Trial Outcomes & Findings for Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer (NCT NCT00087438)

Last Updated: 2019-01-16

Results Overview

Local control is defined as absence of local failure, which is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Local control time is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local failure (censored). Rates are estimated using the Kaplan-Meier method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

From the start of treatment to 2 years

Results posted on

2019-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	Stereotactic Body Radiation Therapy (SBRT) 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
Overall Study STARTED	59
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Stereotactic Body Radiation Therapy (SBRT) 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
Overall Study Ineligible / No protocol treatment	4

Baseline Characteristics

Stereotactic Body Radiation Therapy in Treating Patients With Inoperable Stage I or Stage II Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stereotactic Body Radiation Therapy (SBRT) n=55 Participants 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
Age, Continuous	72 years n=93 Participants
Sex: Female, Male Female	34 Participants n=93 Participants
Sex: Female, Male Male	21 Participants n=93 Participants

PRIMARY outcome

Timeframe: From the start of treatment to 2 years

Population: Eligible patients who started protocol treatment.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy (SBRT) n=55 Participants 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
Local Control at 2 Years	97.6 percentage of subjects Interval 84.3 to 99.7

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis occurred after all patients had been on study for at least 2 years. Maximum follow-up at time of analysis was 4.2 years.

Population: All eligible patients who started study treatment

Specified adverse events are defined as any treatment-related adverse events that are grade 4, grade 5, or any of the following treatment-related grade 3 adverse events: * Gastrointestinal: dysphagia, esophagitis, esophageal stricture, esophageal ulceration; * Cardiac: pericarditis, pericardial effusion, cardiomyopathy, ventricular dysfunction; * Neurologic: myelitis, neuropathy (cranial and motor) * Hemorrhage: pulmonary or upper respiratory * Pulmonary: decline in pulmonary function as measured by pulmonary function tests, pneumonitis, pulmonary fibrosis, hypoxemia, pleural effusion. Adverse events are graded using CTCAE v3.0. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy (SBRT) n=55 Participants 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
Proportion of Subjects With Specified Adverse Events	9 Participants

SECONDARY outcome

Timeframe: From the start of treatment to 2 years

Population: Eligible patients

Local failure is defined as the combination of primary tumor failure (PTF) or involved lobe failure (ILF). PTF was defined based on meeting two criteria: 1. Local enlargement defined as ≥ 20% increase in the longest diameter of the gross tumor volume (GTV) per computerized tomography (CT), and 2. Evidence of tumor viability. Tumor viability could be affirmed by either demonstrating positron emission tomography (PET) imaging with uptake of a similar intensity as the pretreatment staging PET, or by repeat biopsy confirming carcinoma. PTF included marginal failures occurring within 1 cm of the planning target volume (PTV). ILF is defined as failure beyond the primary tumor but within the involved lobe. Time to local recurrence is defined as time from start of treatment to the the date of local recurrence, last known follow-up (censored), or death without local recurrence (censored).

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy (SBRT) n=55 Participants 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
Rate of Local Recurrence at 2 Years	2.4 percentage of participants Interval 0.3 to 15.7

SECONDARY outcome

Timeframe: From the start of treatment to 2 years

Population: Eligible patients

Regional recurrence is defined as hilar, mediastinal, and supraclavicular nodal failure.Time to regional recurrence is defined as time from start of treatment to the date of first regional recurrence, last known follow-up (censored), or death without regional recurrence (competing risk). Rates are estimated using the cumulative incidence method.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy (SBRT) n=55 Participants 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
Rate of Regional Recurrence at 2 Years	0 percentage of participants Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: From the start of treatment to 2 years

Population: Eligible patients

Disseminated recurrence is defined as uninvolved lobe failures and failures beyond the lungs and regional lymph nodes. Time to disseminated recurrence is defined as time from start of treatment to the the date of disseminated recurrence, last known follow-up (censored), or death without disseminated recurrence (competing risk). Rates are estimated using the cumulative incidence method.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy (SBRT) n=55 Participants 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
Rate of Disseminated Recurrence at 2 Years	11.1 percentage of participants Interval 5.1 to 23.0

SECONDARY outcome

Timeframe: From the start of treatment to 2 years

Population: Eligible patients

Disease is defined as local or regional progression or development of distant metastases. Disease-free survival time is defined as time from start of treatment to the date of disease, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy (SBRT) n=55 Participants 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
Rate of Disease-free Survival at 2 Years	67.3 percentage of participants Interval 53.2 to 78.0

SECONDARY outcome

Timeframe: From the start of treatment to 2 years

Population: Eligible patients

Overall survival time is defined as time from start of treatment to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

Outcome measures

Outcome measures
Measure	Stereotactic Body Radiation Therapy (SBRT) n=55 Participants 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
Rate of Overall Survival at 2 Years	72.7 percentage of participants Interval 58.9 to 82.6

Adverse Events

Stereotactic Body Radiation Therapy (SBRT)

Serious events: 11 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Stereotactic Body Radiation Therapy (SBRT) n=55 participants at risk 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
Blood and lymphatic system disorders Lymphatics - Other	1.8% 1/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Cardiac general - Other	1.8% 1/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	1.8% 1/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dysphagia	1.8% 1/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Chest pain	1.8% 1/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	14.5% 8/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Forced expiratory volume	1.8% 1/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Metabolic/laboratory - Other	1.8% 1/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Weight decreased	1.8% 1/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Anorexia	3.6% 2/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycemia NOS	1.8% 1/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Insomnia	1.8% 1/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Cough	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.7% 7/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pneumonitis NOS	1.8% 1/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension NOS	1.8% 1/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory - Other	1.8% 1/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Other adverse events

Other adverse events
Measure	Stereotactic Body Radiation Therapy (SBRT) n=55 participants at risk 20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy stereotactic body radiation therapy
Blood and lymphatic system disorders Blood/bone marrow - Other	10.9% 6/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Blood and lymphatic system disorders Hemoglobin	23.6% 13/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Cardiac disorders Atrial fibrillation	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal pain NOS	7.3% 4/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea NOS	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	14.5% 8/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Vomiting NOS	9.1% 5/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Chest pain	14.5% 8/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Edema: limb	7.3% 4/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	38.2% 21/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain - Other	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pyrexia	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Rigors	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Infection with Grade 3 or 4 neutrop	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Dermatitis radiation NOS	10.9% 6/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Injury, poisoning and procedural complications Fracture NOS	16.4% 9/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Activated partial thromboplastin ti	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood alkaline phosphatase increase	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood bilirubin increased	7.3% 4/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Blood creatinine increased	10.9% 6/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Forced expiratory volume	16.4% 9/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Lymphopenia	9.1% 5/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Metabolic/laboratory - Other	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Pulmonary function test NOS decreas	9.1% 5/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Weight decreased	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycemia NOS	9.1% 5/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypoalbuminemia	9.1% 5/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypocalcemia	7.3% 4/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypokalemia	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyponatremia	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Chest wall pain	16.4% 9/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Muscle weakness NOS	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue - Other	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Myalgia	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Headache	7.3% 4/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral sensory neuropathy	7.3% 4/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Renal and urinary disorders Renal/genitourinary - Other	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Atelectasis	5.5% 3/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Cough	32.7% 18/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	54.5% 30/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.3% 4/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.1% 5/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pneumonitis NOS	14.5% 8/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory - Other	20.0% 11/55 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Additional Information

Wendy Seiferheld

Radition Therapy Oncology Group (RTOG)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place