosis	7.7% 1/13 • Number of events 1 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.
Blood and lymphatic system disorders Platelet count	7.7% 1/13 • Number of events 1 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.	— 0/0 • Cumulative adverse events assessed across all available post-treatment follow-up for each patient.

Additional Information

Bradford Hoppe, M.D.

University of Florida Proton Therapy Institute

Phone: 904-588-1800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place