Phase 2
N=265
Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00057746 ↗Enrolled (actual)
265
Serious AEs
4.7%
Results posted
May 2016
Primary outcome: Primary: Incidence of Chronic Neurotoxicity — 60; 85; 89 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Prophylactic cranial irradiation, 2.5 Gy fx (Radiation); Prophylactic cranial irradiation, 2.0 Gy fx (Radiation); Prophylactic cranial irradiation, 1.5 Gy fx (Radiation)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Chronic Neurotoxicity |
60; 85; 89 | — |
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therapy.
PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens. The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately (NCT00005062).
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer by fine needle aspiration, biopsy, or 2 positive sputa
- Limited stage (I-IIIB)
- Confined to 1 hemithorax
- No T4 based on malignant pleural effusion, or N3 disease based on contralateral hilar or contralateral supraclavicular involvement
- Complete response after induction chemotherapy (with or without thoracic radiotherapy)
- Consolidative chest radiotherapy may be initiated before study
- No radiographic evidence of any of the following:
- Brain metastases
- Normal brain CT scan or MRI less than 1 month before study
- Ipsilateral lung metastases
- Malignant pleural effusion
- Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray
PATIENT CHARACTERISTICS:
Age
- Not specified
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 75,000/mm^3
- Hemoglobin at least 10.0 g/dL^
Hepatic
- Not specified
Renal
- Not specified
Pulmonary
- See Disease Characteristics
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Neurological function class 1 or 2
- No epilepsy requiring permanent oral medication
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No other serious medical or psychiatric condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- At least 1 week since prior chemotherapy
- No concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy
- Concurrent thoracic radiotherapy allowed
Surgery
- Not specified
Other
- No concurrent antitumor agents
Data sourced from ClinicalTrials.gov (NCT00057746). 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.