Trial Outcomes & Findings for Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer (NCT NCT00057746)

Last Updated: 2016-05-25

Results Overview

Chronic neurotoxicity is defined as a drop in one standard error of measurement (SEM) in any one of the three tests comprising the neuropsychological test battery (Hopkins Verbal Learning Test, Controlled Word Association Test, and Trail-Making Test) without development of brain metastasis by one year. The SEM is calculated as the standard deviation of the baseline test multiplied by the square root of one minus the published reliability coefficient for the test.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

265 participants

Primary outcome timeframe

From study registration to one year.

Results posted on

2016-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy	Arm II Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy	Arm III Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
Overall Study STARTED	131	67	67
Overall Study COMPLETED	131	67	66
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy	Arm II Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy	Arm III Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=131 Participants Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy	Arm II n=67 Participants Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy	Arm III n=66 Participants Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy	Total n=264 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	62 years n=7 Participants	61 years n=5 Participants	62 years n=4 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	33 Participants n=7 Participants	32 Participants n=5 Participants	118 Participants n=4 Participants
Sex: Female, Male Male	78 Participants n=5 Participants	34 Participants n=7 Participants	34 Participants n=5 Participants	146 Participants n=4 Participants

PRIMARY outcome

Timeframe: From study registration to one year.

Outcome measures

Outcome measures
Measure	Arm I n=45 Participants Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy	Arm II n=20 Participants Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy	Arm III n=19 Participants Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
Incidence of Chronic Neurotoxicity	60 percentage of participants Interval 48.0 to 72.0	85 percentage of participants Interval 72.0 to 98.0	89 percentage of participants Interval 78.0 to 100.0

Adverse Events

Arm I

Serious events: 6 serious events

Other events: 54 other events

Deaths: 0 deaths

Arm II

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

Arm III

Serious events: 4 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Arm I n=128 participants at risk Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy	Arm II n=66 participants at risk Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy	Arm III n=64 participants at risk Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
Gastrointestinal disorders Nausea or vomiting	16.4% 21/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	27.3% 18/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	17.2% 11/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
General disorders Fatigue	27.3% 35/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	37.9% 25/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	26.6% 17/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Nervous system disorders Headache	24.2% 31/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	31.8% 21/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	29.7% 19/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Psychiatric disorders Insomnia	3.9% 5/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	6.1% 4/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	6.2% 4/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.

Additional Information

Wendy Seiferheld

NRG Onoclogy

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	Arm I n=128 participants at risk Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy	Arm II n=66 participants at risk Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy	Arm III n=64 participants at risk Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
Gastrointestinal disorders Abdominal pain or cramping	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Dysphagia-esophageal related to radiation	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Nausea	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Gastrointestinal disorders Vomiting	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
General disorders Constitutional Symptoms - Other, Specify	0.00% 0/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	1.6% 1/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
General disorders Edema	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
General disorders Fatigue	0.00% 0/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	1.5% 1/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Investigations Weight loss	0.00% 0/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	1.6% 1/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Metabolism and nutrition disorders Anorexia	0.00% 0/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	1.6% 1/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Metabolism and nutrition disorders Hypocalcemia	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Metabolism and nutrition disorders Hypokalemia	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Metabolism and nutrition disorders Hypomagnesemia	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Metabolism and nutrition disorders Metabolic/laboratory-Other	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	1.5% 1/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Nervous system disorders Brain	0.00% 0/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	1.6% 1/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Nervous system disorders Confusion	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Nervous system disorders Neuropathy - motor	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Nervous system disorders Syncope	0.00% 0/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	1.6% 1/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Nervous system disorders Vertigo	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	3.1% 2/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary-Other	0.78% 1/128 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/66 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.	0.00% 0/64 Subjects experiencing more than one of a given serious adverse event (SAE) are counted only once for that SAE. The same methodology was applied for non-serious adverse events.