Clinical trial · Interventional
Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer
NCT00066222CI-TRIAL-00030894completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation Therapy + Chemotherapy
- description
- Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
- interventionNames
- Drug: Cisplatin
- Drug: Etoposide
- Radiation: Radiation therapy
Primary outcomes (1)
- measure
- Overall Survival at 2 Years
- timeFrame
- From registration to 2 years
- description
- Survival time is defined as time from study registration to the date of death from any cause and survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 CharacteristicsReferences
Publications (3)
- RESULTKomaki R, Paulus R, Ettinger DS, Videtic GM, Bradley JD, Glisson BS, Langer CJ, Sause WT, Curran WJ Jr, Choy H. Phase II study of accelerated high-dose radiotherapy with concurrent chemotherapy for patients with limited small-cell lung cancer: Radiation Therapy Oncology Group protocol 0239. Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):e531-6. doi: 10.1016/j.ijrobp.2012.01.075. Epub 2012 May 5. PMID 22560543
- RESULTKomaki R, Paulus R, Ettinger DS, et al.: A phase II study of accelerated high-dose thoracic radiation therapy (AHTRT) with concurrent chemotherapy for limited small cell lung cancer: RTOG 0239. [Abstract] J Clin Oncol 27 (Suppl 15): A-7527, 2009.
- RESULTKomaki R, Moughan J, Ettinger D, et al.: Toxicities in a phase II study of accelerated high dose thoracic radiation therapy (TRT) with concurrent chemotherapy for limited small cell lung cancer (LSCLC) (RTOG 0239). [Abstract] J Clin Oncol 25 (Suppl 18): A-7717, 438s, 2007.