Trial Outcomes & Findings for Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer (NCT NCT01055197)

Last Updated: 2018-12-12

Results Overview

Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months. The 12-month rate is reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

97 participants

Primary outcome timeframe

From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.

Results posted on

2018-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	Prophylactic Cranial Irradiation Prophylactic Cranial Irradiation (PCI)	Prophylactic Cranial Irradiation + Consolidation Radiotherapy Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
Overall Study STARTED	51	46
Overall Study COMPLETED	42	44
Overall Study NOT COMPLETED	9	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Prophylactic Cranial Irradiation Prophylactic Cranial Irradiation (PCI)	Prophylactic Cranial Irradiation + Consolidation Radiotherapy Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
Overall Study Protocol Violation	7	2
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prophylactic Cranial Irradiation n=42 Participants Prophylactic Cranial Irradiation (PCI)	Prophylactic Cranial Irradiation + Consolidation Radiotherapy n=44 Participants Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease	Total n=86 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	66 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.

Population: All eligible patients who started study treatment

Outcome measures

Outcome measures
Measure	Prophylactic Cranial Irradiation n=42 Participants Prophylactic Cranial Irradiation (PCI)	Prophylactic Cranial Irradiation + Consolidation Radiotherapy n=44 Participants Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
Overall Survival (12-month Rate Reported)	60.1 percentage of participants Interval 41.2 to 74.7	50.8 percentage of participants Interval 34.0 to 65.3

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.

Population: All eligible patients who started study treatment

Adverse events (AE) are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 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	Prophylactic Cranial Irradiation n=42 Participants Prophylactic Cranial Irradiation (PCI)	Prophylactic Cranial Irradiation + Consolidation Radiotherapy n=44 Participants Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event	24 percentage of participants Interval 12.0 to 39.0	36 percentage of participants Interval 22.0 to 52.0

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.

Population: All eligible patients who had a failure

Failure was defined as progressive disease in areas treated with radiation development of measurable disease at sites that had achieved a complete response either with chemotherapy prior to study entry or following radiation, or development of new disease characteristic of small-cell lung cancer dissemination as determined by imaging \[per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\] and physical examination. A patient could be counted in more than one category.

Outcome measures

Outcome measures
Measure	Prophylactic Cranial Irradiation n=32 Participants Prophylactic Cranial Irradiation (PCI)	Prophylactic Cranial Irradiation + Consolidation Radiotherapy n=31 Participants Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
Patterns of Failure - Number of Patients With Failure by Site Failure at any time at new site	10 Participants	19 Participants
Patterns of Failure - Number of Patients With Failure by Site 1st failure site = diagnosis site	25 Participants	13 Participants
Patterns of Failure - Number of Patients With Failure by Site 1st failure site = locoregional disease	20 Participants	8 Participants
Patterns of Failure - Number of Patients With Failure by Site 1st failure site = brain	0 Participants	6 Participants

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.

Population: All eligible patients

Failure was defined as progressive disease in areas treated with radiation development of measurable disease at sites that had achieved a complete response either with chemotherapy prior to study entry or following radiation, or development of new disease characteristic of small-cell lung cancer dissemination as determined by imaging \[per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\] and physical examination. Time to first failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death (competing risk). First failure rates are estimated using the cumulative incidence method.

Outcome measures

Outcome measures
Measure	Prophylactic Cranial Irradiation n=42 Participants Prophylactic Cranial Irradiation (PCI)	Prophylactic Cranial Irradiation + Consolidation Radiotherapy n=44 Participants Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
First Failure (12-month Rate Reported)	79.6 percentage of participants Interval 60.6 to 90.2	75.0 percentage of participants Interval 57.9 to 86.0

SECONDARY outcome

Timeframe: From start to end of radiation therapy; up to 32 days for Prophylactic Cranial Irradiation arm, up to 68 days for Prophylactic Cranial Irradiation + Consolidation Radiotherapy arm.

Population: All eligible patients who started study treatment

Total dose to the brain was to be 25 Gy for all patients. For patients on PCI+consolidative RT, patients were to get 45 Gy at 3 Gy per fraction to the locoregional area as well as to residual metastatic disease. Alternatively, these regions could have received 30-40 Gy in 10 fractions. The total planned dose was determined, and a percentage was calculated based for each patient as total delivered dose / total planned dose.

