Phase 3 N=356 Randomized Treatment

Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer

Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00048997 ↗

Enrolled (actual)

356

Serious AEs

3.1%

Results posted

Oct 2014

Primary outcome: Primary: Overall Survival — 28.5; 25.3 months — p=0.2853

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Radiation therapy (Radiation); Observation (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Radiation Therapy Oncology Group
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Overall Survival	28.5; 25.3	0.2853
SECONDARY Percentage of Subjects With Deterioration in the Hopkins Verbal Learning Test - Revised (HVLT-R) Recall Score at One Year	26; 7	0.01 sig
SECONDARY Percentage of Subjects With Deterioration in the Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recall Score at One Year	32; 5	0.008 sig
SECONDARY Percentage of Subjects With Deterioration in Global Health Status From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) at One Year	22; 34	0.20
SECONDARY Percentage of Subjects With Deterioration in Cognitive Functioning From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) at One Year	41; 25	0.14
SECONDARY Percentage of Subjects With Deterioration in Fatigue From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) at One Year	34; 28	0.52
SECONDARY Percentage of Subjects With Deterioration in Future Uncertainty From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain-20 (EORTC QLQ-B20) at One Year	16; 21	0.51
SECONDARY Percentage of Subjects With Deterioration in Communications Deficit From the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Brain-20 (EORTC QLQ-B20) at One Year	39; 23	0.11
SECONDARY Number of Subjects With Central Nervous System (CNS) Metastases in the First Year	15; 36	0.005 sig

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if giving radiation therapy to the head is effective in preventing CNS metastases in patients who have stage III non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying how well radiation therapy to the head works in preventing CNS metastases in patients who have been previously treated for stage III non-small cell lung cancer.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of stage IIIA or IIIB non-small cell lung cancer
Complete response, partial response, or stable disease after definitive locoregional therapy (with surgery and/or radiation therapy, with or without chemotherapy (chemotherapy alone does not constitute definitive therapy))
No more than 16 weeks since prior therapy
No progressive disease
No extracranial distant metastatic disease
No suspicion of CNS metastases by MRI or CT scan

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

No other malignancy within the past 3 years except nonmelanoma skin cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent anticancer biologic therapy

Chemotherapy

See Disease Characteristics
No concurrent anticancer cytotoxic chemotherapy

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
No prior cranial irradiation

Surgery

See Disease Characteristics

Other

Recovered from all prior therapies
No concurrent enrollment on any other phase III study that has progression-free, disease-free, or overall survival as an endpoint

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00048997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.