Clinical trial · Interventional
G-CSF and Pegfilgrastim in Treating Neutropenia in Patients Undergoing Radiation Therapy and Chemotherapy for Limited Stage Small Cell Lung Cancer
A Phase II Trial of Combined Modality Therapy With Growth Factor Support for Patients With Limited Stage Small Cell Lung Cancer
- 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, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Colony-stimulating factors, such as G-CSF or pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy and radiation therapy. PURPOSE: This phase II trial is studying G-CSF and pegfilgrastim to see how well they work in treating neutropenia in patients undergoing combination chemotherapy and radiation therapy for 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Filgrastim | Drug | Filgrastim | ALIAS |
| Pegfilgrastim | Drug | Pegfilgrastim | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Combined Modality Therapy with Growth Factor Support
- description
- Concurrent radiation therapy, cisplatin, etoposide, and filgrastim followed by adjuvant cisplatin, etoposide, and pegfilgrastim.
- interventionNames
- Drug: Filgrastim
- Drug: Pegfilgrastim
- Drug: Etoposide
- Drug: Cisplatin
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Number of Patients With Grade 3-4 Febrile Neutropenia During Concurrent Chemoradiotherapy
- timeFrame
- From start of treatment to end of concurrent chemoradiation, for a maximum of 45 days
- description
- Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. No testing was done due to early study termination.
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
* Limited stage disease, defined as any of the following:
* Tumor confined to one hemithorax
* T4 tumor not based on malignant pleural effusion
* N3 disease not based on contralateral supraclavicular involvement
* No complete tumor resection
* Measurable or evaluable disease
* Pleural effusion allowed provided the following conditions are present:
* Effusion is too small to tap under CT guidance and is not evident on chest x-ray
* Effusion appears only after a thoracotomy or other invasive procedure
* Must have certification by a Radiation Oncologist that the tumor can be encompassed by limited radiotherapy fields without significantly compromising pulmonary function
* No distant metastases
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-1
* ANC (absolute neutrophil count) ≥ 1,800 cells/mm³
* Platelet count ≥ 100,000 cells/mm³
* Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0 g/dL allowed)
* Total bilirubin ≤ 1.5 mg/dL
* AST (aspartate aminotransferase) or ALT (alanine amino transferase ) ≤ 2 times the upper limit of normal (ULN)
* Alkaline phosphatase \< 2.5 times ULN (\< 5 times ULN if judged by the investigator to be related to liver metastases)
* Serum creatinine ≤ 1.5 mg/dL
* Creatinine clearance ≥ 50 mL/min
* FEV1 (Forced Expiratory Volume) obtained pre- or post-bronchodilator must be ≥ 1.5 liters/second
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 60 days after the last study treatment
* No prior invasive malignancy, except non-melanomatous skin cancer or other micro-invasive malignancy, or carcinoma in situ of the breast, oral cavity, or cervix, unless the patient has been disease-free for a minimum of 3 years
* No weight loss \> 5% for any reason within the past 3 months
* No severe, active comorbidity, defined as follows:
* Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
* Transmural myocardial infarction within the past 6 months
* Acute bacterial or fungal infection requiring intravenous antibiotics
* Chronic Obstructive Pulmonary Disease exacerbation with FEV1 (forced expiratory volume) \< 1.5 liters/second or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* AIDS (HIV testing not required for entry into this protocol)
* No prior allergic reaction to the study drugs
PRIOR CONCURRENT THERAPY:
* No prior systemic chemotherapy for lung cancer
* Prior chemotherapy for a different cancer is allowed, provided it was completed ≥ 5 years prior to registration
* No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields
* No concurrent intensity-modulated radiotherapy
* No concurrent amifostineReferences
Publications (1)
- BACKGROUNDLilenbaum R, Samuels M, Taffaro-Neskey M, Cusnir M, Pizzolato J, Blaustein A. Phase II trial of combined modality therapy with myeloid growth factor support in patients with locally advanced non-small cell lung cancer. J Thorac Oncol. 2010 Jun;5(6):837-40. doi: 10.1097/JTO.0b013e3181d6e141. PMID 20421820