Outcome measures

Outcome measures
Measure	Prophylactic Cranial Irradiation n=42 Participants Prophylactic Cranial Irradiation (PCI)	Prophylactic Cranial Irradiation + Consolidation Radiotherapy n=44 Participants Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
Percentage of Planned Radiotherapy Dose (All Sites) That Was Delivered	100 percentage of planned dose delivered Interval 70.0 to 100.0	100 percentage of planned dose delivered Interval 62.0 to 115.0

Adverse Events

Prophylactic Cranial Irradiation

Serious events: 1 serious events

Other events: 37 other events

Deaths: 0 deaths

Prophylactic Cranial Irradiation + Consolidation Radiotherapy

Serious events: 6 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

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	Prophylactic Cranial Irradiation n=42 participants at risk Prophylactic Cranial Irradiation (PCI)	Prophylactic Cranial Irradiation + Consolidation Radiotherapy n=44 participants at risk Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
Cardiac disorders Sinus tachycardia	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Diarrhea	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Esophagitis	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Lung infection	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.5% 2/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Infections and infestations Upper respiratory infection	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Platelet count decreased	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations White blood cell decreased	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Dehydration	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Lethargy	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Anxiety	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Delirium	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.5% 2/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Hypotension	0.00% 0/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.5% 2/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Vascular disorders Thromboembolic event	2.4% 1/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.

Measure	Prophylactic Cranial Irradiation n=42 participants at risk Prophylactic Cranial Irradiation (PCI)	Prophylactic Cranial Irradiation + Consolidation Radiotherapy n=44 participants at risk Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
Blood and lymphatic system disorders Anemia	16.7% 7/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	20.5% 9/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Ear and labyrinth disorders Ear and labyrinth disorders - Other	7.1% 3/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Eye disorders Blurred vision	7.1% 3/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.8% 3/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Abdominal pain	9.5% 4/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.8% 3/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Constipation	14.3% 6/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	22.7% 10/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dyspepsia	9.5% 4/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.8% 3/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Dysphagia	7.1% 3/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	25.0% 11/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Nausea	38.1% 16/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	31.8% 14/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Gastrointestinal disorders Vomiting	19.0% 8/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.8% 3/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Fatigue	64.3% 27/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	59.1% 26/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
General disorders Pain	11.9% 5/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.6% 6/44 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	9.5% 4/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.6% 6/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Platelet count decreased	7.1% 3/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	11.4% 5/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Investigations Weight loss	19.0% 8/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	22.7% 10/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Anorexia	14.3% 6/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	43.2% 19/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Dehydration	7.1% 3/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.8% 3/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyperglycemia	11.9% 5/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.8% 3/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypocalcemia	7.1% 3/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.5% 2/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hypokalemia	7.1% 3/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.1% 4/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Metabolism and nutrition disorders Hyponatremia	7.1% 3/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.1% 4/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Back pain	7.1% 3/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.8% 3/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 3/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	0.00% 0/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dizziness	7.1% 3/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	11.4% 5/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Dysgeusia	7.1% 3/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.6% 6/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Headache	40.5% 17/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	13.6% 6/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Memory impairment	11.9% 5/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.8% 3/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Nervous system disorders Peripheral sensory neuropathy	9.5% 4/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.8% 3/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Anxiety	11.9% 5/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.1% 4/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Psychiatric disorders Depression	9.5% 4/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.1% 4/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Cough	11.9% 5/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	27.3% 12/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Dyspnea	19.0% 8/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	27.3% 12/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Respiratory, thoracic and mediastinal disorders Productive cough	9.5% 4/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	9.1% 4/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Alopecia	26.2% 11/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	31.8% 14/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Dry skin	14.3% 6/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	4.5% 2/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Pruritus	9.5% 4/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	6.8% 3/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	7.1% 3/42 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.	2.3% 1/44 Subjects experiencing more than one of a given adverse event are counted only once for that adverse event.