Phase 2
N=72
Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00066222 ↗Enrolled (actual)
72
Serious AEs
94.4%
Results posted
Dec 2014
Primary outcome: Primary: Overall Survival at 2 Years — 36.60 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cisplatin (Drug); Etoposide (Drug); Radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival at 2 Years |
36.60 | — |
| SECONDARY Overall Survival (OS) and Progression-free Survival (PFS) at 1 Year |
77.5; 42.3 | — |
| SECONDARY Median Overall Survival Time and Progression-free Survival Time |
19.0; 9.9 | — |
| SECONDARY Number of Patients With Acute Treatment-related Grade 3 or 4 Esophagitis |
13 | — |
| SECONDARY Frequency of Treatment-related Fatalities at 2 Years |
2 | — |
| SECONDARY Tumor Response |
29; 28; 7; 4 | — |
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together with radiation therapy works in treating patients with limited-stage small cell lung cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell carcinoma of the lung by fine needle aspiration biopsy or two positive sputa
- Must have limited disease
- Stage I, II, IIIA, or IIIB
- Confined to 1 hemithorax, but excluding the following:
- T4 tumor based on malignant pleural effusion
- N3 disease based on contralateral hilar or contralateral supraclavicular involvement
- No pericardial or pleural effusions on chest x-ray (regardless of cytology)
- Measurable or evaluable disease
- Tumor must be able to be encompassed by limited radiotherapy fields without significantly compromising pulmonary function
- No prior complete tumor resection
PATIENT CHARACTERISTICS:
Age
- 18 to 100
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 150,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
Renal
- Creatinine no greater than 1.5 mg/dL
Cardiovascular
- No myocardial infarction within the past 6 months
- No symptomatic heart disease
Pulmonary
- No chronic obstructive pulmonary disease with Forced Expiratory Volume (FEV)-1 no greater than 0.8 liter
- No uncontrolled bronchospasm in the unaffected lung
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Available for follow-up
- No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or non-invasive in situ malignancies
- No other concurrent serious medical illness
- No uncontrolled psychiatric illness
- No chronic alcohol or drug abuse
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy to the chest or other area containing a large amount of bone marrow (e.g., more than 75% of pelvic bone)
Surgery
- See Disease Characteristics
Data sourced from ClinicalTrials.gov (NCT00066222). 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.